clinical research organisations denmark

Welcome to the Copenhagen Trial Unit − The CTU

The CTU is a clinical intervention research unit conducting clinical research within all specialties. We offer flexible collaboration and consulting at all stages of clinical research.

The CTU has been involved in the conduct of more than 162 randomised clinical trials in which more than 135,000 participants were randomised. We provide expertise and infrastructure in planning, conduct, analysis, and interpretation of randomised clinical trials, including development of trial methodology and education.

The CTU has been involved in the conduct of more than 500 protocols for systematic reviews, which has materialised in the publication of more than 300 systematic reviews published within and outside The Cochrane Collaboration. The CTU has developed methodology and software for conducting Trial Sequential Analysis (TSA). We provide advice, support, and full collaboration during the protocol and systematic review development. We offer expertise in search strategy design, conduct literature searches for systematic reviews, and offer help with or conduct of meta-analyses.

The CTU hosts the Editorial Team Office of the  Cochrane Hepato-Biliary Group (CHBG) – one of the 56 global Collaborative Review Groups within The Cochrane Collaboration – as well as the Danish Clinical Research Infrastructures Network (DCRIN) and the Danish coordinating hub of the Nordic Trial Alliance (NTA) .

Since the establishment in 1995, the CTU has produced an average of 38 publications per year. By August 2024, the CTU had a Web of Science Hirsch index of 103.

We offer creative collaboration and consulting from concept, through conduct and to completion.

Hello world

DanTrials ApS is a private Danish contract research organisation (CRO) dedicated to efficient clinical research in healthy volunteers and patients.

We perform a wide range of clinical studies in our 10-bed fully equipped clinical pharmacology research unit located at Copenhagen University Hospital, Bispebjerg.

Being hospital-based, we have ideal possibilities to conduct clinical studies in a variety of patient populations and to interact with experts within many different therapeutic fields. Further, we hold a Research Subject Database which ensures swift recruitment of healthy subjects for classical phase I studies.

Our competent and experienced staff are committed to make your clinical study a true success: be it single-site testing of the first human dose or later stage clinical studies where we participate as one of many clinical sites.

Vi søger (18‑55 år) til lægemiddelforsøg (SIS‑01).

Klik for at læse mere.

Vi søger (18‑45 år) til lægemiddelforsøg (KBP‑336‑CD‑001).

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• Executive Management
• Board of Directors
• Our Publications
• Upcoming Events

Welcome to Sanos Group

Full circle clinical research and development, we provide first-class clinical research.

Sanos Group is a Full Circle Clinical Research and Development Organization encompassing six independent business units: NBCD , Sanos Clinic , Sanos Supply , Studies&Me , Blueskin and Omicron .

We are headquartered in Soborg outside Copenhagen, Denmark, where we share the building with NBCD, Blueskin and Omicron.

All business units in the Sanos Group are dedicated to providing first-class clinical research, aiming to keep improving and develop how we conduct innovative clinical trials for our clients and patients. We play a critical role in developing new medication and treatment options, and work diligently to bring new medication faster to the patients.

We are acknowledged for our scientific expertise, and long track record of efficient and innovative clinical trials.

Sanos Group is an organization in rapid development, which means that we rely on our agility and efficiency. At present, Sanos Group consists of around 200 employees, and we are experiencing continuous growth.

• Help & FAQ
• Department of Clinical Research
• University of Southern Denmark
• The Faculty of Health Sciences
• Phone 65 50 92 54
• Website https://www.sdu.dk/en/om_sdu/institutter_centre/klinisk_institut

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• Cohort Analysis Medicine and Dentistry 100%
• Disease Medicine and Dentistry 96%
• Systematic Review Medicine and Dentistry 69%
• Cohort Study Pharmacology, Toxicology and Pharmaceutical Science 69%
• Symptom Medicine and Dentistry 64%
• Randomized Controlled Trial Medicine and Dentistry 60%
• Diagnosis Medicine and Dentistry 52%
• Malignant Neoplasm Medicine and Dentistry 49%

Collaborations and top research areas from the last five years

Dive into details.

Select a country/territory to view shared publications and projects

Researchers

• KI, OUH, Research unit of Open - Bandim - Professor

Person: VIP

Katrine Saldern Aagaard

• Department of Clinical Research - VIP

Claus Aalykke

• KI, OUH, Research unit of Medicine (Svendborg) - Clinical lector

Louise Aarup Duus

• KI, OUH, Research unit of Radiology (Odense) - VIP

Ahmed Jibril Abdi

Research output.

• 28400 Journal article
• 3358 Poster
• 3124 Conference abstract in journal
• 1985 Conference abstract for conference
• 1363 Book chapter
• 1097 Comment/debate
• 815 Ph.D. thesis
• 378 Editorial
• 240 Net publication - Internet publication
• 162 Article in proceedings
• 157 Conference abstract in proceedings
• 152 Monograph
• 120 Contribution to newspaper - Newspaper article
• 110 Other contribution
• 85 Conference article
• 56 Contribution to newspaper - Comment/debate
• 52 Report chapter
• 48 Contribution to newspaper - Feature article
• 45 Sound/Visual production (digital)
• 35 Anthology
• 32 Literature review
• 29 Encyclopedia chapter
• 25 Memorandum
• 23 Compendium/lecture notes chapter
• 22 Working paper
• 20 Preface/postscript
• 19 Question & Answer/hearing
• 18 Doctoral Thesis
• 7 Compendium/lecture notes
• 7 Contribution to newspaper - Review
• 3 Question & Answer/hearing contribution
• 3 Interactive production
• 3 Computer programme
• 2 Exhibition
• 1 2D/3D (psysical product)

Research output per year

[18F]FDG PET/CT for identifying the causes of fever of unknown origin (FUO)

Research output : Contribution to journal › Journal article › Research › peer-review

• Positron Emission Tomography-Computed Tomography 100%
• Fluorodeoxyglucose F 18 100%
• Fever of Unknown Origin 100%
• Fluorine-18 100%
• Diagnosis 25%

2023 JTT statistics and acknowledgements

Research output : Contribution to journal › Editorial › peer-review

2023 MASCC and ESMO guideline update for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting

• Practice Guideline 100%
• Radiotherapy 100%
• Nausea and Vomiting 100%
• Radiation Therapy 100%
• Anticarcinogen 66%

2023 updated MASCC/ESMO consensus recommendations: controlling nausea and vomiting with chemotherapy of low or minimal emetic potential

• Emetic Agent 100%
• Vomiting 66%
• Antiemetic 50%
• Cancer Treatment 33%

2023 Updated MASCC/ESMO Consensus Recommendations: prevention of radiotherapy- and chemoradiotherapy-induced nausea and vomiting

• Antiemetic Agent 100%
• Chemoradiation Therapy 100%
• Antiemetic 100%
• 7710 Talks and presentations in private or public companies
• 3749 Conference organisation or participation
• 2516 Organisation or participation in workshops, courses or seminars
• 2000 Peer review of manuscripts
• 1902 Conference presentations
• 1490 Membership of commitees, commissions, boards, councils, associations, organisations, or similar
• 919 Membership of review committee
• 780 Guest lectures, external teaching and course activities at other universities
• 383 Board duties in companies, associations, or public organisations
• 312 Examination
• 309 Membership of research networks or expert groups
• 227 External supervisor activities
• 200 Consultancy
• 166 Editor of research journal
• 127 Visiting another research institution
• 107 Internal examination
• 12 Editor of series
• 9 Public sector consultancy
• 7 Editor of unfinished research anthology/collection
• 7 Hosting a guest lecturer
• 7 Academic management

Activities per year

2024 fyrværkeriskader OUH-landsoversigt

Jens Lauritsen (Speaker)

Activity : Talks and presentations › Talks and presentations in private or public companies

Detection and prevention of rollover at above-conversational speech levels

Neher, T. (Keynote speaker)

Activity : Talks and presentations › Conference presentations

Is heart rate associated with listening motivation during real-world speech communication for adult hearing aid users?

Andersson, K. E. (Guest lecturer), Neher, T. (Co-author) & Christensen, J. H. (Co-author)

Rehabilitation after hand surgery: Health professionals’ and patients’ decision -making

Boel, S. (Speaker), Kristensen, H. K. (Co-author), Vinther, A. (Co-author), Landgren, M. (Co-author) & Hansen, A. Ø. (Co-author)

Associations between heart rate and listening motivation in speech communication-related situations for adult hearing aid users

Andersson, K. E. (Author), Christensen, J. H. (Co-author) & Neher, T. (Co-author)

• 49 Not started
• 330 Finished

Projects per year

Percutaneous Vertebroplasty vs. Sham for Osteoporotic Vertebral Compression Fractures focusing on Pain and Economy: A Single-center, Double-blind Randomized controlled Clinical Trial

Andersen, M. Ø. (Project participant), Hartvigsen, J. (Project participant), Andresen, A. D. K. (Project participant), Hermann, A. P. (Project participant), Sørensen, J. (Project participant) & Carreon, L. (Project participant)

01/01/2024 → 31/10/2028

Project : Research

Smerter, posttraumatiske symptomer og seksuelle overgreb

Hansen, M. (PI), Hansen, N. B. (Co-PI), Vægter, H. B. (Project participant) & Andersen, T. E. (Co-PI)

01/09/2025 → 31/08/2028

BRAVE: Balancing everyday life as parents in vulnerable positions with a child newly diagnosed with type 1 diabetes (T1D)

Joensen, M. B. (PhD student), Lindahl-Jacobsen, L. (Project participant), Beck, M. (Supervisor), Mærsk, J. L. (Supervisor) & Kristensen, H. K. (Supervisor)

05/08/2024 → 31/07/2028

Project : PhD Project

WP5-PI: Ethical challenges of stem cell research and treatment.

Christensen, A.-M. S. (Project participant)

01/03/2024 → 29/02/2028

Project : Regional Foundations

Safety and Efficacy of Capsule FMT in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases

Kragsnæs, M. S. (PI) & Ellingsen, T. (PI)

01/01/2023 → 31/12/2027

Using the full PICO model as a search tool for systematic reviews resulted in lower recall for some PICO elements. Data extraction

Frandsen, T. F. (Creator), Nielsen, M. F. B. (Creator), Lindhardt, C. L. (Creator) & Eriksen, M. B. (Creator), Unknown, 2020

Data for: "Relapse prevention in ambulant mental health care tailored to patients with schizophrenia and bipolar disorder: A systematic literature review"

Johansen, K. K. (Creator) & Frandsen, T. F. (Creator), Syddansk Universitet, 20. Nov 2021

DOI : 10.21996/pd83-sn98

Protocol for statistical analyses in the study entitled "Pesticide exposure, asthma and diabetes in Uganda (PEXADU)"

Hansen, M. R. H. (Creator), Jørs, E. (Creator), Sandbæk, A. (Creator), Sekabojja, D. (Creator), Ssempebwa, J. (Creator), Neebye, R. M. (Creator), Staudacher, P. (Creator), Fuhrimann, S. (Creator), Hassan Hansen, W. A. (Creator) & Schlünssen, V. (Creator), Zenodo.org, 4. Sept 2019

DOI : 10.5281/zenodo.3386273

Modelling studies on preventive measures and treatments for Covid-19

Riveros, C. (Creator), Julia, C. (Creator), Chevance, A. (Creator), Quirke, F. (Creator), Boutron, I. (Creator), Chaimani, A. (Creator), Devane, D. (Creator), Meerpohl, J. J. (Creator), Tovey, D. (Creator), Hróbjartsson, A. (Creator) & Ravaud, P. (Creator), Zenodo, 17. Jun 2020

DOI : 10.5281/zenodo.3898626

Efficacy of high-intensity aerobic exercise on brain MRI measures in multiple sclerosis

Langeskov-Christensen, M. (Creator), Grøndahl Hvid, L. (Creator), Fristed Eskildsen, S. (Creator), Karl Emil Nygaard, M. (Creator), Ringgaard, S. (Creator), Boye Jensen, H. (Creator), Hvilsted Nielsen, H. (Creator), Petersen, T. (Creator), Stenager, E. (Creator) & Dalgas, U. (Creator), Dryad Digital Repository, 16. Apr 2021

DOI : 10.5061/dryad.3ffbg79fs

Press/Media

”har du brug for 2” ny kampagne om nyredonation vækker kritik.

Bistrup, C.

1 Media contribution

Press/Media : Press / Media

Nyt center skal løfte behandling til nye højder

Henriksen, J. E.

"Har du brug for 2?" Ny kampagne om nyredonation kritiseres for at være "grådig"

Diabetescenter venter på nyt ouh-afklaring, lea helmuth er intimkoordinator: man ville jo ikke bede birte i hr om at gå hen og kramme sin nøgne kollega.

Klausen, S.

"Exceptional Young Scientist Abstract"

Birkelund, L. (Recipient), 29. Aug 2024

Prize : Prizes, scholarships, distinctions

Fondbevilling fra Tværs Puljen, Region Hovedstaden

Boel, S. (Recipient), 12. Jun 2024

Travel Grant from the Danish Lung Association

Falster, C. (Recipient), 1. May 2024

Digitaliseringsprisen i kategorien publikumsprisen

Trettin, B. (Recipient), 5. Mar 2024

Best Research Presentation Abstract - European Congress of Radiology 2024

Elhakim, M. T. (Recipient), Feb 2024

Teaching & Supervision

Hovedvjelder marie.

Course : Teaching and supervision › Supervision

Medvejleder Ask

Hovedvejelder Sabine

Standardizing Measurement of Effect as well as Attaining and Reporting the Best General Strengthening Training Program regarding Frequency, Intensity, Time, and Type

Course : Supervision

Medvejleder af Phd studerende Frederik

Magtens top 100 i sundhedsvæsnet 2021 (nr. 49)

Sodemann, M. (Participant)

Impact : Public policy impact

TwiLi score

Impact : Academic impact

Dagens Medicin: De 100 mest magtfulde i sundhedsvæsnet

Twili impact index, ntcp model validation for selection of patients to a randomized controlled trial, dahanca35..

Christian Rønn Hansen (Participant)

• ICH GCP (De)
• ICH GCP (En)
• ICH GCP (Es)
• ICH GCP (Fr)
• ICH GCP (It)
• ICH GCP (Pt)
• ICH GCP (Ru)
• AUSTRALIA (NHMRC)
• JAPAN (PMDA)
• US Clinical Trials Registry
• EU Clinical Trials Registry
• Pharmaceutical Companies
• Clinical Research Labs
• Service Companies
• Clinical Research Events
• Publications
• Researchers

MAC Clinical Research® in Denmark

E-mail:   [email protected]

Web:   https://www.macplc.com/

• Contract research organizations
• MAC Clinical Research®

Lautrupsgade 7, 3. tv. 2100 København Ø Denmark

Other MAC Clinical Research®'s locations around the world

• United Kingdom
• United States

About MAC Clinical Research®

MAC Clinical Research is one of Europe’s largest contract research organisations (CRO), committed to providing full-service delivery of global clinical studies. Headquartered in the UK with offices globally, we conduct studies both through our fully-owned network of dedicated research sites in the UK and through contracting with sites across the globe. We offer the global clinical study management you need to meet your clinical outcome goals. Although our heritage stems from being the first memory assessment centre based in Europe, our company conducts research for sponsors over an ever-expanding group of therapeutic areas. MAC has an extensive range of clinical research capabilities to accommodate the most complex Phase I trials (in our MHRA-accredited Phase I unit) through to Phase IV (across our network of late-phase dedicated research sites). The majority of our current work includes diseases of the central nervous system (CNS), such as Alzheimer's disease and multiple sclerosis, as well as analgesics (acute and chronic pain), dermatology (psoriasis and eczema), rheumatology (fibromyalgia and arthritis), endocrinological diseases (e.g., diabetes), depression, anxiety, and insomnia.

List of CROs by location

• Bosnia & Herzegovina
• Czech Republic
• Netherlands
• Switzerland
• Dominican Republic
• El Salvador
• Saint Lucia
• Trinidad & Tobago
• Philippines
• Saudi Arabia
• South Korea
• Turkmenistan
• United Arab Emirates
• Burkina Faso
• Congo, DR of
• Cote d'Ivoire
• Equatorial Guinea
• South Africa
• New Zealand
• Papua New Guinea

MedTech / IVD

• Pharma / Biotech
• Marketing Compliance
• Clinical Operations
• Clinical Project Management
• Medical Advice
• Medical Writing
• Data Management
• Biostatistics
• Safety & Pharmacovigilance
• Market Access & RWE
• Quality Assurance
• Pre-clinical Stage & CMC
• Phase I / First in Human
• Phase II-III
• Phase IV & RWE Registries
• Clinical Investigations & Diagnostics
• Post Marketing Services
• IVDD to IVDR Transition
• Decentralized Trials
• Safety Database
• Strategic Advice Group
• Start Up Group
• Outsourcing
• Nordic Benefits
• Therapeutic Experience
• Geographic reach
• Customer Testimonials & Case Studies

Contract Research Organization

Your nordic contract research organization (cro) and regulatory service partner, with global reach, offering a wide range of services in northern europe and beyond for.

Biotech / Pharma

From Concept & Strategy to Commercialization

• Concept & Strategy
• Development
• Commercialization

A strong Nordic culture underpins our high-quality service based on respect, work integrity and focus on solutions.

We have the flexibility to deliver the support you need, no matter how big or small your project.

Our leading experts and technologies ensure we always follow industry advances and current regulations.

We offer wide ranging services to pharma and medical device industries for your entire product development journey.

Our strengths

Why choose link medical.

Become regulatory confident

The regulatory experts at LINK Medical can guide your company through the entire regulatory pathway. Additionally we can perform a GAP analysis to assure you have the right documentation to enter the clinical phase.

They are particularly well versed in the maintenance of marketing authorization of a product, label translations and marketing compliance.

Experts in clinical methodology for all phases

LINK Medicals employees are proud to be experts in the methodology of all clinical trial phases, regardless of complexity or indication. We have specially long experience from early oncology phase I studies. Additionally, we excel in handling the complex international phase II and smaller phase III studies, all with successful delivery and high quality through our adaptive and rigid processes.

Small enough and Big enough

We are the flexible contract research organization (CRO) with solid, established processes: not only are we agile enough to be adaptive to the needs of small customers but also big enough to handle complex international studies, including smaller phase III studies.

Why not engage LINK Medical as your local preferred provider for late phase studies?

Rigid processes with quality as a strong focus

Since we are audited several times each year by international companies, both big pharma and smaller companies, we constantly receive feedback on our Standard Operating Procedures (SOPs). Consequently, we are confident that we are up to date with all the latest requirements and regulations.

LINK Medical

Your trusted strategic cro and regulatory partner.

LINK Medical is a leading Contract Research Organization and Regulatory service provider offering experts, flexible services, and innovative technologies across Northern Europe and beyond. Additionally, our transparent Nordic culture provides a high-quality service delivery based on respect, work integrity and a strong focus on solutions.

clinical trials

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• Monday 27 May 2024

Clinical Trials in Alzheimer

• Thursday 16 May 2024

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• Tuesday 9 April 2024

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• Phase I – III
• Phase IV & RWE
• Resourcing Solutions
• Functional Services (FSP)
• Dermatology, Immunology & Inflammatory Diseases
• Internal Medicine
• Neuroscience
• Oncology & Hematology
• Ophthalmology
• Rare Diseases & Orphan Drugs
• Global Presence
• Sustainability
• Investigators
• Case Studies
• Infographics
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• White Papers
• Request a Proposal

Clinical Research Excellence

Strategic growth to support our customers and bring treatments to patients faster

Trust Quality Passion Flexibility Sustainability

We’re all in this together. We’re all here for you.

Global in Mind, Local at Heart

Learn about the TFS Journey and our tailored solutions. TFS

TFS HealthScience supports biotech and pharmaceutical companies with tailored clinical development and resource solutions. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver. With TFS you get a shared commitment to your success. Expect more.

Clinical Development

Scientific and operational experts tailor solutions to meet the needs of your project from regulatory strategy and clinical operations phases I-III to post-authorization and real-world evidence studies.

Insource a single critical need to a fully managed team. Our flexible staffing and recruitment services provide high-quality performance, expertise, and dedication to bringing your products to market faster.

From global end-to-end clinical development to a single service, we create fit-for-purpose FSP outsourcing models that approach your clinical workforce management efficiently and cost-effectively.

Our Expertise

TFS demonstrates scientific and medical excellence across a broad therapeutic spectrum with industry-leading capabilities in the following areas:

A global network of more than 6,000 sites and our own in-house experts and clinic

More than 3,000 partner sites and over 350 studies in the last 5 years

Over 150 full-service clinical studies across neurology, psychiatry, and pain indications

Nearly 9,000 patients across about 800 partner sites in the last 5 years

Specialized senior expertise and global advisors complemented by over 500 partner sites

Real World Evidence

We help bridge the gap between clinical trials and clinical practice by delivering quality evidence and reliable outcomes. TFS has pragmatic Phase IV trials across a broad range of indications at over more than 20 years of experience designing and running global non-interventional studies (NIS) at nearly 7,000 sites worldwide.

Virtual Studies: Decentralized study solutions to reach participants where they are and keep your study on track

No industry is immune to the effects of the COVID-19 global pandemic. The clinical trials industry has witnessed increasing acceptance of virtual data and communication technologies by physicians, patients, ethics committees, regulatory agencies, and sponsors. TFS has expertise managing large global clinical studies using the latest technologies all integrated through our digital platform to reach patients where they are. For 25 years our customers have trusted us with their clinical development programs, and now more than ever, we are prepared to offer tailored solutions to meet customer challenges, no matter the size.

Expert & Talent Solutions

With more than 25 years of experience in the Health Science industry customers turn to us as their first choice when looking for advisory or project support. Our network of key opinion leaders, subject matter experts and industry leading talent is available to help with critical business decisions and the delivery of key project milestones.

TFS HealthScience is a global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development process.

In partnership, we build solution-driven teams of experienced professionals working together for a healthier future. TFS provides scientific expertise and a full scope of services and resourcing solutions to allow you to stay focused on health innovations. Explore how our solutions can help drive your clinical research.

Motivated by results and driven by passion for great work, we are a team with a common goal: to bring treatments to patients faster. What we do thrills us and we’re looking for amazing people to join our team. Find your place with us.

• Feasibility Process
• Investigator Identification
• Facilitating infrastructures for clinical trials
• Clinical Trials of Tomorrow
• Organisation

Board of Directors

• Mission, vision and history
• Trial Nation Centers
• Trial Nation Networks
• Trial Nation Unions
• Other therapeutic areas
• Ready-to-use templates
• Requirement to contractual amendment
• Companies with contract templates for industry initiated clinical trials
• About Clinical Trials
• Annual Reports

Trial Nation is led by a board composed of five industry members, one member from each of the five Danish regions, one member from the following: the Ministry of Industry, Business and Financial Affairs, the Ministry of Health, the umbrella organisation Danish Patients and the Organisation of Danish Medical Societies (LVS).

• Patient Organisations and Medical Societies

Trial Nation is a member-based association. The Ministry of Industry, Business and Financial Affairs, The Ministry of Health, and the five Danish Regions are members representing the Danish healthcare system and the Danish State. The umbrella organisation for patient organisations in Denmark, Danish Patients and the Organization of Danish Medical Societies are members representing their respective spheres. Private life science companies with an interest in and competencies within clinical research can apply for membership according to the Trial Nation statutes, which are available in Danish only, here. 

Please see an overview of our members here:

Trial Nation contributes substantially to Denmark’s position as the leading public-private ecosystem for clinical trials in Europe – to the benefit of patients, research and the economy.

• We create the foundation for expansion, and we maintain a position for Denmark among the top three countries in Europe, measured as number of clinical trials per million inhabitants.
• We strengthen frameworks and conditions to attract significantly more clinical trials at the highest international level.
• We lead in state-of-the-art methods and technologies in set-up and execution of clinical trials.

Trial Nation is the result of strong and continuous governmental support of the Danish life science sector. The organisation is supported by the Ministry of Industry, Business and Financial Affairs and the five Danish Regions.

In 2014 the precursor to Trial Nation, NEXT Partnership, was established with political and industrial endorsement. The Innovation Fund Denmark contributed with a large investment.

In late 2018 Trial Nation was founded as a merge between NEXT Partnership (Funded by the Innovation Fund Denmark and members in the partnership) and Clinical Trials Office Denmark (Funded by the five Danish Regions).

In 2019 Trial Nation became the first Danish Associated Partner to an IMI project. The project is the flagship project Health Outcomes Observatories (H2O).

In 2021 Trial Nation was tasked with overseeing the establishment of the first real-time updated overview of recruiting clinical trials, allowing patients and health-care professionals to find clinical trials that may be suitable for them.

Launch is expected 2023.

In 2022 Danish Patients and Organisation of Danish Medical Societies changed their status from observatory members to full members on the board of Trial Nation.

Trial Nation Nørregade 7B 1165 Copenhagen Denmark

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Clinical Research, Department of

• The Capital Region of Denmark
• Nordsjællands Hospital
• Email [email protected]

Dyrehavevej 29 , Indgang 58, plan 3

3400 Hillerød

Organisation profile

Department of Clinical Research strives to create synergy and connections between new and established research environments across the hospital and to mediate collaboration with external private and public collaborators.

Head of research, Chief Physician, Professor

Thea Kølsen Fischer

[email protected]

Senior researcher, PhD, Physiotherapist

Stig Mølsted

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• Confidence Interval Keyphrases 100%
• Type 1 Diabetes Mellitus (T1DM) Keyphrases 94%
• Denmark Keyphrases 83%
• COVID-19 Keyphrases 81%
• Type I Diabetes Keyphrases 78%
• Cohort Analysis Medicine and Dentistry 75%
• Respiratory Syncytial Virus Keyphrases 60%
• Heart Failure Keyphrases 59%

Collaborations and top research areas from the last five years

Dive into details.

Select a country/territory to view shared publications and projects

Amanda Marie Egeskov-Cavling

• Nordsjællands Hospital , Clinical Research, Department of - PhD student

• Nordsjællands Hospital , Clinical Research, Department of - Forskningschef

Susanne Grøn Nielsen

• Nordsjællands Hospital , Clinical Research, Department of - Projektleder

Research output

• 447 Journal article
• 5 Book chapter
• 3 Comment/debate
• 3 Conference abstract in journal
• 3 Other contribution
• 1 Editorial
• 1 Memorandum
• 1 Working paper

Research output per year

A Comparison of Health-related Quality of Life in Chronic Intestinal Failure and End-Stage Kidney Disease: A Cross-Sectional Study

Research output : Contribution to journal › Journal article › Research › peer-review

• Health-related Quality of Life 100%
• End-stage Kidney Disease 100%
• Chronic Intestinal Failure 100%
• Quality of Life 100%
• Cross-Sectional Study 100%

A cross-sectional study on the impact of educational status on physical activity level in Danish and English adults with type 1 diabetes

• Type I Diabetes 100%
• Type 1 Diabetes Mellitus (T1DM) 100%
• Physical Activity Level 100%
• Educational Status 100%

Advocating for inclusive respiratory syncytial virus vaccine trials to address health disparities

• Licensing of medicines
• Authorisation procedures
• Company authorisations and registrations
• Supervision and inspection
• What is a clinical trial?
• Questions and answers
• Regulation for Clinical Trials
• Substantial modifications
• Assessment times
• GMP and Quality of IMP
• Non-clinical regulatory advice
• Safety reporting during clinical medicinal trials
• Transition of clinical trials from Directive to Regulation
• Fees for clinical trials
• Combined studies with a clinical trial and a simultaneous performance study
• Decentralised Clinical Trials
• Ongoing clinical trials under the Directive
• End of trials with medicinal products and reporting of results
• Trials in animals
• GCP inspection
• Publications
• How to evaluate evidence of the efficacy of medicines
• Evaluation of reviews
• Report suspected illegal activities
• Falsified medicines
• Compassionate use
• Medicine or not
• Export certificates
• Name/address changes
• Relationships
• Financial support
• Medicinal Products Committee
• Side effects of medicines
• Additional monitoring
• News on pharmacovigilance
• Biological and biosimilar medicinal products
• Safety updates
• Post Authorisation Safety Study
• Direct Healthcare Professional Communication
• Adverse events
• Drug interaction
• Pharmacovigilance Council
• Find medicines
• General reimbursement
• Individual reimbursement
• Calculate reimbursement
• Medicines bought in another EU/EEA country
• Reimbursement Committee
• Prices of medicines
• Product numbers
• Central Reimbursement Register
• Reimbursable nutritional products
• Sale outside pharmacies
• Over-the-counter medicines
• Substitution
• Medicines imported from abroad
• Buying and selling medicines online
• Sale of medicines or food supplements online
• Doctors buying medicines for use in their own practices
• Report suspected illegal sale of medicines
• Prescriptions from another country
• New regulations
• COVID-19 antigen test for self-test
• Advice to consumers on buying face masks
• New Tech – new technological possibilities and medical devices
• Patient safety and safe medical devices
• Development of medical devices
• Regulatory advice for medical device companies
• Incident reporting
• Notified bodies
• Registration and marketing
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Conducting well-designed and safe clinical trials is essential for building knowledge about medicines and is a key part of approving new, effective and safe medicines. In addition, clinical trials play a vital role in creating an attractive and competent environment for pharmaceutical development and research in Denmark. Clinical trials provide early insight into new medical treatments in the healthcare system, which builds competence and most importantly benefits patients by giving them quick access to new innovative treatments. Our Clinical Trials Unit is dedicated to improving the clinical trial framework in Denmark and the EU in collaboration with stakeholders from across the ecosystem, always with the best interests of patients in mind. Our focus is to deliver timely and high-quality reviews while developing guidance to support the conduct of clinical trials of the future. You can read more about what a clinical trial is here.

Denmark must be in the lead in early phase research

We have an eye for the entire pharmaceutical development process, but believe that Denmark has the potential to excel in the development of new trial designs, trials with more complex medicines related to rare diseases or personaliced medicines, and early phase research, including 'First in Human' (FIH) trials. This is partly due to Denmark's skilled and specialised researchers and Denmark's many technological opportunities. Early phase trials give Danish patients access to the latest therapies and builds a crucial knowledge capacity among both authorities and researchers. This is expected to have a knock-on effect in the later phases of pharmaceutical development. We are continuously working on initiatives to support early research. We have strong capabilities to support the transition from toxicology studies to clinical trials and offer scientific advice on toxicological, clinical and regulatory issues. In addition, work is underway to re-establish the expedited review of phase I trials under the Clinical Trials Regulation.

The Danish experience makes a difference in Europe

We have a high level of representation and activity in working groups under the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA). In 2024, we have special focus on implementation/optimization of processes under the new EU regulation and the interface between the development of medical devices and medicines.

Increased focus on non-reporting, including trial completion and publication of results

In 2023, we highlighted non-reporting in clinical trials with a stringent process for reminders that can ultimately lead to a police report. Fortunately, there was no need to do so, as we managed to rectify the cases through dialog with the sponsors who failed to make the legally required reports. There has been a significant improvement and we will continue this focus in 2024 to ensure patient safety and transparency of trial results, which is critical for both the research community and patients.

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• Danish Center for Health Services Research
• The Faculty of Medicine
• Department of Clinical Medicine

Selma Lagerløfs Vej 249

9260 Gistrup

Organisation profile

The Danish Center for Health Services Research is a newly established multidisciplinary center that unites the Danish Center for Clinical Health Services Research and the Danish Center for Healthcare Improvements.

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• Atrial Fibrillation Medicine and Dentistry 100%
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Collaborations from the last five years

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Muath Alobaida

Person: TAP

Hanna Maribel Andersen

Charlotte Brix Andersson

• Aalborg University Hospital
• Department of Gynaecology and Obstetrics

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Forecasting Attention Deficit Hyperactivity Disorder Psychiatric Care Capacity Demand

Grøntved, S. , Valentin, J. B. , Johnsen, S. P. , Jensen, C. M. & Mainz, J.

15/09/2021 → 14/09/2024

Project : Research

• Psychiatric Care 100%
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• Mental Health Care 100%

Developing a patient-centered intervention for patients with Transient Ischemic Attack by exploring prognosis and impact on everyday life

Ebbesen, B. H. , Rathleff, M. S. , Modrau, B. , Andreasen, J. & Johnsen, S. P.

01/03/2021 → 01/03/2025

Project : PhD Project

• Transient Ischemic Attack 100%
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Social Inequality in Helath Care

Frydenlund, J. K. S.

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• 659 Journal article
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Research output per year

2024 Chinese Expert Consensus Guidelines on the Diagnosis and Treatment of Atrial Fibrillation in the Elderly, Endorsed by Geriatric Society of Chinese Medical Association (Cardiovascular Group) and Chinese Society of Geriatric Health Medicine (Cardiovascular branch): Executive Summary

Research output : Contribution to journal › Review article › peer-review

• Expert Consensus Guidelines 100%
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• Chinese Expert Consensus 100%

Accumulated β-catenin is associated with human atrial fibrosis and atrial fibrillation

Research output : Contribution to journal › Journal article › Research › peer-review

• Adenomatous Polyposis Coli 100%
• Atrial Cardiomyocytes 100%
• Pathological Analysis 100%
• Mouse Cells 100%

Adherence and Persistence to Antiplatelet Therapy in Lower Extremity Peripheral Arterial Disease: A Danish Population Based Cohort Study

• Danish Population 100%
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• Antiplatelet Therapy 100%
• Peripheral Arterial Disease 100%
• Lower Extremity Arterial Disease 100%

Standard vs. targeted oxygen therapy prehospitally for chronic obstructive pulmonary disease (STOP-COPD): study protocol for a randomised controlled trial

Jensen, A. S. R. (Creator), Valentin, J. B. (Creator), Mulvad, M. G. (Creator), Hagenau, V. (Creator), Skaarup, S. H. (Creator), Johnsen, S. P. (Creator), Væggemose, U. (Creator) & Gude, M. F. (Creator), Figshare, 2024

DOI : 10.6084/m9.figshare.c.7044310.v1 , https://springernature.figshare.com/collections/Standard_vs_targeted_oxygen_therapy_prehospitally_for_chronic_obstructive_pulmonary_disease_STOP-COPD_study_protocol_for_a_randomised_controlled_trial/7044310/1

DOI : 10.6084/m9.figshare.c.7044310 , https://springernature.figshare.com/collections/Standard_vs_targeted_oxygen_therapy_prehospitally_for_chronic_obstructive_pulmonary_disease_STOP-COPD_study_protocol_for_a_randomised_controlled_trial/7044310

Early Economic Assessment of Faecal Microbiota Transplantation for Patients with Urinary Tract Infections Caused by Multidrug-Resistant Organisms

Baek, O. D. (Creator), Hjermitslev, C. K. (Creator), Dyreborg, L. (Creator), Baunwall, S. M. D. (Creator), Høyer, K. L. (Creator), Rågård, N. (Creator), Hammeken, L. H. (Creator), Povlsen, J. V. (Contributor), Ehlers, L. H. (Creator) & Hvas, C. L. (Creator), Adis Journals, 2023

DOI : 10.6084/m9.figshare.22341232.v1 , https://adisjournals.figshare.com/articles/media/Early_Economic_Assessment_of_Faecal_Microbiota_Transplantation_for_Patients_with_Urinary_Tract_Infections_Caused_by_Multidrug-Resistant_Organisms/22341232/1

International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Europe 2019 Poster price

Christensen, Elisabeth (Recipient) & Ehlers, Lars Holger (Recipient), 5 Nov 2019

Prize : Conference prizes

Reizenstein Award for Best Paper in 2017

Ehlers, Lars Holger (Recipient), 30 Sept 2018

Prize : Research, education and innovation prizes

Årets Underviser 2016 ved studienævnet for medicin

Hansen, Louise (Recipient), Dec 2016

Prize : Educational prizes

• 18 Peer review of manuscripts
• 14 Conference presentations
• 13 Conference organisation or participation
• 10 Consultancy
• 10 Talks and presentations in private or public companies
• 9 Public Sector Consultancy
• 9 Membership of review committee
• 8 Membership of committees, commissions, boards, councils, associations, organisations, or similar
• 6 Organisation or participation in workshops, courses, seminars, exhibitions or similar
• 2 Journal editor
• 2 External examination
• 2 Board duties in companies, associations, or public organisations
• 1 Membership of research networks or expert groups
• 1 Visiting another research institution

Activities per year

oplæg i Lifs Arbejdsgruppe om Medicinrådet

Lars Holger Ehlers (Lecturer)

Activity : Talks and presentations › Talks and presentations in private or public companies

Formand for bedømmelsesudvalg, lektorat i sundhedsøkonomi AAU

Lars Holger Ehlers (Other)

Activity : Other

Bedømmelse af PhD afhandling ved SDU

Lars Holger Ehlers (Internal examiner)

Activity : Examination › External examination

Press/Media

Debat: man kan danse sig til bedre trivsel.

Søren Valgreen Knudsen

17/07/2024 → 18/07/2024

2 Media contributions

Press/Media : Press / Media

Debat: Grøn energi er kulsort

Henrik Møller

2 items of Media coverage

Debat: Mennesker med psykisk lidelse dør alt for tidligt

Søren Paaske Johnsen

1 item of Media coverage

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The Contract Research Map is owned and maintained by Scientist.com. It was created to help researchers in the life sciences identify and connect with contract research organizations (CROs) based on geography. Updated nightly, this map features all of the available CROs within our network, so you can order services with a few clicks. Click on a specific country, scroll on the map itself or type into the search bar at the top—there are many ways to find the location and suppliers that you’re looking for. From Argentina to New Zealand, use this map to connect with a CRO near you.

We believe that every researcher across the world should be able to connect with the thousands of global CROs that exist and have the opportunity to work together. Like many industries,the life science supply chain has been disrupted over the last year. But there are many other circumstances such as international customs regulations or sensitive shipping times that create limitations around which countries are feasible to partner with. Sometimes, finding a CRO based in a country that best suits your research needs is imperative. We hope this contract research map allows you to find the right partner in the right place at the right time.

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Trial Nation – one point entry to clinical trials in Denmark

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Denmark: the right place in Europe for clinical trials

All the right conditions.

Access to unique health data, excellent researchers and much more, makes Denmark a very attractive place for international pharmaceutical companies wanting to conduct clinical research and trials.

Denmark is an increasingly attractive location for businesses that depend on clinical trials. In recent years, the various Danish governments have taken active steps to boost the life sciences industry by building further on the strong national healthcare system and world-class environment for business and science. This also includes a keen political focus on improving the framework conditions for conducting clinical trials in Denmark. 

To make it easier and more attractive for global companies to conduct clinical trials in Denmark, a single entry point named Trail Nation has been established. The services of Trial Nation includes: Investigator identification, a coordinated feasibility process with a national response from hospital sites within a few days, estimation of patient numbers eligible for a specific trial and access to established partnerships with hospitals, scientists and patient networks – all free of charge.

Learn about more reasons why Denmark is a great location for your clinical trials in this fact sheet.

Why conduct clinical trials and research in Denmark?

A keen political commitment to the life sciences industry, one of the strongest economies in europe, ranked no. 1 for ease of doing business, continuous optimisation of clinical trial processes and procedures, highly qualified and motivated workforce with many master’s degrees and phd graduates, access to biobanks and registries of patient data, high willingness in the population to participate.

"The innovative and government supported Trial Nation network provides good access to high quality professionals conducting early phase clinical trials. Possibility for national recruitment, good data quality, fast start up times and reliable approval processes creates a very attractive environment for clinical trials which have supported our clinical trial operations strategy significantly." Lise Warming, Country Medical Head Denmark Novartis

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Clinical Research Coordinator (Contractor)

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We are seeking a clinical research coordinator (CRC) to join the Clinical Genetics Branch (CGB) of the Division of Cancer Epidemiology and Genetics (DCEG) at the National Cancer Institute (NCI). The CRC fills a critical role for the interprofessional research team, ensuring compliance with protocol and overall clinical objectives and managing priorities to ensure accurate data collection/entry, data systems management, and data reporting for clinical protocols.  

Major responsibilities include:

• Participate in study coordination and ensure that study activities follow established protocols and Standard Operating Procedures (SOPs), and utilize approved forms, templates and practices. 
• Enter data into research databases, systems, and applications for ongoing studies. 
• Assist the research team with extrapolation, entry, cleaning, and overall quality assurance of incoming and historical data.
• Assist with managing and retrieving data from the Clinical Research Information System at the NIH Clinical Center, dissemination of surveys, and data collection from participants.
• Assist with managing submissions for branch protocols to the Institutional Review Board (IRB), ensuring compliance with IRB requirements and deadlines, and maintaining regulatory files and documentation.
• Format and enter data into spreadsheets and online platforms to analyze information and create reports.
• Assist researchers with developing, completing, and maintaining study data collection forms and source documents.
• Document, collect, record, and retain all research-related participant encounters including in-person, phone, or electronic in the research record (e.g., source documents, case report forms) according to regulations, guidelines, and institution-specific policies, thus ensuring good documentation practices. 

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Aixial Group adopts Medidata’s platform to consolidate clinical trial data

France-based clinical research company Aixial Group is consolidating clinical data from one of its business units into Medidata’s digital platform, according to a Sept. 3 release .

The partnership will allow Aixial to support patient data privacy, monitor throughout studies and make better-informed decisions, the release said.

Aixial works with trial sponsors to develop oncology, cell and gene, and rare disease therapies. 

“Consolidating clinical data onto the Medidata Platform will power the experience and expertise of our teams to deliver this superior service for our customers,” Aixial Chief Technology Officer Tim Corbett-Clark said in the release.

By bringing data into Medidata’s platform, Aixial will create what’s known as a single source of truth , meaning that the company’s data will be accessible from one digital location. Having data readily available in a single place can speed up decision-making and improve cybersecurity.

Medidata also had another buyer for its technology recently: Japanese Big Pharma Eisai . In that partnership, Eisai is incorporating Medidata’s data studio into its own clinical trial management platform.

• Introduction
• Conclusions
• Article Information

eTable 1. Classification of Indications

eTable 2. Dechallenge and Rechallenge With Semaglutide

eTable 3. Dechallenge and Rechallenge With Liraglutide

eTable 4. Sex, Median Age and Dose (IQR) for Suicidal Ideation ADRs by Drug and Indication

eTable 5. Coreported Psychiatric Reactions for Semaglutide

eTable 6. Coreported Psychiatric Reactions for Liraglutide by Indication

eTable 7. Number of Cases, Noncases, Other Adverse Drug Reactions (ADRs) and Total Number of Other Reports in the Database for Semaglutide

eTable 8. Number of Cases, Noncases, Other Adverse Drug Reactions (ADRs) and Total Number of Other Reports in the Database for Liraglutide

eTable 9. Disproportionality Analysis of Semaglutide-Associated Suicidal Ideation Compared With All Other Drugs in the Database in Female and Male Patients Separately

eTable 10. Number of Semaglutide-Associated Cases of Adverse Drug Reactions (ADRs) by Year

eTable 11. Number of Liraglutide-Associated Cases of Adverse Drug Reactions (ADRs) by Year

eReferences.

Data Sharing Statement

• GLP-1 Receptor Agonists and Suicidality JAMA Network Open Invited Commentary August 20, 2024 Francesco Salvo, MD, PhD; Jean-Luc Faillie, MD, PhD

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Schoretsanitis G , Weiler S , Barbui C , Raschi E , Gastaldon C. Disproportionality Analysis From World Health Organization Data on Semaglutide, Liraglutide, and Suicidality. JAMA Netw Open. 2024;7(8):e2423385. doi:10.1001/jamanetworkopen.2024.23385

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Disproportionality Analysis From World Health Organization Data on Semaglutide, Liraglutide, and Suicidality

• 1 The Zucker Hillside Hospital, Department of Psychiatry, Northwell Health, Glen Oaks, New York
• 2 Department of Psychiatry, Zucker School of Medicine at Northwell/Hofstra, Hempstead, Glen Oaks, New York
• 3 Department of Psychiatry, Psychotherapy and Psychosomatics, Hospital of Psychiatry, University of Zurich, Zurich, Switzerland
• 4 Institute of Pharmaceutical Sciences, Department of Chemistry and Applied Biosciences, ETH Zurich, Zurich, Switzerland
• 5 Institute of Primary Care, University of Zurich and University Hospital Zurich, Zurich, Switzerland
• 6 WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, Verona, Italy
• 7 Pharmacology Unit, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy
• 8 Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland
• Invited Commentary GLP-1 Receptor Agonists and Suicidality Francesco Salvo, MD, PhD; Jean-Luc Faillie, MD, PhD JAMA Network Open

Question   Are glucagon-like peptide-1 receptor agonists semaglutide and liraglutide, which were originally introduced for the treatment of type 2 diabetes and are frequently prescribed due to their weight loss properties, associated with disproportionately increased reporting of suicidality?

Findings   This disproportionality analysis through the case-control design based on the World Health Organization global database collecting suspected adverse drug reactions, identified a disproportionality signal of suicidal ideation with semaglutide, which remained significant when comparing semaglutide with dapagliflozin and metformin and in the subgroup of patients with coreported use of antidepressants and benzodiazepines.

Meaning   A detected signal of semaglutide-associated suicidal ideation warrants urgent clarification.

Importance   Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have gained use primarily due to their weight-reduction effects, although a regulatory review was undertaken for potential suicidality concern.

Objectives   To evaluate potential signals for suicidal and self-injurious adverse drug reactions (ADRs) associated with the GLP-1 RAs semaglutide and liraglutide.

Design, Setting, and Participants   Disproportionality analysis through the case-control design using the World Health Organization (WHO) global database of suspected ADRs. Participants were clinical patients worldwide experiencing an ADR suspectedly attributable to semaglutide or liraglutide in the database from inception to August 30, 2023. Data were analyzed from September to December 2023.

Exposure   Treatment with semaglutide or liraglutide regardless of indication or treatment duration.

Main Outcomes and Measures   Reporting odds ratio (ROR) and the bayesian information component (IC) with 95% CIs were calculated as measures of disproportionate reporting of suicidal and self-injurious ADRs associated with semaglutide and liraglutide compared with all other medications. Sensitivity analyses were conducted including patients with coreported use of antidepressants and benzodiazepines and using dapagliflozin, metformin, and orlistat as comparators. A disproportionality signal was considered when the lower limits of the ROR and IC were above 1 and 0, respectively.

Results   A total of 107 (median [IQR] age 48 [40-56] years; 59 female patients [55%]) and 162 (median [IQR] age 47 [38-60] years; 100 female patients [61%]) cases of suicidal and/or self-injurious ADRs were reported between November 2000 and August 2023 with semaglutide and liraglutide, respectively. Significant disproportionality was detected only for semaglutide-associated suicidal ideation (ROR, 1.45; 95% CI, 1.18-1.77; IC, 0.53; 95% CI, 0.19-0.78), which remained significant in patients with coreported use of antidepressants (ROR, 4.45; 95% CI, 2.52-7.86; IC, 1.96; 95% CI, 0.98-2.63) and benzodiazepines (ROR, 4.07; 95% CI, 1.69-9.82; IC, 1.67; 95% CI, 0.11-2.65), when compared with dapagliflozin (ROR, 5.56; 95% CI, 3.23-9.60; IC, 0.70; 95% CI, 0.36-0.95), metformin (ROR, 3.86; 95% CI, 2.91-5.12; IC, 1.20; 95% CI, 0.94-1.53) and orlistat (ROR, 4.24; 95% CI, 2.69-6.69; IC, 0.70; 95% CI, 0.36-0.95).

Conclusions and Relevance   This study using the WHO database found a signal of semaglutide-associated suicidal ideation, which warrants urgent clarification.

Over the past decade, obesity trends have reached epidemic standards. 1 In this context, the understanding of glucagon-like peptide-1 (GLP-1)–based mechanisms and related anorectic properties of GLP-1 receptor agonists (RAs) have revolutionized the treatment of obesity. 2 In addition to enhancing glucose-dependent insulin release, GLP-1 RAs may reduce glucagon secretion as well as gastric emptying. 2 Originally introduced for the treatment of type 2 diabetes, the effect of GLP-1 RAs on weight loss soon caught research attention. 3 The weight loss properties of liraglutide and semaglutide quickly went viral on social media, leveraging their promotion as lifestyle drugs not just for patients with diabetes 4 and leading to a global shortage. 5 Currently, it is estimated that approximately 10% of patients with type 2 diabetes in the US are prescribed GLP-1 RAs. 6 Accordingly, regulatory authorities over the world have urged health care professionals to direct available supplies to patients with type 2 diabetes who are inadequately managed with other medications over off-label prescriptions. 7 , 8 Despite the promising potential of GLP-1 RAs, serious concerns have been raised about their safety. 9 , 10 On July 3, 2023, a series of reports for suicidal or self-harming thoughts associated with liraglutide or semaglutide triggered an ongoing review by the European Medicines Agency (EMA). 11 Previously, in the approval trials, 9 of the 3384 patients treated with liraglutide (0.27%) had reported suicidal ideation compared with 2 of 1941 patients allocated to the placebo group (0.10%). 12 On the other hand, no patients using semaglutide for obesity had developed suicidal ideation, 13 , 14 and no mental health differences were observed in adolescents, with a lower percentage of participants in the semaglutide group than in the placebo group reporting psychiatric adverse events (7% vs 15%). 15

The EMA-led investigation might have a global impact, given that liraglutide and semaglutide are administered to more than 20 million people per year. 11 This investigation was expected to be completed in November 2023, but ultimately updated in April 2024 after requesting further clarifications. 16 In the meantime the British Medicines and Healthcare Products Regulatory Agency and the US Food and Drug Administration (FDA) also announced a similar investigation. 17 So far both EMA and FDA declared that they did not find any clear demonstration of a relationship between GLP-1 RAs and suicide based on the available evidence, although the FDA investigation is still ongoing. 18 , 19

Marketing companies stated that warnings about suicidal behavior and ideation are formally required for medications prescribed for chronic weight management affecting the central nervous system. 20 The first 2 pharmacovigilance studies on the topic only included partial data from the US, 21 , 22 and a report from the EMA pharmacovigilance database did not assess disproportionality. 23 Typically, patients with suicidality are excluded from clinical trials; therefore, the reports from clinical trials may be less precise in capturing the risk of suicidal or self-injurious adverse drug reactions (ADRs) in later practice. In this context, we aimed to assess suicidal and/or self-injurious ADRs associated with liraglutide or semaglutide at a global level, using a World Health Organization (WHO) database of individual case safety reports (ICSRs).

This case-control study was conceived as a disproportionality analysis of the WHO Vigibase, a consolidated tool for postmarketing surveillance. In the past, large-scale ICSR databases attracted interest for early detection and characterization of emerging safety issues. 24 - 26

All procedures and analyses adhered to the Uppsala Monitoring Centre (UMC) caveat agreement for reporting standards and were in accordance with the Helsinki declaration for ethical principles in medical research. As the data were anonymized and all analyses were descriptive, an ethical review from the Zurich Cantonal ethics board was not required. Additionally, per the Common Rule, because all data in the database are anonymized, patient informed consent was not required. This study was reported according to The Reporting of A Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV) guideline. 27 - 29

We conducted a comprehensive search for reports of suicidal or self-injurious ADRs associated with liraglutide and semaglutide within the WHO global ICSRs database, which is the largest pharmacovigilance archive worldwide containing over 28 million reports of suspected ADRs from 140 member countries. On August 30, 2023, we selected all deduplicated ICSRs recorded in the database from inception. Reports for semaglutide were recorded between July 2011 and August 2023, whereas for liraglutide, reports were collected between November 2000 and August 2023. Database services are offered by the UMC, which manages the database. 30 , 31 Drugs recorded on the reports are coded using the WHO drug dictionary 32 and ADRs are classified according to the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1. 33 Two authors (C.G. and G.S.) identified ADRs involving liraglutide and/or semaglutide as suspected or interacting drugs to identify any report of suicidal and/or self-injurious ADRs as classified in the “suicide/self-injury” standardized MedDRA query (SMQ) of the MedDRA classification. Such SMQs include any ADR related to suicidal and/or self-injurious thoughts and events. 34 Cases were all reports of suicidal and/or self-injurious ADRs, whereas controls were all other reports of suspected ADRs. We included liraglutide-related or semaglutide-related reports.

Descriptive statistics on demographic and clinical characteristics (in medians and IQRs) of reported cases were provided. We compared the percentage of female patients, age, and dose between patients prescribed GLP-1 RAs for different indications. We grouped indications into the following categories: diabetes, weight management, possible off-label indication, and others. The classification of indications is detailed in eTable 1 in Supplement 1 . Comparisons of demographic and clinical characteristics were performed using χ 2 tests, Wilcox, Kruskal-Wallis, or Fisher tests. We also explored psychiatric symptoms coreported with the suicidal and/or self-injurious ADRs of interest. Two-sided P values less than .05 were considered significant.

We performed disproportionality analysis using 2 consolidated measures when at least 3 reports were recorded: first, we estimated reporting odds ratio (ROR) 35 and the bayesian information component (IC), 36 with 95% CIs. We applied well-established thresholds to define signals of disproportionate reporting, that is, lower limit of the 95% CI greater than 1 and greater than 0 for ROR and IC, respectively. Additional details about disproportionality analysis are reported in the eMethods in Supplement 1 .

For suicidal and/or self-injurious ADRs that had a signal of disproportionate reporting in the main disproportionality analysis, we performed sensitivity analyses to explore potential confounders. The following sensitivity analyses were conducted: (1) selecting only cases with coreporting of use of antidepressants and (2) only cases with coreporting of use of benzodiazepines as a proxy of depressive and anxiety disorders that can increase the risk of suicidal and/or self-injurious behaviors and ideation. Moreover, we repeated the aforementioned analyses by (3) excluding reports with coreporting of antidepressants and (4) benzodiazepines. To additionally mitigate the risk of confounding by indication and channeling bias, we performed 3 other sensitivity analyses using other drugs prescribed for the same indications (obesity and type 2 diabetes) as comparators; specifically we selected (5) dapagliflozin, a sodium-glucose cotransporter 2 inhibitor, and (6) metformin, considering their well-established role in the treatment of type 2 diabetes coupled with their favorable impact on body weight 37 , 38 ; and (7) orlistat, considering its indication for obesity and weight loss.

We also assessed the disproportionality of reporting in female and male patients separately. Last, to assess the trend of reporting over time, we reported the number of reports by year for all ADRs of interest and for each ADR with disproportionate reporting. Data were analyzed from September to December 2023.

As of August 30, 2023, of the 36 172 078 total reports in the database, we identified a total of 107 (median [IQR] age, 48 [40-56] years; 59 female patients [55%]; median [IQR] treatment duration, 24.0 [2.3-61.0] days [data from 28 reports]) unique, deduplicated cases of suicidal and/or self-injurious ADRs associated with semaglutide (107 of the 30 527 total reports [0.35%]) and 162 (median [IQR] age, 47 [38-60] years; 100 female patients [61%]; median [IQR] treatment duration, 46.0 [14.0-99.0] days [data from 33 reports]) cases associated with liraglutide (162 of 52 131 total reports [0.31%]). Demographic and clinical characteristics of the cases are reported in Table 1 by GLP-1 RA.

Regarding indications for use, the main reason for prescription was a possible off-label use (34 patients for semaglutide [31.8%] and 55 for liraglutide [33.9%]), followed by weight management (28 for semaglutide [26.2%] and 40 for liraglutide [24.7%]), diabetes (26 for semaglutide [24.3%] and 33 for liraglutide [20.4%]), and in 1 case for polycystic ovary syndrome for each GLP-1 RA (1 for semaglutide [0.9%] and 1 for liraglutide [0.6%]). Semaglutide-associated cases were reported by consumers in almost half of the reports (52 cases [48.6%]). Liraglutide-associated cases were mainly reported by health professionals (103 cases [63.6%]).

Regarding outcomes following dechallenge and rechallenge, both for semaglutide (eTable 2 in Supplement 1 ) and liraglutide (eTable 3 in Supplement 1 ), suicidal ideation resolved after drug discontinuation in 62.5% of the cases. In the semaglutide-associated reports of suicidal and/or self-injurious ADRs, the most common comedications included antidiabetics (17 patients [15.9%]) and antidepressants (14 patients [13.1%]), with higher percentages for liraglutide (49 patients [30.3%] and 30 patients [18.5%], respectively) ( Table 1 ).

Suicidal and/or self-injurious ADRs associated with semaglutide and/or liraglutide are presented in Table 2 . Suicidal ideation, intentional overdose, and suicide attempt ranked highest for semaglutide (94 patients [88%], 7 patients [6.5%], and 7 patients [6.5%], respectively), whereas for liraglutide suicidal ideation, completed suicide, and suicide attempt ranked highest (116 patients [71.6%], 19 patients [11.7%], and 16 patients [9.9%], respectively). Seven reactions (6.5%) were fatal for semaglutide and 24 (14.8%) for liraglutide. In Table 2 we report the number and percentage of each ADR by indication. For reports of suicidal ideation, we reported older age for patients prescribed liraglutide for diabetes compared with off-label and weight management, as well as a lower percentage of female patients prescribed liraglutide for diabetes compared with off-label and weight management (eTable 4 in Supplement 1 ).

The list of coreported psychiatric symptoms for semaglutide and liraglutide is reported in eTable 5 and eTable 6 in Supplement 1 . For liraglutide there were 91 cases in which suicidal and/or self-injurious ADRs were reported without any other psychiatric symptoms, 50 cases in which 1 psychiatric symptom was coreported, and 21 in which 2 or more other psychiatric symptoms were reported. Table 2 shows the number of cases in which suicidal and/or self-injurious ADRs were reported alone by indication. In half of these cases the drug was taken off-label both for semaglutide and liraglutide ( Table 2 ).

We detected a significant disproportionality only for semaglutide-associated suicidal ideation compared with all medications (ROR, 1.45; 95% CI, 1.18-1.77; IC, 0.53; 95% CI, 0.19-0.78) ( Table 3 ). Data on duration for semaglutide treatment were available in 26 patients reporting suicidal ideation, with a mean (range) duration of 80.39 (0 to 610) days between semaglutide treatment initiation and suicidal ideation occurrence. We did not find signals for any other ADR of interest ( Table 3 ). Numbers of cases and controls are reported in eTable 7 and eTable 8 in Supplement 1 .

The first sensitivity analysis including cases with comedications with antidepressants showed a disproportionate reporting of semaglutide-associated suicidal ideation compared with all medications (ROR, 4.45; 95% CI, 2.52 to 7.86; IC, 1.96; 95% CI, 0.98 to 2.63). The second sensitivity analysis including cases with comedications with benzodiazepines showed a disproportionate reporting of semaglutide-associated suicidal ideation compared with all medications (ROR, 4.07; 95% CI, 1.69 to 9.82; IC, 1.67; 95% CI, 0.11 to 2.65). Reporting was not disproportionate when excluding reports with comedications with antidepressants (ROR, 1.28; 95% CI, 1.03 to 1.60; IC, 0.36; 95% CI, −0.10 to 0.63), but remained disproportionate when excluding reports with comedications with benzodiazepines (ROR, 1.40; 95% CI, 1.13 to 1.72; IC, 0.48; 95% CI, 0.13 to 0.73). The fifth sensitivity analysis showed a disproportionate reporting of semaglutide-associated suicidal ideation compared with dapagliflozin (ROR, 5.56; 95% CI, 3.23 to 9.60; IC, 0.70; 95% CI, 0.36 to 0.95). The sixth sensitivity analysis showed a disproportionate reporting of semaglutide-associated suicidal ideation compared with metformin (ROR, 3.86; 95% CI, 2.91 to 5.12; IC, 1.20; 95% CI, 0.94 to 1.53). The seventh sensitivity analysis showed a disproportionate reporting of semaglutide-associated suicidal ideation compared with orlistat (ROR, 4.24; 95% CI, 2.69 to 6.69; IC, 0.70; 95% CI, 0.36 to 0.95). The analysis of disproportionality for suicidal ideation in female and male patients separately yielded disproportionate reporting in men (ROR, 1.51; 95% CI, 1.09 to 2.08; IC, 0.58; 95% CI, 0.03 to 0.97), whereas in female patients, although the lower limit of the 95% CI of the ROR was greater than 1 (ROR, 1.35; 95% CI, 1.02 to 1.77) the lower limit of the 95% CI of the IC was less than 0 (IC, 0.42; 95% CI,−0.05 to 0.75) (eTable 9 in Supplement 1 ).

From marketization year till August 2023, there was a slight increase in the proportion of suicidal ADRs reported for both drugs. The increase was from 0% (2017) to 0.8% (2023) for semaglutide and from 0.09% (2014) to 0.4% (2023) for liraglutide (eTable 10 and eTable 11 in Supplement 1 ).

In this disproportionality analysis of the world’s largest ICSRs database using a case-control design, we found a significant disproportionality only for semaglutide-associated suicidal ideation compared with other medications. The number of reports showed a gradual increase over the years, which may indicate a widening therapeutic scope in obesity and accumulating clinical experience.

To our knowledge, no previous reports investigated the association between semaglutide and suicidal ideation using this database. In our sensitivity analyses, the disproportionality remained significant when focusing on coreported antidepressants or benzodiazepines, suggesting that people with anxiety and depressive disorders may be at higher probability of reporting suicidal ideation when medicated with semaglutide. When repeating the analysis after excluding cases in which antidepressants were coreported, we did not detect a disproportionality signal. In contrast, when repeating the analysis after excluding cases in which benzodiazepines were coreported, the disproportionality remained significant. This is consistent with an interaction between baseline psychopathology and semaglutide effects and warrants further investigation. Although EMA stated that no update to the product information is warranted, based on these findings, we believe that a precaution of use in patients with psychiatric disorders or psychological lability could be added in the semaglutide package insert. Remarkably, the FDA label of semaglutide for obesity warned to monitor for depression or suicidal thoughts. 39

One study using the FDA pharmacovigilance database suggested disproportionate reporting for suicidal ideation and suicidal depression for semaglutide and liraglutide, 21 whereas another study did not detect an association between suicidality and GLP-1 RAs. 22 Likewise, a cohort study using electronic health records did not detect higher risks of suicidal ideation in patients with obesity or diabetes treated with semaglutide compared with non–GLP-1 RAs. 40 Compared with this study, in our analysis we also included patients with potential off-label prescription of GLP-1 RAs. Thus, our analysis may be generalized to patients receiving GLP-1 RAs without a diagnosis of diabetes or obesity, thus further confirming the complementary nature of studies based on ICSRs disproportionality analysis and longitudinal observational design.

Evidence from bariatric studies suggests that a history of depression or anxiety is a predictor of suicide risk postoperatively, providing context for this interplay 41 ; authors discussed this association in light of the emerging frustration due to high expectations of bariatric surgery outcomes in patients with limited resources to deal with mental distress. 41 Of note, the pivotal trials of semaglutide in obesity had different exclusion criteria for mental disorders, such as major depressive disorder within 2 years before screening, diagnosis of severe psychiatric disorders, and history of suicide attempts. 13 , 15 An alternative hypothesis may consider very rapid weight loss related to adjustment problems such as inability to eat as expected and ultimately exacerbated mental distress in highly vulnerable patients. 41 Due to lack of data on GLP-1 RA–related changes of baseline weight or BMI, we could not test for either hypothesis.

Although comorbidity with depression is high in patients with diabetes, 42 the coreporting between antidepressants and antidiabetics was negligible. Furthermore, the signal of semaglutide remained when comparing with dapagliflozin, metformin, and orlistat, mitigating the risk of confounding by indication for diabetes and obesity. Therefore, patients with diabetes and/or obesity without psychiatric comorbidities may not be at high risk of semaglutide-associated suicidal ideation. Although ADR incidence cannot be calculated using the spontaneous reporting system, this ADR is likely to be rare and would probably not substantially alter the benefit-risk profile of semaglutide in approved therapeutic settings. However, the observed high proportion of cases due to possible off-label use and a recently published postmarketing signal of misuse or abuse 43 call for urgent clarification of patient-related and drug-related risk factors; cohort studies and large registries should be stratified by therapeutic indication, sex, and history of mental disorders, and data from off-label use should be retrieved.

Despite the large number of cases, we did not detect any signals for liraglutide-associated suicidal and/or self-injurious ADRs. Pooled data from phase 2 and 3 trials on liraglutide vs placebo for weight management identified a potential risk for suicidal ideation. 12 Nine of 3384 participants in the liraglutide group vs 2 of 1941 in the placebo group reported suicidal ideation or behavior during the trial (0.27% vs 0.10%). 12

The results of this study should be interpreted in light of several limitations. 25 First, we need to consider barriers to reporting and missing information. Second, the well-known inability to infer causality does not allow us to attribute any reactions to the effect of a drug. Third, the lack of denominator does not allow us to estimate the incidence of ADRs. Fourth, selection and collider bias, 44 as well as confounding by indication and channeling bias, although partially mitigated by our sensitivity analyses, may have played a role as people with treatment-resistant diabetes or obesity might reflect a subgroup of patients with more severe conditions including higher risk of mental distress. Additional adjustments for potential confounders, such as alcohol or substance misuse, were limited by the relatively small number of reports found. In the absence of more details about off-label prescribing, we were not able to further qualify the extent to which prescribing was off-label and its impact on the results. Fifth, the lack of treatment outcomes, such as weight change, did not allow different hypotheses to be considered. Sixth, the high proportion of cases with missing data on medication dose precluded a dose-response analysis. Seventh, because of the absence of information on the sociodemographic profile of the reporters, it is impossible to account for volunteer bias. Eighth, it is not possible to exclude the chance that, for instance, suicidal ideation may have preexisted. Ninth, data on treatment duration until ADR were provided only in a small number of reports. Additionally, since disproportionality measures are interdependent, the lack of statistically significant disproportionality should not be automatically interpreted as a safety endorsement. Several factors may influence the reporting pattern and the ability to detect disproportionality, including known and widely reported ADRs such as gastrointestinal ADRs.

Our findings are relevant to the general reader seeking up-to-date information. This relevance arises from the expectation that personal or anecdotal reports may continue to gain popularity on social media platforms without knowledge about risks. 45 One consequence of this trend may be the increase in off-label use of semaglutide, which is a public health concern that has led to the illegal trade in semaglutide pens, some of which are counterfeit. 46 Recently, a public warning about fake counterfeit semaglutide pens was issued in the United Kingdom and the US. 46 , 47 Considering the risk of suicidal ideation in people taking semaglutide off-label, authorities should consider issuing a warning to inform about this risk.

In this disproportionality study of an ADR database, we reported a disproportionality signal of suicidal ideation with semaglutide, but not for liraglutide, particularly among patients with coreported antidepressant use, a proxy for affective disorders (a notable exclusion criteria of premarketing clinical trials).

Accepted for Publication: May 21, 2024.

Published: August 20, 2024. doi:10.1001/jamanetworkopen.2024.23385

Open Access: This is an open access article distributed under the terms of the CC-BY License . © 2024 Schoretsanitis G et al. JAMA Network Open .

Corresponding Author: Georgios Schoretsanitis, MD, PhD, The Zucker Hillside Hospital, Behavioral Health Pavilion, 75-59 263rd St, Glen Oaks, NY 11004 ( [email protected] ).

Author Contributions: Drs Schoretsanitis and Gastaldon had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: All authors.

Acquisition, analysis, or interpretation of data: Schoretsanitis, Weiler, Raschi, Gastaldon.

Drafting of the manuscript: Schoretsanitis, Gastaldon.

Critical review of the manuscript for important intellectual content: All authors.

Statistical analysis: Schoretsanitis, Gastaldon.

Administrative, technical, or material support: Barbui.

Supervision: Schoretsanitis, Barbui, Raschi.

Conflict of Interest Disclosures: Dr Schoretsanitis reported receiving personal fees from HLS, Dexcel, Saladax, and Thermo Fisher outside the submitted work. Dr. Weiler reported being a member of the Human Medicines Expert Committee of Swissmedic. No other disclosures were reported.

Disclaimer: The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties. While the authors used data from VigiBase, the World Health Organization (WHO) global database of individual case safety reports, as a source of information, the conclusions do not represent the opinion of the Uppsala Monitoring Centre (UMC) or the WHO.

Data Sharing Statement: See Supplement 2 .

Additional Contributions: The authors acknowledge the UMC, which provided and gave permission to use the data analyzed in the present study. The authors are also indebted to Dr Leonie Heron, PhD, Institute for Social and Preventive Medicine, University of Bern, Bern, Switzerland, who helped in editing this article. She was not compensated for her services.

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The role of patient organizations in shaping research, health policies, and health services for rare genetic diseases: the dutch experience, 1. introduction, aims and objectives, 2. materials and methods, 2.1. key methods, 2.2. material, 3.1. the beginning—a father’s story, 3.2. challenges of living with a rare genetic disease: unmet needs and founding a parent/patient organization for neuromuscular diseases.

• Address the knowledge gap and the lack of informed care; provide appropriate, actionable education and information for parents about home care, transportation, technical help, financial help, and recreation; and organize support by setting up mutual help groups for different neuromuscular diseases;
• Promote needs-led research, cooperation, and active involvement in the field of research and in the development of therapies;
• Generate attention and publicity to reach all involved patients and parents and to find financial resources to support (V)SN’s activities.

3.2.1. (V)SN: Early Milestones and Achievements

• Implementing standing working groups to realize home visits for advice by an experienced member plus supplementing telephone consultation to fill home visit gaps;
• Organization of a special symposium aiming at the creation of a professional structural framework for (V)SN;
• Establishing a committee to raise attention for genetic muscular diseases in the medical and scientific communities;
• Organizing regular meetings with medical experts and researchers to facilitate members’ access to state-of-the-art information, to keep members informed and updated on current research projects and on latest research findings, and, last but not least, mentoring medical experts on patients’ needs and advocating needs-led research.

3.2.2. (V)SN Involvement in Orphan Drug Development

• Contacting and lobbying manufacturers to prepare for their assessment of cost-effectiveness and reimbursement procedures in The Netherlands;
• Lobbying the National Health Care Institute (Zorginstituut Nederland) [ 31 ] and the Ministry of Health (VWS) of The Netherlands [ 32 ];
• Educating physicians and researchers with respect to their role in the admission and reimbursement of orphan drugs. (V)SN is committed as well to the management of expectations of patients with regard to gene therapy.

3.2.3. (V)SN: Newborn Screening for Spinal Muscular Atrophy (SMA)

3.2.4. (v)sn today, 3.2.5. neuromuscular diseases internationally united, networking and partnering—from a patients’ initiative to pan-european research institutions: establishing the european alliance of neuromuscular disorders associations (eamda) and the european neuromuscular centre (enmc), 3.3. founding the first national patient umbrella organization for rgds in europe and shaping the infrastructure for genetic services and counseling centres in the netherlands, 3.3.1. shaping and implementing genetic service centres, including genetic counselling centres in the netherlands, 3.3.2. key steps taken by vsop to promote genetic counselling services and to raise public awareness about genetics.

• (i) Raising public awareness, addressing “genetic illiteracy”
• (ii) Capacity building for genetic services

3.3.3. National Umbrella Patient Organizations Internationally United and Partnering

• The development of educational material about next-generation sequencing (“Next generation sequencing in diagnostiek”) for the public, patients, and healthcare providers in collaboration with Erfocentrum [ 100 ];
• Joining of the supervisory board of H2O (Health Outcomes Observatory), a European project financed by both the EU and the European Federation of Pharmaceutical Industries and Associations (EFPIA) [ 101 ]. EFPIA represents the biopharmaceutical industry operating in Europe [ 102 ]. This project is intended to provide insight into clinical data and patient-reported data for patients from different disease areas and healthcare providers via dashboards, for example, for joint decision-making [ 103 ];
• Close involvement—through support to access to empirical data- in the document “Advice from the Health Council of The Netherlands” (Gezondheidsraad) to the government in November 2023 on preconception carrier screening. The Health Council recommends pilot research to determine whether preconception carrier screening could be responsibly offered to all prospective parents in The Netherlands to equip them with the information they need to enable them to make informed reproductive decisions [ 104 ];
• Co-ordinating the input of patients and patient organizations into the Clinical Genetics Knowledge Agenda, which describes the top 10 knowledge gaps in clinical genetic care. The two overarching knowledge questions are: what barriers are in place for healthy family members who are at increased risk of a hereditary condition with treatment options to be referred for genetic counselling and possibly DNA testing, and how can the identified barriers be overcome? The agenda was published at the end of 2022 [ 105 ]. The Netherlands Association of Clinical Geneticists (VKGN) is currently exploring the possibilities for further research to address these knowledge gaps, including input from the patient perspective.
• Participation in the decision-making process to add an NIPT (Non-Invasive Prenatal Test) in April 2023 as a standard option—if the pregnant woman wishes so—in the prenatal screening program of The Netherlands [ 106 ].

4. Where We Are Today, Future Prospects, and Challenges

4.1. challenges, 4.1.1. availability of treatment and costs of cell and gene therapies, 4.1.2. diagnostic odyssey and child mortality, 4.1.3. lack of diversity in genomics studies, 4.2. limitations, 5. epilogue and the lessons i learned, author contributions, institutional review board statement, informed consent statement, data availability statement, acknowledgments, conflicts of interest.

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Share and Cite

Poortman, Y.; Ens-Dokkum, M.; Nippert, I. The Role of Patient Organizations in Shaping Research, Health Policies, and Health Services for Rare Genetic Diseases: The Dutch Experience. Genes 2024 , 15 , 1162. https://doi.org/10.3390/genes15091162

Poortman Y, Ens-Dokkum M, Nippert I. The Role of Patient Organizations in Shaping Research, Health Policies, and Health Services for Rare Genetic Diseases: The Dutch Experience. Genes . 2024; 15(9):1162. https://doi.org/10.3390/genes15091162

Poortman, Ysbrand, Martina Ens-Dokkum, and Irmgard Nippert. 2024. "The Role of Patient Organizations in Shaping Research, Health Policies, and Health Services for Rare Genetic Diseases: The Dutch Experience" Genes 15, no. 9: 1162. https://doi.org/10.3390/genes15091162

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Research trends in the relationship between vitamin D and type 2 diabetes mellitus: a 20-year bibliometric and visualization analysis

1 Department of Endocrinology, Affiliated Wujin Hospital of Jiangsu University, Changzhou, Jiangsu, China

2 Department of Endocrinology, Wujin Clinical College of Xuzhou Medical University, Changzhou, Jiangsu, China

Xuejing Shao

Claudiu Cicea, Bucharest University of Economic Studies, Romania

Associated Data

Publicly available datasets were analyzed in this study. This data can be found here: https://webofscience.clarivate.cn/wos/alldb/basic-search .

Introduction

Vitamin D has a significant correlation with type 2 diabetes. Insufficient levels of vitamin D can cause insulin resistance, which impairs the ability of cells to respond to insulin and worsens the progression of diseases. Furthermore, vitamin D has the potential to enhance the release of insulin, enhance the regulation of blood sugar levels, and reduce the glycemic index. Research has indicated that insufficient levels of vitamin D may elevate the likelihood of experiencing complications related to type 2 diabetes, including cardiovascular disease and neuropathy. This study employed bibliometric analysis to investigate recent advancements in research about the relationship between vitamin D and type 2 diabetes.

We searched for articles on the topic of vitamin D and type 2 diabetes published between January 1, 2004, and December 31, 2023. The search was performed on February 20, 2024, using the Web of Science Core Collection (WoSCC). Utilizing VOSviewer and CiteSpace, we conducted bibliometric analysis and visualization.

A comprehensive study was conducted on a total of 1362 papers pertaining to the relationship between vitamin D and type 2 diabetes. The United States had the biggest number of publications and the highest effect among these articles. Within the top 10 most published journals, the journal “DIABETES CARE” has the highest H-index, indicating its significant influence in this field of study. Currently, there is an extensive body of research on the supplementation of vitamin D for the improvement of type 2 diabetes and prevention of complications in type 2 diabetes, as well as its related mechanisms. Research related to bone turnover and peripheral neuropathy represents a promising area for future studies.

Overall, bibliometrics may assist researchers in comprehending the trajectory, significant themes, and scholarly influence of the field concerning vitamin D and type 2 diabetes. This, in turn, offers substantial backing for future studies that delve further into the subject matter.

1. Introduction

Vitamin D is crucial in the development and progression of type 2 diabetes mellitus and its associated problems. Type 2 diabetes mellitus is a long-term metabolic disorder characterized by insulin resistance and inadequate insulin production, resulting in high levels of glucose in the blood ( 1 ). Insulin resistance is a significant pathological mechanism that occurs in the initial phases of type 2 diabetes. Vitamin D is linked to insulin receptors in both muscle cells and fat cells. Sufficient consumption of vitamin D enhances insulin sensitivity in these cells and decreases insulin resistance ( 2 ). Furthermore, vitamin D has the potential to improve insulin resistance by regulating inflammatory responses and cellular communication pathways ( 3 ). Vitamin D also regulates the release of insulin. Vitamin D receptors have a broad presence throughout the pancreas and are linked to the regulation of insulin release and the functioning of insulin-producing cells. Several studies indicate that sufficient consumption of vitamin D may enhance insulin secretion and enhance glycemic management ( 4 ). The glycemic index is an important factor in the dietary management of individuals with type 2 diabetes since it measures how quickly foods increase blood glucose levels. Consuming vitamin D may potentially decrease the glycemic index of foods, leading to a reduction in blood sugar fluctuations and promoting better regulation of blood sugar levels ( 5 ). Inadequate levels of vitamin D can result in heightened problems associated with type 2 diabetes. For instance, a lack of vitamin D may elevate the likelihood of experiencing consequences such as cardiovascular disease, kidney disease, and neuropathy ( 6 , 7 ). In recent years, there has been significant scientific research conducted on the relationship between vitamin D and type 2 diabetes, yielding positive results. The present study highlights the importance of maintaining adequate levels of vitamin D for the prevention and treatment of type 2 diabetes, offering guidance for future research and therapeutic use.

Bibliometrics is the field that focuses on analyzing and evaluating many aspects of scientific literature, such as its quantity, quality, citation patterns, and distribution across different disciplines ( 8 ). Bibliometrics allows for the quantitative analysis of trends and developments in scientific research. It enables the assessment of the influence and quality of academic outcomes, as well as the identification of collaborative links and disciplinary intersections within the academic community. Bibliometrics encompasses a wide range of academic literature, including research papers, monographs, patents, and conference papers. Bibliometric methods allow for the creation of literature databases, examination of literature citations, evaluation of academic performance for both institutions and academics and the provision of an unbiased foundation for scientific research policy development and academic assessment. Bibliometrics is crucial in scientific research administration, academic evaluation, and the formulation of scientific research policies ( 9 ).

Although there has been a significant amount of literature on the relationship between vitamin D and type 2 diabetes in the past twenty years, no bibliometric study has been carried out on this topic. In light of this, we undertook an extensive bibliometric review of the literature pertaining to the relationship between vitamin D and type 2 diabetes, encompassing the years 2004 to 2023. Through the examination of the published articles, we can determine the countries, institutions, authors, and journals that have the greatest quantity of publications. By analyzing the relevant keywords, we may gain a deeper understanding of the current areas of focus in research and predict future trends. This analysis can assist researchers in selecting their research paths and identifying emerging areas of study.

2. Materials and methods

2.1. data sources and retrieval strategies.

On February 20, 2024, we conducted a search on the Web of Science Core Collection (WoSCC) for items that were published between January 1, 2004, and December 31, 2023. To mitigate the impact of frequent database revisions, we successfully conducted the search and retrieval of the data within a single day. The search approach for obtaining papers in WoSCC is as outlined: The search terms include “TS = (Diabetes Mellitus Type 2)” OR “TS = (Type 2 Diabetes Mellitus)” OR “TS = (Type 2 Diabetes)” OR “TS = (Diabetes Mellitus Type)” OR “TS = (Type II Diabetes Mellitus)” OR “TS = (Type II Diabetes)” AND “TS = (Vitamin D)”. The search is limited to articles. To guarantee the precision of our bibliometric analysis, we conducted a comprehensive evaluation of each retrieved article by carefully evaluating its title, abstract, and year of publication. The study employed the following exclusion criteria: (1) articles that were not related to the topic of vitamin D and type 2 diabetes; (2) documents in formats other than articles, such as editorials, letters, reviews, and conference abstracts; (3) duplicate publications; and (4) publications that were not in the English language. Ultimately, the research resulted in the identification of 1,362 publications about the relationship between vitamin D and type 2 diabetes ( Figure 1 ).

Flow chart of the study.

2.2. Bibliometric analysis

We further conducted a bibliometric analysis of 1,362 publications related to vitamin D and type 2 diabetes from January 1, 2004, to December 31, 2023. Based on the bibliometric analysis methods from previous studies, this study utilizes analysis software such as R version 4.3.2, VOSviewer, and CiteSpace ( 10 – 15 ). R software serves as a potent statistical programming tool, equipped with extensive capabilities for data handling and visualization ( 16 ). It boasts a plethora of extendable packages, such as bibliometrix and biblioshiny, which offer comprehensive functionalities for bibliometric analysis ( 17 , 18 ). In this study, the bibliometrix package in R software was employed for initial publication statistics ( 17 ). VOSviewer specializes in bibliometric network visualization, particularly adept at generating scientific knowledge maps. This research leveraged VOSviewer to visualize co-authorship and time-based network analyses ( 11 , 19 ). Additionally, ArcMap 10.8.1, known for geospatial analysis and cartographic visualization, was used to create a global map of research distribution ( 20 ). CiteSpace, known for analyzing citation networks and keyword co-occurrences, was utilized to identify citation burst years and develop a dual-map overlay ( 21 ).

3.1. Overview

A total of 1362 articles were included in this study ( Figure 2 ). Between 2004 and 2016, the number of articles had a predominantly rising trajectory. Nevertheless, between 2016 and 2023, there was a substantial decrease in the quantity of publications. The cumulative number of articles exhibited a consistent annual growth from 2004 to 2023. In 2020, the total number of articles published on the topic of vitamin D and type 2 diabetes exceeded one thousand.

Number of publications per year and cumulative number of publications per year.

3.2. Analysis of country and region publications

Figure 3 indicates that there were 1362 research publications published on the topic of vitamin D and type 2 diabetes, spanning over 87 distinct nations. The majority of these articles originated from the United States and China, with notable contributions from the United Kingdom, Iran, and Italy ( Table 1 ). Significantly, the United States achieved the top position in the total citation index, showcasing its supremacy in vitamin D and type 2 diabetes research.

World map displaying the global distribution of research on Vitamin D and Type 2 Diabetes.

Table 1

Top 10 countries with most publications.

We performed bibliometric research to investigate the collaborative connections between countries and regions. The United States and China exhibited the most frequent instances of collaboration, surpassing the United States and the United Kingdom, which occurred 27 and 14 times, respectively. To better understand the extent of collaboration among these 87 countries, we undertook a co-authorship analysis.

The clustering network visually represents the number of publications based on the size of the circles ( Figure 4 ). The hue of the circles corresponds to the degree of collaboration within the study team. The red cluster contains 32 items, the green cluster contains 22 elements, and the blue cluster contains 17 elements. Italy, Canada, and Brazil belong to the red cluster, while the United States, Iran, and India are part of the green region. China and the United Kingdom are grouped in the blue region. In the case of networks that have temporal overlap, the color of the circle represents the mean year of publication for each country within a specific study area. The analysis of the time-overlapping network suggests that China entered the field later than countries like the United States and the United Kingdom, who were the pioneers in this area ( Supplementary Attachment 1 ).

Network clustering of country co-authorship analysis.

3.3. Analysis of institution publications

There have been 2,120 academic institutes that have carried out and published research on the relationship between vitamin D and type 2 diabetes. Out of them, 174 institutions have published a minimum of five articles. Table 2 provides the ranking of the top 10 colleges based on the number of articles they have published. Tehran University of Medical Sciences and Health Services has published the greatest quantity of publications, with a total of 33 papers. Harvard University and King Saud University have published 30 and 29 publications, respectively, following the top-ranked university.

Table 2

The top 10 institutions with the most publications.

We conducted a cluster analysis on the 174 institutions, as shown in Figure 5 . The red cluster, which primarily comprises 26 universities, predominantly from the United States, is the largest among all. Harvard University, along with other prominent U.S. research institutions, played a pivotal role in the initial advancement of vitamin D and its relationship to type 2 diabetes. After 2018, several Chinese research organizations increased their participation in studies on vitamin D and type 2 diabetes ( Supplementary Attachment 1 ).

Network clustering of institution co-authorship analysis.

3.4. Analysis of journals

The study’s articles were disseminated among 469 distinct journals. Table 3 displays the leading 10 publications together with their most recent impact factors for the year 2022. Five of the top 10 journals are in the highest quartile (Q1) of the JCR. H The three journals with the highest h-index are DIABETES CARE, JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM, and PLOS ONE.

Table 3

Top 10 most published journals.

Dual-map overlay is a visualization technique that, by analyzing the citation relationships between disciplines, reveals the interactions and influences among different disciplines, aiding in the understanding of knowledge flow and integration between fields. In Supplementary Attachment 1 , the journals on the left are the cited journals, whereas those on the right are the citing journals, with lines indicating the citation pathways. In this analysis, three key reference paths have been identified. The yellow path signifies that articles from journals in Molecular/Biology/Genetics are cited by articles in Molecular/Biology/Immunology. On the other hand, the green citation path indicates that articles from Molecular/Biology/Genetics and Medicine/Medical/Clinical journals are primarily cited by articles published in Health/Nursing/Medicine journals.

3.5. Most cited publications

The most cited publications may encompass seminal works, significant research findings, pivotal research breakthroughs, or innovative studies. Through the analysis of these extensively referenced articles, scholars can gain insight into the prevailing academic patterns, significant research pathways, and notable contributions made by exceptional researchers in the field ( 22 ). Table 4 displays the top 10 articles that have received more than 300 citations.

Table 4

Top 10 most frequently cited documents.

3.6. Analysis of the author

This study conducted a thorough examination of the existing literature on the relationship between vitamin D and type 2 diabetes. The analysis had a total of 7974 writers. Anastassios G. Pittas has authored 22 publications and has an h-index of 42, making him the most productive author, as indicated in Table 5 . Nasser Al-Daghri has authored 16 articles and has an h-index of 51. On the other hand, Jorde, Rolf has published 12 articles and has an h-index of 63.

Table 5

Top 10 most published authors.

Among the 7974 authors, only a mere 90 individuals managed to produce a minimum of 5 publications. We conducted a network analysis on the 90 writers, examining their co-authorship and temporal overlap. Circle size was used to represent the number of publications, while color was used to show clustering. The cluster analysis results indicate that collaborations predominantly occur inside countries, while direct cooperation between different countries is very infrequent. This indicates the necessity to bolster collaboration among worldwide research teams and augment the global interchange of pertinent research ( Figure 6 ). Temporal co-occurrence network analysis revealed that researchers in China conducted relevant research later ( Supplementary Attachment 1 ).

Network clustering of author co-authorship analysis.

3.7. Frequency and clustering analysis of keywords

Keyword co-occurrence analysis is a commonly used bibliometric method that reveals the relationships between research themes, disciplinary fields, or concepts by analyzing the co-occurrence of keywords in the research literature ( 23 ). In this study, keywords with the same meaning were merged, and ineffective keywords were eliminated, ultimately identifying 86 keywords that met the criterion of appearing at least ten times. By generating a density map, the distribution of popular themes across the field can be easily observed. As shown in Figure 7 , the most popular elements are “cardiovascular disease,” “metabolic syndrome,” “insulin resistance,” “vitamin D receptor,” and “supplementation.” These elements are prominently displayed on the density map.

Density map of keywords.

Subsequently, we conducted a clustering analysis using the selected keywords. Six clusters composed of 89 high-frequency keywords represent the six main research areas of the theme ( Figure 8 ). Cluster 1 is the largest, marked with a red circle, primarily focusing on cardiovascular disease and lipid profile, containing a total of 23 keywords. Cluster 2 includes 14 keywords, represented by a green circle, mainly involving inflammation. Cluster 3, denoted by a dark blue circle, emphasizes body composition and bone metabolism. The yellow cluster mainly studies diabetic complications. The blue cluster primarily relates to diet and lifestyle. Cluster 6, in light blue, mainly focuses on mechanisms.

Co-occurrence network of keywords.

Finally, we present a graphical representation of the keyword network over time, as shown in Figure 9 . Yellow indicates the most recent keywords, while purple represents the earlier ones. Early research focused on keywords such as “cardiovascular disease,” “glucagon secretion,” and “pancreatic secretion.” More recent studies concentrate on themes like “oxidative stress,” “peripheral neuropathy,” and “Alzheimer’s disease.” The keyword burst detection has shown that “bone turnover” and “peripheral neuropathy” are keywords that have continued to burst up to the year 2023 ( Figure 10 ).

Time-overlapping network of keywords.

Top 20 keywords with the strongest citation bursts.

4. Discussion

This study utilizes bibliometric methods to provide a comprehensive evaluation of academic achievements related to vitamin D and type 2 diabetes research over the past two decades. We have identified publication trends, regional distributions, and collaborations among countries and institutions in articles related to this topic, and further evaluated highly cited papers. Additionally, our groundbreaking findings reveal that research on bone turnover and peripheral neuropathy might be promising directions for future investigations. These findings provide additional insights for research policymakers.

Drawing upon previous research and focusing on the highly cited literature identified in this study, we conducted a comprehensive literature review of the relationship between vitamin D and type 2 diabetes. The number of citations an article receives is an important indicator of the impact of academic achievements, reflecting to some extent the academic value and influence of the article, a significance that cannot be overlooked ( 24 ). In terms of clinical research, as early as 2006, a large prospective study indicated that women with higher daily intakes of vitamin D had a significantly reduced risk of developing diabetes ( 25 ). In 2013, a meta-analysis of prospective studies presented similar conclusions, finding a significant inverse relationship between 25(OH)D levels and the incidence of type 2 diabetes. This observed inverse correlation was not affected by gender, sample size of the study, duration of follow-up, criteria for diabetes diagnosis, and methods of measuring 25(OH)D ( 26 ). Similarly, an exposure-wide umbrella review of meta-analyses in 2018 indicated an inverse relationship between blood levels of vitamin D and the risk of type 2 diabetes ( 27 ). However, a multicenter, randomized, placebo-controlled trial in 2019 showed that daily supplementation with 4000 IU of vitamin D3 did not lead to a significant reduction in diabetes risk ( 28 ). In terms of the underlying mechanisms, a significant amount of research has been conducted by scientists. A study ( 29 ) in 2004 demonstrated that the concentration of 25(OH)D is positively correlated with insulin sensitivity and negatively correlated with β-cell function in cases of vitamin D deficiency. Subjects with vitamin D deficiency were found to be at a higher risk of insulin resistance and metabolic syndrome. A 2008 study showed that a single large dose of oral vitamin D2 could improve endothelial function in patients with type 2 diabetes and vitamin D deficiency. Further studies have indicated a negative correlation between baseline serum 25(OH)D levels and future blood glucose and insulin resistance ( 30 ). A clinical trial in 2011 revealed that vitamin D supplementation could improve the disposition index and insulin secretion, associating vitamin D supplementation with improved pancreatic β-cell function in adults at high risk for type 2 diabetes, and it showed a trend toward reducing the rise in HbA1c ( 31 ). Vitamin D supplementation also has certain clinical application value in preventing diabetes complications. Adding paricalcitol to RAAS inhibitors can safely reduce residual albuminuria in patients with diabetic nephropathy and may represent a new method to reduce the residual renal risk in diabetic patients ( 32 ). Additionally, vitamin D is related to peripheral nerve conduction; patients with vitamin D deficiency often experience more neuropathic deficits associated with diabetic peripheral neuropathy. Vitamin D deficiency is also considered a risk factor for diabetic retinopathy ( 33 ). Clinical studies have demonstrated that vitamin D supplementation is effective in treating diabetic retinopathy ( 34 ). However, additional large-scale studies are needed to determine the optimal timing and duration of vitamin D intervention in type 2 diabetes and its complications.

Burst detection is an important feature in CiteSpace, primarily used to identify and analyze the sudden growth of keywords or topics within a certain period, thereby revealing emerging trends and hotspots in research fields ( 35 ). “Bone turnover” and “peripheral neuropathy” are keywords that have continued to burst up to the year 2023. Studies have shown that the concentration of 25(OH)D is negatively correlated with insulin resistance and bone turnover. Insulin resistance increases with the decrease in 25(OH)D concentration, which can enhance bone turnover and increase the risk of osteoporosis in non-osteoporotic type 2 diabetes patients ( 36 ). Furthermore, research has found that vitamin D may play a direct or indirect significant role in the positive correlation between bone metabolism and basal metabolism. This relationship is more evident in patients with increased serum 25(OH)D levels and those receiving Alfacalcidol supplementation. This suggests that improving vitamin D levels and Alfacalcidol supplementation may help improve bone metabolism and basal metabolism in postmenopausal women with type 2 diabetes ( 37 ). Vitamin D is related to the conduction capability of peripheral nerves and may have a neuro-selective and threshold-selective relationship with the incidence and severity of diabetic peripheral neuropathy in type 2 diabetes patients. In summary, research related to diabetes and bone metabolism, and vitamin D and diabetic neuropathy, are current research hotspots and future research trends ( 37 ).

To our knowledge, this is the first bibliometric analysis in this field. Existing publications focus mainly on isolated studies, such as individual mechanisms. Our study offers a comprehensive analysis of global literature on Vitamin D and type 2 diabetes, highlighting future research hotspots and trends to better assist researchers. However, this study also has some limitations. The quantitative indicators commonly used in bibliometrics, although capable of reflecting the impact of scientific achievements to some extent, may be influenced by various factors such as disciplinary fields, the age of the literature, and the popularity of research topics, and do not equate directly to research quality or impact. Furthermore, this study is primarily based on published scientific literature, which may overlook important information contained in unpublished research, academic conference reports, and other informal publications.

Acknowledgments

The authors would like to thank CiteSpace and VOSviewer for providing free access to researchers.

Funding Statement

The author(s) declare that no financial support was received for the research, authorship, and/or publication of this article.

Data availability statement

Author contributions.

RX: Writing – original draft, Writing – review & editing. XS: Writing – original draft, Writing – review & editing. HQ: Writing – original draft, Writing – review & editing. HY: Writing – original draft, Writing – review & editing. YX: Writing – original draft, Writing – review & editing, Funding acquisition.

Conflict of interest

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Publisher’s note

All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.

Supplementary material

The Supplementary Material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/fendo.2024.1421953/full#supplementary-material

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• NEWS EXPLAINER
• 28 August 2024

Mpox is spreading rapidly. Here are the questions researchers are racing to answer

• Sara Reardon

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Monkeypox virus particles (shown in this coloured electron micrograph) can spread through close contact with people and animals. Credit: NIAID/Science Photo Library

When the World Health Organization (WHO) declared a public-health emergency over mpox earlier this month , it was because a concerning form of the virus that causes the disease had spread to multiple African countries where it had never been seen before. Since then, two people travelling to Africa — one from Sweden and one from Thailand — have become infected with that type of virus, called clade Ib, and brought it back to their countries.

Monkeypox virus: dangerous strain gains ability to spread through sex, new data suggest

Although researchers have known about the current outbreak since late last year, the need for answers about it is now more pressing than ever. The Democratic Republic of the Congo (DRC) has spent decades grappling with monkeypox clade I virus — the lineage to which Ib belongs. But in the past, clade I infections usually arose when a person came into contact with wild animals, and outbreaks would fizzle out.

Clade Ib seems to be different, and is spreading largely through contact between humans, including through sex . Around 18,000 suspected cases of mpox, many of them among children, and at least 600 deaths potentially attributable to the disease have been reported this year in the DRC alone.

How does this emergency compare with one declared in 2022, when mpox cases spread around the globe? How is this virus behaving compared with the version that triggered that outbreak, a type called clade II? And will Africa be able to rein this one in? Nature talks to researchers about information they are rushing to gather.

Is clade Ib more deadly than the other virus types?

It’s hard to determine, says Jason Kindrachuk, a virologist at the University of Manitoba in Winnipeg, Canada. He says that the DRC is experiencing two outbreaks simultaneously. The clade I virus, which has been endemic in forested regions of the DRC for decades, circulates in rural regions, where people get it from animals. That clade was renamed Ia after the discovery of clade Ib. Studies in animals suggest that clade I is deadlier than clade II 1 — but Kindrachuk says that it’s hard to speculate on what that means for humans at this point.

Even when not fatal, mpox can trigger fevers, aches and painful fluid-filled skin lesions.

Growing mpox outbreak prompts WHO to declare global health emergency

Although many reports state that 10% of clade I infections in humans are fatal, infectious-disease researcher Laurens Liesenborghs at the Institute of Tropical Medicine in Antwerp, Belgium, doubts that this figure is accurate. Even the WHO’s latest estimate of a 3.5% fatality rate for people with mpox in the DRC might be high.

There are many reasons that fatality estimates might be unreliable, Liesenborghs says. For one, surveillance data capture only the most severe cases; many people who are less ill might not seek care at hospitals or through physicians, so their infections go unreported.

Another factor that can confound fatality rates is a secondary health condition. For example, people living with HIV — who can represent a large proportion of the population in many African countries — die from mpox at twice the rate of the general population 2 , especially if their HIV is untreated. And the relatively high death rate among children under age 5 could be partly because of malnutrition, which is common among kids in rural parts of the DRC, Liesenborghs says.

Is clade Ib more transmissible than other types?

The clade Ib virus has garnered particular attention because epidemiological data suggest that it transmits more readily between people than previous strains did, including through sexual activity, whereas clade Ia mostly comes from animals. An analysis posted ahead of peer review on the preprint server medRxiv 3 shows that clade Ib’s genome contains genetic mutations that seem to have been induced by the human immune system, suggesting that it has been in humans for some time. Clade Ia genomes have fewer of these mutations.

But Liesenborghs says that the mutations and clades might not be the most important factor in understanding how monkeypox virus spreads. Although distinguishing Ia from Ib is useful in tracking the disease, he says, the severity and transmissibility of the disease could be affected more by the region where the virus is circulating and the people there. Clade Ia, for instance, seems to be more common in sparsely populated rural regions where it is less likely to spread far. Clade Ib is cropping up in densely populated areas and spreading more readily.

Jean Nachega, an infectious-disease physician at the University of Pittsburgh in Pennsylvania, says that scientists don’t understand many aspects of mpox transmission — they haven’t even determined which animal serves as a reservoir for the virus in the wild, although rodents are able to carry it. “We have to be very humble,” Nachega says.

How effective are vaccines against the clade I virus?

Just as was the case during the COVID-19 pandemic, health experts are looking to vaccines to help curb this mpox outbreak. Although there are no vaccines designed specifically against the monkeypox virus, there are two vaccines proven to ward off a related poxvirus — the one that causes smallpox. Jynneos, made by biotechnology company Bavarian Nordic in Hellerup, Denmark, contains a type of poxvirus that can’t replicate but can trigger an immune response. LC16m8, made by pharmaceutical company KM Biologics in Kumamoto, Japan, contains a live — but weakened — version of a different poxvirus strain.

Hopes dashed for drug aimed at monkeypox virus spreading in Africa

Still, it’s unclear how effective these smallpox vaccines are against mpox generally. Dimie Ogoina, an infectious-disease specialist at Niger Delta University in Wilberforce Island, Nigeria, points out that vaccines have been tested only against clade II virus in European and US populations, because these shots were distributed by wealthy nations during the 2022 global outbreak . And those recipients were primarily young, healthy men who have sex with men, a population that was particularly susceptible during that outbreak. One study in the United States found that one dose of Jynneos was 80% effective at preventing the disease in at-risk people, whereas two doses were 82% effective 4 ; the WHO recommends getting both jabs.

People in Africa infected with either the clade Ia or Ib virus — especially children and those with compromised immune systems — might respond differently. However, one study in the DRC found that the Jynneos vaccine generally raised antibodies against mpox in about 1,000 health-care workers who received it 5 .

But researchers are trying to fill in some data gaps. A team in the DRC is about to launch a clinical trial of Jynneos in people who have come into close contact with the monkeypox virus — but have not shown symptoms — to see whether it can prevent future infection, or improve outcomes if an infection arises.

Will the vaccines help to rein in the latest outbreak?

Mpox vaccines have been largely unavailable in Africa, but several wealthy countries have pledged to donate doses to the DRC and other affected African nations. The United States has offered 50,000 Jynneos doses from its national stockpile, and the European Union has ordered 175,000, with individual member countries pledging extra doses. Bavarian Nordic has also added another 40,000. Japan has offered 3.5 million doses of LC16m8 — for which only one jab is recommended instead of two.

Monkeypox in Africa: the science the world ignored

None of them have arrived yet, though, says Espoir Bwenge Malembaka, an epidemiologist at the Catholic University of Bukavu in the DRC. Low- and middle-income nations cannot receive vaccines until the WHO has deemed the jabs safe and effective. And the WHO has not given its thumbs up yet. It is evaluating data from vaccine manufacturers, delaying donors’ ability to send the vaccines.

Even when the vaccines arrive, Bwenge Malembaka says, “it’s really a drop in the bucket”. The Africa Centres for Disease Control and Prevention in Addis Ababa, Ethiopia, estimates that 10 million doses are needed to rein in the outbreak.

Bwenge Malembaka says that the uncertainty over vaccine arrival has made it difficult for the government to form a distribution plan. “I don’t know how one can go about this kind of challenge,” he says. Bwenge Malembaka suspects that children are likely to receive doses first, because they are highly vulnerable to clade I, but officials haven’t decided which regions to target. It’s also unclear how the government would prioritize other vulnerable populations such as sex workers, who have been affected by clade Ib. Their profession is criminalized in the DRC, so they might not be able to come forward for treatment.

Researchers lament that public-health organizations didn’t provide vaccines and other resources as soon as the clade I outbreak was identified, especially given lessons learnt from the 2022 global mpox outbreak. “The opportunity was there a couple months ago to cut this transmission chain, but resources weren’t available,” Liesenborghs says. “Now, it will be more challenging to tackle this outbreak, and the population at risk is much broader.”

Nature 633 , 16-17 (2024)

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