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Page 1 of 91

Mesothelin- and nucleolin-specific T cells from combined short peptides effectively kill triple-negative breast cancer cells

Triple-negative breast cancer (TNBC), known for its aggressiveness and limited treatment options, presents a significant challenge. Adoptive cell transfer, involving the ex vivo generation of antigen-specific ...

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Diurnal timing of physical activity and risk of colorectal cancer in the UK Biobank

Physical activity reduces colorectal cancer risk, yet the diurnal timing of physical activity in colorectal cancer etiology remains unclear.

Accelerometer-derived moderate-to-vigorous physical activity and incident nonalcoholic fatty liver disease

The liver effects of concentrated vs. more evenly distributed moderate-to-vigorous physical activity (MVPA) patterns remain unclear. We aimed to examine the association of accelerometer-measured MVPA and diffe...

Impact of propofol versus desflurane anesthesia on postoperative hepatic and renal functions in infants with living-related liver transplantation: a randomized controlled trial

The effects of anesthetics on liver and kidney functions after infantile living-related liver transplantation (LRLT) are unclear. This study aimed to investigate the effects of propofol-based total intravenous...

Risk of suicide after hospitalizations due to acute physical health conditions—a cohort study of the Norwegian population

It is well known that individuals recently discharged from psychiatric inpatient care face a high risk of suicide. Severe physical health conditions have also been linked to suicide risk. The risk of suicide f...

A novel intrauterine estrogen-releasing system for preventing the postoperative recurrence of intrauterine adhesion: a multicenter randomized controlled study

Transcervical resection of adhesions (TCRA) is the standard treatment for intrauterine adhesion (IUA). Previous studies have shown that postoperative oral estrogen or an intrauterine physical barrier could red...

Real-world impact of acupuncture on analgesics and healthcare resource utilization in breast cancer survivors with pain

This study evaluated the real-world impact of acupuncture on analgesics and healthcare resource utilization among breast cancer survivors.

Prenatal environmental risk factors for autism spectrum disorder and their potential mechanisms

Autism spectrum disorder (ASD) is a neurodevelopmental disorder that is globally increasing in prevalence. The rise of ASD can be partially attributed to diagnostic expansion and advocacy efforts; however, the...

Interactive effect of air pollution and genetic risk of depression on processing speed by resting-state functional connectivity of occipitoparietal network

Air pollution, a reversible environmental factor, was significantly associated with the cognitive domains that are impaired in major depressive disorder (MDD), notably processing speed. Limited evidence explor...

Adiposity and mortality among intensive care patients with COVID-19 and non-COVID-19 respiratory conditions: a cross-context comparison study in the UK

Adiposity shows opposing associations with mortality within COVID-19 versus non-COVID-19 respiratory conditions. We assessed the likely causality of adiposity for mortality among intensive care patients with C...

Sleep patterns, physical activity, genetic susceptibility, and incident rheumatoid arthritis: a prospective cohort study

Sleep and physical activity (PA) are thought to be interconnected with the development of rheumatoid arthritis (RA). However, the precise nature and extent of these relationships have yet to be fully quantifie...

Efficacy of respiratory support therapies during pulmonary rehabilitation exercise training in chronic obstructive pulmonary disease patients: a systematic review and network meta-analysis

Exercise training is fundamental in pulmonary rehabilitation (PR), but patients with chronic obstructive pulmonary disease (COPD) often struggle with exercise intolerance. Respiratory support during exercise i...

A systems serology approach to identifying key antibody correlates of protection from cerebral malaria in Malawian children

Plasmodium falciparum erythrocyte membrane protein 1 (PfEMP1) proteins are expressed on the surface of infected erythrocytes, mediating parasite sequestration in the vasculature. PfEMP1 is a major target of prote...

The impact of an exercise and sport intervention on cognitive function and pain among forcibly displaced individuals at risk for PTSD: a secondary analysis of the SALEEM randomized controlled trial

In response to the global scope of forced displacement, international organizations highlight the need of scalable solutions to support individuals’ health and integration into host societies. Exposure to high...

Association of depressive symptoms with incidence and mortality rates of COVID-19 over 2 years among healthcare workers in 20 countries: multi-country serial cross-sectional study

Long-term deterioration in the mental health of healthcare workers (HCWs) has been reported during and after the COVID-19 pandemic. Determining the impact of COVID-19 incidence and mortality rates on the menta...

Replacement of sedentary behavior with various physical activities and the risk of all-cause and cause-specific mortality

Sedentary behavior (SB) has emerged as a significant health concern that deserves attention. This study aimed to examine the associations between prolonged sedentary behavior and the risk of all-cause and caus...

Evaluating the impact of extended dosing intervals on mRNA COVID-19 vaccine effectiveness in adolescents

Extending the dosing interval of a primary series of mRNA COVID-19 vaccination has been employed to reduce myocarditis risk in adolescents, but previous evaluation of impact on vaccine effectiveness (VE) is li...

Single-cell sequencing of the vermiform appendix during development identifies transcriptional relationships with appendicitis in preschool children

The development of the human vermiform appendix at the cellular level, as well as its function, is not well understood. Appendicitis in preschool children, although uncommon, is associated with a high perforat...

Between faces: childhood adversity is associated with reduced threat-safety discrimination during facial expression processing in adolescence

Childhood adversity has been associated with alterations in threat-related information processing, including heightened perceptual sensitivity and attention bias towards threatening facial expressions, as well...

Integration of clinical and blood parameters in risk prognostication for patients receiving immunochemotherapy for extensive stage small cell lung cancer: real-world data from two centers

Immune checkpoint inhibitors (ICIs) had modest advances in the treatment of extensive-stage small cell lung cancer (ES-SCLC) in clinical trials, but there is a lack of biomarkers for prognosis in clinical prac...

Global acute malnutrition is associated with geography, season and malaria incidence in the conflict-affected regions of Ouham and Ouham Pendé prefectures, Central African Republic

Ongoing conflict between multiple armed groups, including pastoralist herders in the Central African Republic (CAR) causes frequent population displacements, food insecurity and scarcity of healthcare services...

Helicobacter pylori seropositivity associates with hyperglycemia, but not obesity, in Danish children and adolescents

Helicobacter pylori colonizes the human stomach and may affect the inflammatory response, hormone production related to energy regulation, and gastrointestinal microbiota composition. Previous studies have explor...

Potential deprescribing indications for antidepressants between 2012 and 2019: repeated cross-sectional analysis in two Scottish health boards

Antidepressants have a pivotal role in the treatment of many psychiatric disorders, but there are concerns about long-term use and adverse effects. The objectives of this study were (1) to examine time trends ...

Development and validation of machine-learning models of diet management for hyperphenylalaninemia: a multicenter retrospective study

Assessing dietary phenylalanine (Phe) tolerance is crucial for managing hyperphenylalaninemia (HPA) in children. However, traditionally, adjusting the diet requires significant time from clinicians and parents...

IL-17A exacerbates corpus cavernosum fibrosis and neurogenic erectile dysfunction by inducing CSMC senescence via the mTORC2-ACACA pathway

Neurogenic erectile dysfunction, characterized by neurological repair disorders and progressive corpus cavernosum fibrosis (CCF), is an unbearable disease with limited treatment success. IL-17A exhibits a comp...

A deep learning model for differentiating paediatric intracranial germ cell tumour subtypes and predicting survival with MRI: a multicentre prospective study

The pretherapeutic differentiation of subtypes of primary intracranial germ cell tumours (iGCTs), including germinomas (GEs) and nongerminomatous germ cell tumours (NGGCTs), is essential for clinical practice ...

Addressing the credibility crisis in Mendelian randomization

Genome-wide association studies have enabled Mendelian randomization analyses to be performed at an industrial scale. Two-sample summary data Mendelian randomization analyses can be performed using publicly av...

Newborn DNA methylation age differentiates long-term weight trajectories: the Boston Birth Cohort

Gestational age (GEAA) estimated by newborn DNA methylation (GAmAge) is associated with maternal prenatal exposures and immediate birth outcomes. However, the association of GAmAge with long-term overweight or...

Trends in the healthiness and nutrient composition of packaged products sold by major food and beverage companies in New Zealand 2015 to 2019

Dietary risk factors are the leading cause of death globally and in New Zealand (NZ). Processed packaged foods are prevalent in the food supply and contribute excess amounts of sodium, saturated fat, and sugar...

Air pollution and risk of 32 health conditions: outcome-wide analyses in a population-based prospective cohort in Southwest China

Uncertainty remains about the long-term effects of air pollutants (AP) on multiple diseases, especially subtypes of cardiovascular disease (CVD). We aimed to assess the individual and joint associations of fin...

Has multimorbidity and frailty in adult hospital admissions changed over the last 15 years? A retrospective study of 107 million admissions in England

Few studies have quantified multimorbidity and frailty trends within hospital settings, with even fewer reporting how much is attributable to the ageing population and individual patient factors. Studies to da...

Cardiovascular health and cancer mortality: evidence from US NHANES and UK Biobank cohort studies

The American Heart Association recently introduced a novel cardiovascular health (CVH) metric, Life's Essential 8 (LE8), for health promotion. However, the relationship between LE8 and cancer mortality risk re...

Association of lifestyle with valvular heart disease progression and life expectancy among elderly people from different socioeconomic backgrounds

Current cardiovascular prevention strategies are based on studies that seldom include valvular heart disease (VHD). The role of modifiable lifestyle factors on VHD progression and life expectancy among the eld...

Effect of salt substitution on fracture—a secondary analysis of the Salt Substitute and Stroke Study (SSaSS)

Associations of dietary sodium and potassium intake with fracture risk are inconsistent and the effects of salt substitute on fracture incidence are unknown. We assessed the effect of salt substitute compared ...

Phase 1b study of first-line fuzuloparib combined with modified FOLFIRINOX followed by fuzuloparib maintenance monotherapy in pancreatic adenocarcinoma

Chemotherapy remains the standard first-line treatment for pancreatic adenocarcinoma, but with limited efficacy. We aimed to explore the feasibility of adding the PARP inhibitor fuzuloparib to mFOLFIRINOX in t...

The spatiotemporal associations between esophageal and gastric cancers provide evidence for its joint endoscopic screening in China: a population-based study

The spatiotemporal epidemiological evidence supporting joint endoscopic screening for esophageal cancer (EC) and gastric cancer (GC) remains limited. This study aims to identify combined high-risk regions for ...

Cancer incidence (2000–2020) among individuals under 35: an emerging sex disparity in oncology

Aggressive malignancies, such as pancreatic cancer, are increasingly impacting young, female populations. Our investigation centered on whether the observed trends in cancer incidence were unique to pancreatic...

Time-restricted eating with or without a low-carbohydrate diet improved myocardial status and thyroid function in individuals with metabolic syndrome: secondary analysis of a randomized clinical trial

Obesity and metabolic syndrome (MetS) have become urgent worldwide health problems, predisposing patients to unfavorable myocardial status and thyroid dysfunction. Low-carbohydrate diet (LCD) and time-restrict...

Hyperactivation of ATF4/TGF-β1 signaling contributes to the progressive cardiac fibrosis in Arrhythmogenic cardiomyopathy caused by DSG2 Variant

Arrhythmogenic cardiomyopathy (ACM) is an inherited cardiomyopathy characterized with progressive cardiac fibrosis and heart failure. However, the exact mechanism driving the progression of cardiac fibrosis an...

New-onset obstructive airway disease following COVID-19: a multicenter retrospective cohort study

The study assessed the association between COVID-19 and new-onset obstructive airway diseases, including asthma, chronic obstructive pulmonary disease, and bronchiectasis among vaccinated individuals recoverin...

The association of psychological and trauma-related factors with biological and facial aging acceleration: evidence from the UK Biobank

Psychological and trauma-related factors are associated with many diseases and mortality. However, a comprehensive assessment of the association between psycho-trauma exposures and aging acceleration is curren...

Effects of fructan and gluten on gut microbiota in individuals with self-reported non-celiac gluten/wheat sensitivity—a randomised controlled crossover trial

Individuals with non-celiac gluten/wheat sensitivity (NCGWS) experience improvement in gastrointestinal symptoms following a gluten-free diet. Although previous results have indicated that fructo-oligosacchari...

A functional variant rs912304 for late-onset T1D risk contributes to islet dysfunction by regulating proinflammatory cytokine-responsive gene STXBP6 expression

Our previous genome‑wide association studies (GWAS) have suggested rs912304 in 14q12 as a suggestive risk variant for type 1 diabetes (T1D). However, the association between this risk region and T1D subgroups ...

Advances and counterpoints in type 2 diabetes. What is ready for translation into real-world practice, ahead of the guidelines

This review seeks to address major gaps and delays between our rapidly evolving body of knowledge on type 2 diabetes and its translation into real-world practice. Through updated and improved best practices in...

Cruciferous vegetables lower blood pressure in adults with mildly elevated blood pressure in a randomized, controlled, crossover trial: the VEgetableS for vaScular hEaLth (VESSEL) study

Higher cruciferous vegetable intake is associated with lower cardiovascular disease risk in observational studies. The pathways involved remain uncertain. We aimed to determine whether cruciferous vegetable in...

Past trends and future projections of palliative care needs in Chile: analysis of routinely available death registry and population data

The number of people with palliative care needs is projected to increase globally. Chile has recently introduced legislation for universal access to palliative care services for patients with severe and termin...

Implementation of health-promoting retail initiatives in the Healthier Choices in Supermarkets Study—qualitative perspectives from a feasibility study

Improving food environments like supermarkets has the potential to affect customers’ health positively. Scholars suggest researchers and retailers collaborate closely on implementing and testing such health-pr...

Impact of a school-based water and hygiene intervention on child health and school attendance in Addis Ababa, Ethiopia: a cluster-randomised controlled trial

School-based water, sanitation and hygiene (WASH) may improve the health and attendance of schoolchildren, particularly post-menarcheal girls, but existing evidence is mixed. We examined the impact of an urban...

Patient-reported outcome measures for medication treatment satisfaction: a systematic review of measure development and measurement properties

Medication Treatment Satisfaction (M-TS) from the patients’ perspective is important for comprehensively evaluating the effect of medicines. The extent to which current patient-reported outcome measures (PROMs...

Gender-affirming hormonal therapy induces a gender-concordant fecal metagenome transition in transgender individuals

Limited data exists regarding gender-specific microbial alterations during gender-affirming hormonal therapy (GAHT) in transgender individuals. This study aimed to investigate the nuanced impact of sex steroid...

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Citation Impact 2023 Journal Impact Factor: 7.0 5-year Journal Impact Factor: 8.7 Source Normalized Impact per Paper (SNIP): 2.000 SCImago Journal Rank (SJR): 2.711 Speed 2023 Submission to first editorial decision (median days): 6 Submission to acceptance (median days): 145 Usage 2023 Downloads: 6,375,113 Altmetric mentions: 24,228

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Page 1 of 525

Predictors of tobacco use among pregnant women: a large-scale, retrospective study

To investigate the predictors of smoking among pregnant women in Iran, focusing on health literacy and associated socioeconomic factors.

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Risk factors of cardiovascular disease (CVD) in young adults: a community-based study of Iranian context

Cardiovascular disease (CVD) is the leading cause of death and disability worldwide, particularly in low- and middle-income countries. Young adults are susceptible to CVD risk factors, especially in developing...

Publisher Correction: Effects of the COVID-19 pandemic on the rates of adverse birth outcomes and fetal mortality in Japan: an analysis of national data from 2010 to 2022

The original article was published in BMC Public Health 2024 24 :1430

Chinese version of the Physical Resilience Scale (PRS): reliability and validity test based on Rasch analysis

Physical resilience is known to minimize the adverse outcomes of health stressors for older people. However, validated instruments that assess physical resilience in older adults are rare. Therefore, the purpo...

Access to land and nature as health determinants: a qualitative analysis exploring meaningful human-nature relationships among Indigenous youth in central Canada

Human relationships with and connections to nature and the “land” are a commonly accepted Social Determinant of Health. Greater knowledge about these relationships can inform public health policies and interve...

Body roundness index and the risk of hypertension: a prospective cohort study in Southwest China

Body roundness index (BRI) is an anthropometric measure related to obesity, combining waist circumference (WC) and height to more accurately reflect body fat. This study aims to investigate the relationship be...

Latent classes of adolescent health behaviour, social covariates and mental wellbeing: a longitudinal birth cohort study

Adolescent mental wellbeing has been declining in the United Kingdom for over a decade. Expansion of services to support the mental wellbeing of young people is a public health priority and a core component of...

Baltimore community resident and collaborator perspectives on the influence of guaranteed income on health: a formative qualitative study

Given increased interest and investment in guaranteed income initiatives across North America, it is critical to understand the impact of guaranteed income on health, an understudied outcome. As part of Baltim...

Investigating the mechanisms of internet gaming disorder and developing intelligent monitoring models using artificial intelligence technologies: protocol of a prospective cohort

Internet gaming disorder (IGD), recognized by the World Health Organization (WHO), significantly impacts adolescent mental and physical health. With a global prevalence of 3.05%, rates are higher in Asia, espe...

The association between weight loss behaviors and body weight perception in Chinese adolescents: 2007–2022

Weight misperceptions are common in children and adolescents, which is related to the engagement of weight loss behaviors. The aim of this study was to investigate the association between body weight perceptio...

The impact of diabetes mellitus on tuberculosis recurrence in Eastern China: a retrospective cohort study

The comorbidity of tuberculosis (TB) and diabetes mellitus (DM) is a significant global public health issue. This study aims to explore the recurrence risk and related factors of active pulmonary TB, specifica...

Adaptation of the socioecological model to address disparities in engagement of Black men in prostate cancer genetic testing

Black men consistently have higher rates of prostate cancer (PCA)- related mortality. Advances in PCA treatment, screening, and hereditary cancer assessment center around germline testing (GT). Of concern is t...

“ Build back the confidence”: qualitative exploration of community experiences with polio vaccination in the Covid-19 context in Cameroon and Ethiopia

In 2020, as the Global Polio Eradication Initiative worked to address outbreaks of vaccine-derived poliovirus Type 2, particularly in sub-Saharan Africa, the Covid-19 pandemic suspended routine immunization ca...

COVID-19 vaccine uptake in individuals with functional difficulty, disability, and comorbid conditions: insights from a national survey in Bangladesh

COVID-19 vaccine uptake among individuals with disabilities is crucial for safeguarding their health and well-being. However, the extent of vaccine uptake among this group remains largely unknown in low- and m...

Association between sleep regularity and arterial stiffness among middle-age adults in Southwestern China

Sleep regularity has been linked to a risk of arterial stiffness (AS). However, the association between sleep regularity indicators, which reflect 24-hour sleep variability, and AS has not yet been examined.

Interpregnancy interval, air pollution, and the risk of low birth weight: a retrospective study in China

Both interpregnancy intervals (IPI) and environmental factors might contribute to low birth weight (LBW). However, the extent to which air pollution influences the effect of IPIs on LBW remains unclear. We aim...

Linear and non-linear associations of depressive symptoms with oral health knowledge, attitudes, and practices among rural older adults in China: a cross-sectional study

Depression affects the oral health of older adults; however, little is known about its impact on oral health among rural older adults in developing countries, which warrants further research. Taking China as a...

Extent and causes of unused medications among patients in rural Ethiopia: a prospective multicenter cohort study

Medication waste poses health, economic, and environmental challenges. However, the extent among patients living in rural areas is underexplored. This study assessed the proportion of prescribed medications re...

Association between sexual violence and depression is mediated by perceived social support among female university students in the kingdom of Eswatini

Gender-based violence is a tool that primarily functions to maintain gendered power hierarchies. Manifestations of gender-based violence, sexual assault and street harassment have been shown to have significan...

Characteristics of higher education students who reported sexual violence: a Nigerian national study

Sexual violence among higher education students is a global public health problem. Identifying the characteristics of students who report victimization can serve as basis for programmes that target vulnerable ...

Spatial disparities and dynamic evolution of professional public health resource supply level in Beijing, China

This study aims to explore the development status of the supply level of professional public health resources in Beijing Municipality, analyze the areal differences and spatial distribution characteristics of ...

Prevalence estimates for COVID-19-related health behaviors based on the cheating detection triangular model

Survey studies in medical and health sciences predominantly apply a conventional direct questioning (DQ) format to gather private and highly personal information. If the topic under investigation is sensitive ...

Knowledge, attitudes and practices related to AIDS amongst transgender women in Chongqing, China: a cross-sectional study

Transgender women (TGWs) constitute one of the key populations for HIV prevention and control and constitute a high-risk group due to a lack of health services. The aim of this study was to investigate knowled...

Global, regional, and national burden of hearing loss in children and adolescents, 1990–2021: a systematic analysis from the Global Burden of Disease Study 2021

Hearing loss in children and adolescents is attracting increasing attention as a growing public health problem. This study aimed to analyze the burden of hearing loss in children and adolescents from 1990 to 2...

Stores Licensing Scheme in remote Indigenous communities of the Northern Territory, Australia: a meta-evaluation

A form of food retail regulation called the Stores Licensing Scheme was introduced by the Australian Government in 2007–2022 to ensure food security in remote Indigenous communities of the Northern Territory. ...

Exploring the trend of age-standardized mortality rates from cardiovascular disease in Malaysia: a joinpoint analysis (2010–2021)

Cardiovascular disease (CVD) is a major health concern worldwide, particularly in low- and middle-income countries. The COVID-19 pandemic that emerged in late 2019 may have had an impact on the trend of CVD mo...

A qualitative exploration of disseminating research findings among public health researchers in China

Research dissemination is essential to accelerate the translating of evidence into practice. Little is known about dissemination among Chinese public health researchers. This study aimed to explore the underst...

We will be different forever: A qualitative study of changes of body image in women with breast cancer

This study explores the experience of body-image changes throughout the trajectory of breast cancer.

Uncovering the relationship between trace element exposure, cognitive function, and dietary inflammation index in elderly americans from the National Health and Nutrition Examination Survey 2011–2014

The consequences of trace element exposure on cognitive function in elderly adults have been recognized as primarily attributed to the inflammatory response. It is noteworthy that diet can either exacerbate or...

Social isolation and loneliness among people living with experience of homelessness: a scoping review

Social isolation and loneliness (SIL) are public health challenges that disproportionally affect individuals who experience structural and socio-economic exclusion. The social and health outcomes of SIL for pe...

Exploring Cesarean Section Delivery Patterns in South India: A Bayesian Multilevel and Geospatial analysis of Population-Based Cross-Sectional Data

This paper focuses on the period from 2019 to 2021 and investigates the factors associated with the high prevalence of C-section deliveries in South India. We also examine the nuanced patterns, socio-demograph...

10-year risk for cardiovascular diseases according to the WHO prediction chart: findings from the National Health and Morbidity Survey (NHMS) 2019

There has been a significant increase in the incidence of cardiovascular disease (CVD) in Malaysia. It is important to identify the group at high risk of CVD. This study aimed to assess the population distribu...

HIV testing among female sex workers and associated factors in Burkina Faso: findings from a respondent-driven sampling survey

In Burkina Faso, only 70% of people living with HIV knew their status in 2018, while the first 95 target of the UNAIDS suggests that by 2025 at least 95% of people living with HIV (PLHIV) know their HIV status...

Prevalence and epidemiological distribution of indicators of pathogenic bacteria in households drinking water in Ethiopia: a systematic review and meta-analysis

Ensuring the availability of safe drinking water remains a critical challenge in developing countries, including Ethiopia. Therefore, this paper aimed to investigate the prevalence of fecal coliform and E. coli b...

Development and preliminary validation of the South Wales Social Well-being Scale (SWSWBS)

Physical, mental and social components of well-being are known to be important to health. However, research on well-being often focuses on physical and mental well-being with little attention paid to social we...

A cluster randomized controlled trial to assess the impact of the ‘Caring for Providers to Improve Patient Experience’ (CPIPE) intervention in Kenya and Ghana: study protocol

Poor person-centered maternal care (PCMC) contributes to high maternal mortality and morbidity, directly and indirectly, through lack of, delayed, inadequate, unnecessary, or harmful care. While evidence on po...

Health literacy and its association with antibiotic use and knowledge of antibiotic among Egyptian population: cross sectional study

High prevalence of inappropriate antibiotic use in different sectors of the community indicates a possible strong influence of social and cultural context, which may be influenced by social determinants of hea...

Psychometric properties of the social determinants of health questionnaire (SDH-Q): development and validation

The influence of social determinants of health (SDH) on sustainable development goals (SDG) has gained attention in recent years. However, there is a scarcity in the availability of valid and reliable instrume...

Children’s and adolescents’ views of health and mental health concepts - A qualitative group interview study

Definitions and perceptions of health and mental health have not remained static over time. This is also true for statistics over Swedish children’s and adolescents’ health and mental health status. The majori...

Psychometric properties of Arabic-translated-related quality of life scales for people with parkinson disease: a scoping review

Parkinson’s disease (PD) substantially contributes to poor functional outcomes, loss in productivity, and poor health-related quality of life (HRQoL). Despite the existence of various scales, there is a notabl...

Spatial and temporal analysis and forecasting of TB reported incidence in western China

Tuberculosis (TB) remains an important public health concern in western China. This study aimed to explore and analyze the spatial and temporal distribution characteristics of TB reported incidence in 12 provi...

Relationship between physical exercise, bullying, and being bullied among junior high school students: the multiple mediating effects of emotional management and interpersonal relationship distress

This paper investigates the relationships between physical activity (PA), school bullying, emotion regulation self-efficacy (ERS), and interpersonal relationship distress (IRD) among junior high school student...

Canadian beach cohort study: protocol of a prospective study to assess the burden of recreational water illness

Recreational water activities at beaches are popular among Canadians. However, these activities can increase the risk of recreational water illnesses (RWI) among beachgoers. Few studies have been conducted in ...

mhealth-based interventions to improving liver cancer screening among high-risk populations: a study protocol for a randomized controlled trial

Liver cancer (LC) screening, such as AFP test and abdominal ultrasound, is an effective way to prevent LC, one of the most common cancers worldwide. Despite the proven screening benefits, screening participati...

Association between total body muscle-fat ratio and risk of thyroid disorders: a cross-sectional study

Thyroid disorders(TD) poses a significant health threat to Americans due to its high incidence rate. Obesity, a common factor linked to thyroid disorders, has garnered increasing attention. While Body mass ind...

Age-related differences in the number of chronic diseases in association with trajectories of depressive symptoms: a population-based cohort study

The number of chronic diseases has been associated with changes in depressive symptoms over time among middle-aged and older adults. This study aimed to explore the association between the number of chronic di...

Prevalence of undiagnosed hypertension and associated factors in Ndera sector, Gasabo district of Rwanda: a cross-sectional study

Hypertension remains a major global health challenge, including in low- and middle-income countries. In Rwanda, a lack of adequate information and healthcare services impacts healthcare-seeking behaviors, cont...

Level of hesitation of parents about childhood vaccines and affecting factors: a cross-sectional study in Turkey

Hesitancy rates for childhood vaccines are increasing on a global scale. It was reported in previous studies that many factors affect vaccine hesitancy. The present study was designed to determine the prevalen...

Construction and validation of a risk prediction model for soldiers with frostbite in northeast China: a cross-sectional study

One of the challenges of physical training in extreme condition is frostbite, especially in Northeast China. In this study, we aimed to construct a risk prediction model for frostbite among soldiers in Northea...

Housing instability patterns among low-income, urban Black young adults in California and associations with mental health outcomes: baseline data from a randomized waitlist-controlled trial

Deep-rooted racial residential segregation and housing discrimination have given rise to housing disparities among low-income Black young adults in the US. Most studies have focused on single dimensions of hou...

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Citation Impact 2023 Journal Impact Factor: 3.5 5-year Journal Impact Factor: 3.9 Source Normalized Impact per Paper (SNIP): 1.386 SCImago Journal Rank (SJR): 1.253 Speed 2023 Submission to first editorial decision (median days): 7 Submission to acceptance (median days): 173 Usage 2023 Downloads: 24,332,405 Altmetric mentions: 24,308

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Clinical Trials and Clinical Research: A Comprehensive Review

Venkataramana kandi.

1 Clinical Microbiology, Prathima Institute of Medical Sciences, Karimnagar, IND

Sabitha Vadakedath

2 Biochemistry, Prathima Institute of Medical Sciences, Karimnagar, IND

Clinical research is an alternative terminology used to describe medical research. Clinical research involves people, and it is generally carried out to evaluate the efficacy of a therapeutic drug, a medical/surgical procedure, or a device as a part of treatment and patient management. Moreover, any research that evaluates the aspects of a disease like the symptoms, risk factors, and pathophysiology, among others may be termed clinical research. However, clinical trials are those studies that assess the potential of a therapeutic drug/device in the management, control, and prevention of disease. In view of the increasing incidences of both communicable and non-communicable diseases, and especially after the effects that Coronavirus Disease-19 (COVID-19) had on public health worldwide, the emphasis on clinical research assumes extremely essential. The knowledge of clinical research will facilitate the discovery of drugs, devices, and vaccines, thereby improving preparedness during public health emergencies. Therefore, in this review, we comprehensively describe the critical elements of clinical research that include clinical trial phases, types, and designs of clinical trials, operations of trial, audit, and management, and ethical concerns.

Introduction and background

A clinical trial is a systematic process that is intended to find out the safety and efficacy of a drug/device in treating/preventing/diagnosing a disease or a medical condition [ 1 , 2 ]. Clinical trial includes various phases that include phase 0 (micro-dosing studies), phase 1, phase 2, phase 3, and phase 4 [ 3 ]. Phase 0 and phase 2 are called exploratory trial phases, phase 1 is termed the non-therapeutic phase, phase 3 is known as the therapeutic confirmatory phase, and phase 4 is called the post-approval or the post-marketing surveillance phase. Phase 0, also called the micro-dosing phase, was previously done in animals but now it is carried out in human volunteers to understand the dose tolerability (pharmacokinetics) before being administered as a part of the phase 1 trial among healthy individuals. The details of the clinical trial phases are shown in Table ​ Table1 1 .

This table has been created by the authors.

MTD: maximum tolerated dose; SAD: single ascending dose; MAD: multiple ascending doses; NDA: new drug application; FDA: food and drug administration

Clinical research design has two major types that include non-interventional/observational and interventional/experimental studies. The non-interventional studies may have a comparator group (analytical studies like case-control and cohort studies), or without it (descriptive study). The experimental studies may be either randomized or non-randomized. Clinical trial designs are of several types that include parallel design, crossover design, factorial design, randomized withdrawal approach, adaptive design, superiority design, and non-inferiority design. The advantages and disadvantages of clinical trial designs are depicted in Table ​ Table2 2 .

There are different types of clinical trials that include those which are conducted for treatment, prevention, early detection/screening, and diagnosis. These studies address the activities of an investigational drug on a disease and its outcomes [ 4 ]. They assess whether the drug is able to prevent the disease/condition, the ability of a device to detect/screen the disease, and the efficacy of a medical test to diagnose the disease/condition. The pictorial representation of a disease diagnosis, treatment, and prevention is depicted in Figure ​ Figure1 1 .

This figure has been created by the authors.

The clinical trial designs could be improvised to make sure that the study's validity is maintained/retained. The adaptive designs facilitate researchers to improvise during the clinical trial without interfering with the integrity and validity of the results. Moreover, it allows flexibility during the conduction of trials and the collection of data. Despite these advantages, adaptive designs have not been universally accepted among clinical researchers. This could be attributed to the low familiarity of such designs in the research community. The adaptive designs have been applied during various phases of clinical trials and for different clinical conditions [ 5 , 6 ]. The adaptive designs applied during different phases are depicted in Figure ​ Figure2 2 .

The Bayesian adaptive trial design has gained popularity, especially during the Coronavirus Disease-19 (COVID-19) pandemic. Such designs could operate under a single master protocol. It operates as a platform trial wherein multiple treatments can be tested on different patient groups suffering from disease [ 7 ].

In this review, we comprehensively discuss the essential elements of clinical research that include the principles of clinical research, planning clinical trials, practical aspects of clinical trial operations, essentials of clinical trial applications, monitoring, and audit, clinical trial data analysis, regulatory audits, and project management, clinical trial operations at the investigation site, the essentials of clinical trial experiments involving epidemiological, and genetic studies, and ethical considerations in clinical research/trials.

A clinical trial involves the study of the effect of an investigational drug/any other intervention in a defined population/participant. The clinical research includes a treatment group and a placebo wherein each group is evaluated for the efficacy of the intervention (improved/not improved) [ 8 ].

Clinical trials are broadly classified into controlled and uncontrolled trials. The uncontrolled trials are potentially biased, and the results of such research are not considered as equally as the controlled studies. Randomized controlled trials (RCTs) are considered the most effective clinical trials wherein the bias is minimized, and the results are considered reliable. There are different types of randomizations and each one has clearly defined functions as elaborated in Table ​ Table3 3 .

Principles of clinical trial/research

Clinical trials or clinical research are conducted to improve the understanding of the unknown, test a hypothesis, and perform public health-related research [ 2 , 3 ]. This is majorly carried out by collecting the data and analyzing it to derive conclusions. There are various types of clinical trials that are majorly grouped as analytical, observational, and experimental research. Clinical research can also be classified into non-directed data capture, directed data capture, and drug trials. Clinical research could be prospective or retrospective. It may also be a case-control study or a cohort study. Clinical trials may be initiated to find treatment, prevent, observe, and diagnose a disease or a medical condition.

Among the various types of clinical research, observational research using a cross-sectional study design is the most frequently performed clinical research. This type of research is undertaken to analyze the presence or absence of a disease/condition, potential risk factors, and prevalence and incidence rates in a defined population. Clinical trials may be therapeutic or non-therapeutic type depending on the type of intervention. The therapeutic type of clinical trial uses a drug that may be beneficial to the patient. Whereas in a non-therapeutic clinical trial, the participant does not benefit from the drug. The non-therapeutic trials provide additional knowledge of the drug for future improvements. Different terminologies of clinical trials are delineated in Table ​ Table4 4 .

In view of the increased cost of the drug discovery process, developing, and low-income countries depend on the production of generic drugs. The generic drugs are similar in composition to the patented/branded drug. Once the patent period is expired generic drugs can be manufactured which have a similar quality, strength, and safety as the patented drug [ 9 ]. The regulatory requirements and the drug production process are almost the same for the branded and the generic drug according to the Food and Drug Administration (FDA), United States of America (USA).

The bioequivalence (BE) studies review the absorption, distribution, metabolism, and excretion (ADME) of the generic drug. These studies compare the concentration of the drug at the desired location in the human body, called the peak concentration of the drug (Cmax). The extent of absorption of the drug is measured using the area under the receiver operating characteristic curve (AUC), wherein the generic drug is supposed to demonstrate similar ADME activities as the branded drug. The BE studies may be undertaken in vitro (fasting, non-fasting, sprinkled fasting) or in vivo studies (clinical, bioanalytical, and statistical) [ 9 ].

Planning clinical trial/research

The clinical trial process involves protocol development, designing a case record/report form (CRF), and functioning of institutional review boards (IRBs). It also includes data management and the monitoring of clinical trial site activities. The CRF is the most significant document in a clinical study. It contains the information collected by the investigator about each subject participating in a clinical study/trial. According to the International Council for Harmonisation (ICH), the CRF can be printed, optical, or an electronic document that is used to record the safety and efficacy of the pharmaceutical drug/product in the test subjects. This information is intended for the sponsor who initiates the clinical study [ 10 ].

The CRF is designed as per the protocol and later it is thoroughly reviewed for its correctness (appropriate and structured questions) and finalized. The CRF then proceeds toward the print taking the language of the participating subjects into consideration. Once the CRF is printed, it is distributed to the investigation sites where it is filled with the details of the participating subjects by the investigator/nurse/subject/guardian of the subject/technician/consultant/monitors/pharmacist/pharmacokinetics/contract house staff. The filled CRFs are checked for their completeness and transported to the sponsor [ 11 ].

Effective planning and implementation of a clinical study/trial will influence its success. The clinical study majorly includes the collection and distribution of the trial data, which is done by the clinical data management section. The project manager is crucial to effectively plan, organize, and use the best processes to control and monitor the clinical study [ 10 , 11 ].

The clinical study is conducted by a sponsor or a clinical research organization (CRO). A perfect protocol, time limits, and regulatory requirements assume significance while planning a clinical trial. What, when, how, and who are clearly planned before the initiation of a study trial. Regular review of the project using the bar and Gantt charts, and maintaining the timelines assume increased significance for success with the product (study report, statistical report, database) [ 10 , 11 ].

The steps critical to planning a clinical trial include the idea, review of the available literature, identifying a problem, formulating the hypothesis, writing a synopsis, identifying the investigators, writing a protocol, finding a source of funding, designing a patient consent form, forming ethics boards, identifying an organization, preparing manuals for procedures, quality assurance, investigator training and initiation of the trial by recruiting the participants [ 10 ].

The two most important points to consider before the initiation of the clinical trial include whether there is a need for a clinical trial, if there is a need, then one must make sure that the study design and methodology are strong for the results to be reliable to the people [ 11 ].

For clinical research to envisage high-quality results, the study design, implementation of the study, quality assurance in data collection, and alleviation of bias and confounding factors must be robust [ 12 ]. Another important aspect of conducting a clinical trial is improved management of various elements of clinical research that include human and financial resources. The role of a trial manager to make a successful clinical trial was previously reported. The trial manager could play a key role in planning, coordinating, and successfully executing the trial. Some qualities of a trial manager include better communication and motivation, leadership, and strategic, tactical, and operational skills [ 13 ].

Practical aspects of a clinical trial operations

There are different types of clinical research. Research in the development of a novel drug could be initiated by nationally funded research, industry-sponsored research, and clinical research initiated by individuals/investigators. According to the documents 21 code of federal regulations (CFR) 312.3 and ICH E-6 Good Clinical Practice (GCP) 1.54, an investigator is an individual who initiates and conducts clinical research [ 14 ]. The investigator plan, design, conduct, monitor, manage data, compile reports, and supervise research-related regulatory and ethical issues. To manage a successful clinical trial project, it is essential for an investigator to give the letter of intent, write a proposal, set a timeline, develop a protocol and related documents like the case record forms, define the budget, and identify the funding sources.

Other major steps of clinical research include the approval of IRBs, conduction and supervision of the research, data review, and analysis. Successful clinical research includes various essential elements like a letter of intent which is the evidence that supports the interest of the researcher to conduct drug research, timeline, funding source, supplier, and participant characters.

Quality assurance, according to the ICH and GCP guidelines, is necessary to be implemented during clinical research to generate quality and accurate data. Each element of the clinical research must have been carried out according to the standard operating procedure (SOP), which is written/determined before the initiation of the study and during the preparation of the protocol [ 15 ].

The audit team (quality assurance group) is instrumental in determining the authenticity of the clinical research. The audit, according to the ICH and GCP, is an independent and external team that examines the process (recording the CRF, analysis of data, and interpretation of data) of clinical research. The quality assurance personnel are adequately trained, become trainers if needed, should be good communicators, and must handle any kind of situation. The audits can be at the investigator sites evaluating the CRF data, the protocol, and the personnel involved in clinical research (source data verification, monitors) [ 16 ].

Clinical trial operations are governed by legal and regulatory requirements, based on GCPs, and the application of science, technology, and interpersonal skills [ 17 ]. Clinical trial operations are complex, time and resource-specific that requires extensive planning and coordination, especially for the research which is conducted at multiple trial centers [ 18 ].

Recruiting the clinical trial participants/subjects is the most significant aspect of clinical trial operations. Previous research had noted that most clinical trials do not meet the participant numbers as decided in the protocol. Therefore, it is important to identify the potential barriers to patient recruitment [ 19 ].

Most clinical trials demand huge costs, increased timelines, and resources. Randomized clinical trial studies from Switzerland were analyzed for their costs which revealed approximately 72000 USD for a clinical trial to be completed. This study emphasized the need for increased transparency with respect to the costs associated with the clinical trial and improved collaboration between collaborators and stakeholders [ 20 ].

Clinical trial applications, monitoring, and audit

Among the most significant aspects of a clinical trial is the audit. An audit is a systematic process of evaluating the clinical trial operations at the site. The audit ensures that the clinical trial process is conducted according to the protocol, and predefined quality system procedures, following GCP guidelines, and according to the requirements of regulatory authorities [ 21 ].

The auditors are supposed to be independent and work without the involvement of the sponsors, CROs, or personnel at the trial site. The auditors ensure that the trial is conducted by designated professionally qualified, adequately trained personnel, with predefined responsibilities. The auditors also ensure the validity of the investigational drug, and the composition, and functioning of institutional review/ethics committees. The availability and correctness of the documents like the investigational broacher, informed consent forms, CRFs, approval letters of the regulatory authorities, and accreditation of the trial labs/sites [ 21 ].

The data management systems, the data collection software, data backup, recovery, and contingency plans, alternative data recording methods, security of the data, personnel training in data entry, and the statistical methods used to analyze the results of the trial are other important responsibilities of the auditor [ 21 , 22 ].

According to the ICH-GCP Sec 1.29 guidelines the inspection may be described as an act by the regulatory authorities to conduct an official review of the clinical trial-related documents, personnel (sponsor, investigator), and the trial site [ 21 , 22 ]. The summary report of the observations of the inspectors is performed using various forms as listed in Table ​ Table5 5 .

FDA: Food and Drug Administration; IND: investigational new drug; NDA: new drug application; IRB: institutional review board; CFR: code of federal regulations

Because protecting data integrity, the rights, safety, and well-being of the study participants are more significant while conducting a clinical trial, regular monitoring and audit of the process appear crucial. Also, the quality of the clinical trial greatly depends on the approach of the trial personnel which includes the sponsors and investigators [ 21 ].

The responsibility of monitoring lies in different hands, and it depends on the clinical trial site. When the trial is initiated by a pharmaceutical industry, the responsibility of trial monitoring depends on the company or the sponsor, and when the trial is conducted by an academic organization, the responsibility lies with the principal investigator [ 21 ].

An audit is a process conducted by an independent body to ensure the quality of the study. Basically, an audit is a quality assurance process that determines if a study is carried out by following the SPOs, in compliance with the GCPs recommended by regulatory bodies like the ICH, FDA, and other local bodies [ 21 ].

An audit is performed to review all the available documents related to the IRB approval, investigational drug, and the documents related to the patient care/case record forms. Other documents that are audited include the protocol (date, sign, treatment, compliance), informed consent form, treatment response/outcome, toxic response/adverse event recording, and the accuracy of data entry [ 22 ].

Clinical trial data analysis, regulatory audits, and project management

The essential elements of clinical trial management systems (CDMS) include the management of the study, the site, staff, subject, contracts, data, and document management, patient diary integration, medical coding, monitoring, adverse event reporting, supplier management, lab data, external interfaces, and randomization. The CDMS involves setting a defined start and finishing time, defining study objectives, setting enrolment and termination criteria, commenting, and managing the study design [ 23 ].

Among the various key application areas of clinical trial systems, the data analysis assumes increased significance. The clinical trial data collected at the site in the form of case record form is stored in the CDMS ensuring the errors with respect to the double data entry are minimized.

Clinical trial data management uses medical coding, which uses terminologies with respect to the medications and adverse events/serious adverse events that need to be entered into the CDMS. The project undertaken to conduct the clinical trial must be predetermined with timelines and milestones. Timelines are usually set for the preparation of protocol, designing the CRF, planning the project, identifying the first subject, and timelines for recording the patient’s data for the first visit.

The timelines also are set for the last subject to be recruited in the study, the CRF of the last subject, and the locked period after the last subject entry. The planning of the project also includes the modes of collection of the data, the methods of the transport of the CRFs, patient diaries, and records of severe adverse events, to the central data management sites (fax, scan, courier, etc.) [ 24 ].

The preparation of SOPs and the type and timing of the quality control (QC) procedures are also included in the project planning before the start of a clinical study. Review (budget, resources, quality of process, assessment), measure (turnaround times, training issues), and control (CRF collection and delivery, incentives, revising the process) are the three important aspects of the implementation of a clinical research project.

In view of the increasing complexity related to the conduct of clinical trials, it is important to perform a clinical quality assurance (CQA) audit. The CQA audit process consists of a detailed plan for conducting audits, points of improvement, generating meaningful audit results, verifying SOP, and regulatory compliance, and promoting improvement in clinical trial research [ 25 ]. All the components of a CQA audit are delineated in Table ​ Table6 6 .

CRF: case report form; CSR: clinical study report; IC: informed consent; PV: pharmacovigilance; SAE: serious adverse event

Clinical trial operations at the investigator's site

The selection of an investigation site is important before starting a clinical trial. It is essential that the individuals recruited for the study meet the inclusion criteria of the trial, and the investigator's and patient's willingness to accept the protocol design and the timelines set by the regulatory authorities including the IRBs.

Before conducting clinical research, it is important for an investigator to agree to the terms and conditions of the agreement and maintain the confidentiality of the protocol. Evaluation of the protocol for the feasibility of its practices with respect to the resources, infrastructure, qualified and trained personnel available, availability of the study subjects, and benefit to the institution and the investigator is done by the sponsor during the site selection visit.

The standards of a clinical research trial are ensured by the Council for International Organizations of Medical Sciences (CIOMS), National Bioethics Advisory Commission (NBAC), United Nations Programme on Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) (UNAIDS), and World Medical Association (WMA) [ 26 ].

Recommendations for conducting clinical research based on the WMA support the slogan that says, “The health of my patient will be my first consideration.” According to the International Code of Medical Ethics (ICME), no human should be physically or mentally harmed during the clinical trial, and the study should be conducted in the best interest of the person [ 26 ].

Basic principles recommended by the Helsinki declaration include the conduction of clinical research only after the prior proof of the safety of the drug in animal and lab experiments. The clinical trials must be performed by scientifically, and medically qualified and well-trained personnel. Also, it is important to analyze the benefit of research over harm to the participants before initiating the drug trials.

The doctors may prescribe a drug to alleviate the suffering of the patient, save the patient from death, and gain additional knowledge of the drug only after obtaining informed consent. Under the equipoise principle, the investigators must be able to justify the treatment provided as a part of the clinical trial, wherein the patient in the placebo arm may be harmed due to the unavailability of the therapeutic/trial drug.

Clinical trial operations greatly depend on the environmental conditions and geographical attributes of the trial site. It may influence the costs and targets defined by the project before the initiation. It was noted that one-fourth of the clinical trial project proposals/applications submit critical data on the investigational drug from outside the country. Also, it was noted that almost 35% of delays in clinical trials owing to patient recruitment with one-third of studies enrolling only 5% of the participants [ 27 ].

It was suggested that clinical trial feasibility assessment in a defined geographical region may be undertaken for improved chances of success. Points to be considered under the feasibility assessment program include if the disease under the study is related to the population of the geographical region, appropriateness of the study design, patient, and comparator group, visit intervals, potential regulatory and ethical challenges, and commitments of the study partners, CROs in respective countries (multi-centric studies) [ 27 ].

Feasibility assessments may be undertaken at the program level (ethics, regulatory, and medical preparedness), study level (clinical, regulatory, technical, and operational aspects), and at the investigation site (investigational drug, competency of personnel, participant recruitment, and retention, quality systems, and infrastructural aspects) [ 27 ].

Clinical trials: true experiments

In accordance with the revised schedule "Y" of the Drugs and Cosmetics Act (DCA) (2005), a drug trial may be defined as a systematic study of a novel drug component. The clinical trials aim to evaluate the pharmacodynamic, and pharmacokinetic properties including ADME, efficacy, and safety of new drugs.

According to the drug and cosmetic rules (DCR), 1945, a new chemical entity (NCE) may be defined as a novel drug approved for a disease/condition, in a specified route, and at a particular dosage. It also may be a new drug combination, of previously approved drugs.

A clinical trial may be performed in three types; one that is done to find the efficacy of an NCE, a comparison study of two drugs against a medical condition, and the clinical research of approved drugs on a disease/condition. Also, studies of the bioavailability and BE studies of the generic drugs, and the drugs already approved in other countries are done to establish the efficacy of new drugs [ 28 ].

Apart from the discovery of a novel drug, clinical trials are also conducted to approve novel medical devices for public use. A medical device is defined as any instrument, apparatus, appliance, software, and any other material used for diagnostic/therapeutic purposes. The medical devices may be divided into three classes wherein class I uses general controls; class II uses general and special controls, and class III uses general, special controls, and premarket approvals [ 28 ].

The premarket approval applications ensure the safety and effectiveness, and confirmation of the activities from bench to animal to human clinical studies. The FDA approval for investigational device exemption (IDE) for a device not approved for a new indication/disease/condition. There are two types of IDE studies that include the feasibility study (basic safety and potential effectiveness) and the pivotal study (trial endpoints, randomization, monitoring, and statistical analysis plan) [ 28 ].

As evidenced by the available literature, there are two types of research that include observational and experimental research. Experimental research is alternatively known as the true type of research wherein the research is conducted by the intervention of a new drug/device/method (educational research). Most true experiments use randomized control trials that remove bias and neutralize the confounding variables that may interfere with the results of research [ 28 ].

The variables that may interfere with the study results are independent variables also called prediction variables (the intervention), dependent variables (the outcome), and extraneous variables (other confounding factors that could influence the outside). True experiments have three basic elements that include manipulation (that influence independent variables), control (over extraneous influencers), and randomization (unbiased grouping) [ 29 ].

Experiments can also be grouped as true, quasi-experimental, and non-experimental studies depending on the presence of specific characteristic features. True experiments have all three elements of study design (manipulation, control, randomization), and prospective, and have great scientific validity. Quasi-experiments generally have two elements of design (manipulation and control), are prospective, and have moderate scientific validity. The non-experimental studies lack manipulation, control, and randomization, are generally retrospective, and have low scientific validity [ 29 ].

Clinical trials: epidemiological and human genetics study

Epidemiological studies are intended to control health issues by understanding the distribution, determinants, incidence, prevalence, and impact on health among a defined population. Such studies are attempted to perceive the status of infectious diseases as well as non-communicable diseases [ 30 ].

Experimental studies are of two types that include observational (cross-sectional studies (surveys), case-control studies, and cohort studies) and experimental studies (randomized control studies) [ 3 , 31 ]. Such research may pose challenges related to ethics in relation to the social and cultural milieu.

Biomedical research related to human genetics and transplantation research poses an increased threat to ethical concerns, especially after the success of the human genome project (HGP) in the year 2000. The benefits of human genetic studies are innumerable that include the identification of genetic diseases, in vitro fertilization, and regeneration therapy. Research related to human genetics poses ethical, legal, and social issues (ELSI) that need to be appropriately addressed. Most importantly, these genetic research studies use advanced technologies which should be equally available to both economically well-placed and financially deprived people [ 32 ].

Gene therapy and genetic manipulations may potentially precipitate conflict of interest among the family members. The research on genetics may be of various types that include pedigree studies (identifying abnormal gene carriers), genetic screening (for diseases that may be heritable by the children), gene therapeutics (gene replacement therapy, gene construct administration), HGP (sequencing the whole human genome/deoxyribonucleic acid (DNA) fingerprinting), and DNA, cell-line banking/repository [ 33 ]. The biobanks are established to collect and store human tissue samples like umbilical tissue, cord blood, and others [ 34 ].

Epidemiological studies on genetics are attempts to understand the prevalence of diseases that may be transmitted among families. The classical epidemiological studies may include single case observations (one individual), case series (< 10 individuals), ecological studies (population/large group of people), cross-sectional studies (defined number of individuals), case-control studies (defined number of individuals), cohort (defined number of individuals), and interventional studies (defined number of individuals) [ 35 ].

Genetic studies are of different types that include familial aggregation (case-parent, case-parent-grandparent), heritability (study of twins), segregation (pedigree study), linkage study (case-control), association, linkage, disequilibrium, cohort case-only studies (related case-control, unrelated case-control, exposure, non-exposure group, case group), cross-sectional studies, association cohort (related case-control, familial cohort), and experimental retrospective cohort (clinical trial, exposure, and non-exposure group) [ 35 ].

Ethics and concerns in clinical trial/research

Because clinical research involves animals and human participants, adhering to ethics and ethical practices assumes increased significance [ 36 ]. In view of the unethical research conducted on war soldiers after the Second World War, the Nuremberg code was introduced in 1947, which promulgated rules for permissible medical experiments on humans. The Nuremberg code suggests that informed consent is mandatory for all the participants in a clinical trial, and the study subjects must be made aware of the nature, duration, and purpose of the study, and potential health hazards (foreseen and unforeseen). The study subjects should have the liberty to withdraw at any time during the trial and to choose a physician upon medical emergency. The other essential principles of clinical research involving human subjects as suggested by the Nuremberg code included benefit to the society, justification of study as noted by the results of the drug experiments on animals, avoiding even minimal suffering to the study participants, and making sure that the participants don’t have life risk, humanity first, improved medical facilities for participants, and suitably qualified investigators [ 37 ].

During the 18th world medical assembly meeting in the year 1964, in Helsinki, Finland, ethical principles for doctors practicing research were proposed. Declaration of Helsinki, as it is known made sure that the interests and concerns of the human participants will always prevail over the interests of the society. Later in 1974, the National Research Act was proposed which made sure that the research proposals are thoroughly screened by the Institutional ethics/Review Board. In 1979, the April 18th Belmont report was proposed by the national commission for the protection of human rights during biomedical and behavioral research. The Belmont report proposed three core principles during research involving human participants that include respect for persons, beneficence, and justice. The ICH laid down GCP guidelines [ 38 ]. These guidelines are universally followed throughout the world during the conduction of clinical research involving human participants.

ICH was first founded in 1991, in Brussels, under the umbrella of the USA, Japan, and European countries. The ICH conference is conducted once every two years with the participation from the member countries, observers from the regulatory agencies, like the World Health Organization (WHO), European Free Trade Association (EFTA), and the Canadian Health Protection Branch, and other interested stakeholders from the academia and the industry. The expert working groups of the ICH ensure the quality, efficacy, and safety of the medicinal product (drug/device). Despite the availability of the Nuremberg code, the Belmont Report, and the ICH-GCP guidelines, in the year 1982, International Ethical Guidelines for Biomedical Research Involving Human Subjects was proposed by the CIOMS in association with WHO [ 39 ]. The CIOMS protects the rights of the vulnerable population, and ensures ethical practices during clinical research, especially in underdeveloped countries [ 40 ]. In India, the ethical principles for biomedical research involving human subjects were introduced by the Indian Council of Medical Research (ICMR) in the year 2000 and were later amended in the year 2006 [ 41 ]. Clinical trial approvals can only be done by the IRB approved by the Drug Controller General of India (DGCI) as proposed in the year 2013 [ 42 ].

Current perspectives and future implications

A recent study attempted to evaluate the efficacy of adaptive clinical trials in predicting the success of a clinical trial drug that entered phase 3 and minimizing the time and cost of drug development. This study highlighted the drawbacks of such clinical trial designs that include the possibility of type 1 (false positive) and type 2 (false negative) errors [ 43 ].

The usefulness of animal studies during the preclinical phases of a clinical trial was evaluated in a previous study which concluded that animal studies may not completely guarantee the safety of the investigational drug. This is noted by the fact that many drugs which passed toxicity tests in animals produced adverse reactions in humans [ 44 ].

The significance of BE studies to compare branded and generic drugs was reported previously. The pharmacokinetic BE studies of Amoxycillin comparing branded and generic drugs were carried out among a group of healthy participants. The study results have demonstrated that the generic drug had lower Cmax as compared to the branded drug [ 45 ].

To establish the BE of the generic drugs, randomized crossover trials are carried out to assess the Cmax and the AUC. The ratio of each pharmacokinetic characteristic must match the ratio of AUC and/or Cmax, 1:1=1 for a generic drug to be considered as a bioequivalent to a branded drug [ 46 ].

Although the generic drug development is comparatively more beneficial than the branded drugs, synthesis of extended-release formulations of the generic drug appears to be complex. Since the extended-release formulations remain for longer periods in the stomach, they may be influenced by gastric acidity and interact with the food. A recent study suggested the use of bio-relevant dissolution tests to increase the successful production of generic extended-release drug formulations [ 47 ].

Although RCTs are considered the best designs, which rule out bias and the data/results obtained from such clinical research are the most reliable, RCTs may be plagued by miscalculation of the treatment outcomes/bias, problems of cointerventions, and contaminations [ 48 ].

The perception of healthcare providers regarding branded drugs and their view about the generic equivalents was recently analyzed and reported. It was noted that such a perception may be attributed to the flexible regulatory requirements for the approval of a generic drug as compared to a branded drug. Also, could be because a switch from a branded drug to a generic drug in patients may precipitate adverse events as evidenced by previous reports [ 49 ].

Because the vulnerable population like drug/alcohol addicts, mentally challenged people, children, geriatric age people, military persons, ethnic minorities, people suffering from incurable diseases, students, employees, and pregnant women cannot make decisions with respect to participating in a clinical trial, ethical concerns, and legal issues may prop up, that may be appropriately addressed before drug trials which include such groups [ 50 ].

Conclusions

Clinical research and clinical trials are important from the public health perspective. Clinical research facilitates scientists, public health administrations, and people to increase their understanding and improve preparedness with reference to the diseases prevalent in different geographical regions of the world. Moreover, clinical research helps in mitigating health-related problems as evidenced by the current Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) pandemic and other emerging and re-emerging microbial infections. Clinical trials are crucial to the development of drugs, devices, and vaccines. Therefore, scientists are required to be up to date with the process and procedures of clinical research and trials as discussed comprehensively in this review.

The content published in Cureus is the result of clinical experience and/or research by independent individuals or organizations. Cureus is not responsible for the scientific accuracy or reliability of data or conclusions published herein. All content published within Cureus is intended only for educational, research and reference purposes. Additionally, articles published within Cureus should not be deemed a suitable substitute for the advice of a qualified health care professional. Do not disregard or avoid professional medical advice due to content published within Cureus.

The authors have declared that no competing interests exist.

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Medical research articles within Nature

News & Views | 18 September 2024

Gut microbes fend off harmful bacteria by depriving them of nutrients

Microorganisms that normally reside in the gut can help to block microbial infection. A group of bacteria that lives in the human gut has been identified that can consume a nutrient needed by pathogenic bacteria.

• Eric G. Pamer

News Explainer | 17 September 2024

Should young kids take the new anti-obesity drugs? What the research says

Evidence shows that blockbuster weight-loss medications can reduce obesity even in children aged 6–11 years, but their long-term effects on growing bodies are unknown.

• Julian Nowogrodzki

News Feature | 17 September 2024

Doctors cured her sickle-cell disease. So why is she still in pain?

Gene and cell therapies bring fresh hope to people with genetic disorders, but recovery can be complex and long-term support remains sparse.

• Heidi Ledford

News & Views | 11 September 2024

Long-lasting heart-failure treatment could be a game-changer

Boosting the heart’s natural countermeasures against poor function is one way to treat heart failure, but existing therapies need to be given frequently. An antibody with enduring effects could offer a solution.

• John C. Burnett Jr

Lipid recycling by macrophage cells drives the growth of brain cancer

In brain tumours, immune cells called macrophages scavenge lipid debris from the myelin sheath of neurons. These lipid-laden macrophages cause immunosuppression, and their transfer of lipids to tumours fuels cancer growth.

• Lisa Sevenich

News | 11 September 2024

Why some women enter menopause early — and how that could affect their cancer risk

Genomic analysis reveals a host of genetic variants that affect how quickly fertility ends, among them one that reduces reproductive span by six years.

Nature Podcast | 11 September 2024

Ancient DNA debunks Rapa Nui ‘ecological suicide’ theory

Study refutes claim that mismanagement of natural resources led to population crash — plus a tiny wasp that’s been found in an unexpected place.

• Benjamin Thompson
•  &  Nick Petrić Howe

Correspondence | 10 September 2024

Artificial intelligence can help to make animal research redundant

• Calvin Drakos
• , Vineesha Manimangalam
•  &  Ozlem Equils

Update regulator guidance to show that animal research really is no longer king

• Lindsay Marshall
• , Rebecca Simmons
•  &  Greg Sower

The pharmaceutical industry must embrace synthetic alternatives to horseshoe-crab blood

•  &  Lawrence Niles

World View | 10 September 2024

Europe sidelines Alzheimer’s drug: lessons must be learnt

If the European Medicines Agency takes an overly cautious approach to selecting specialists to advise on new medicines, people could be left without treatments.

• Henrik Zetterberg

News | 09 September 2024

World’s first whole-eye transplant: the innovations that made it possible

The first face transplant to also include an eyeball was a surgical coup — but restoring vision remains a challenge.

News | 05 September 2024

Transparent mice made with light-absorbing dye reveal organs at work

A method that renders skin temporarily see-through could offer researchers a non-invasive way to look inside the bodies of live mice.

• Jude Coleman

News & Views | 04 September 2024

Breast cancer blocked by multiple natural lines of defence

Cancer-promoting mutations are common in healthy tissue but rarely lead to tumour formation. A study of the mouse mammary gland reveals three protective mechanisms that limit the ability of cells to give rise to cancer.

• Biancastella Cereser

The immune system of trans men reveals how hormones shape immunity

What drives sex biases in the immune system? Examining how gender-affirming therapy affects the molecular profiles of immune cells of trans men reveals how hormones underpin immune responses.

• Margaret M. McCarthy

Article 04 September 2024 | Open Access

Immune system adaptation during gender-affirming testosterone treatment

Examination of immunological changes in transgender individuals undergoing gender-affirming testosterone treatment reveals sex hormone-regulated pathways in humans and explains sex-divergent responses in cisgender individuals.

• Tadepally Lakshmikanth
• , Camila Consiglio
•  &  Petter Brodin

World View | 03 September 2024

African scientists must not be priced out of mental-health research

Under-representation of African populations in mental-health studies perpetuates inequities — change is needed.

• Vivien Chebii

News & Views | 03 September 2024

Skull bones harbour immune cells that are poised to target brain tumours

The human brain is usually considered to be beyond the reach of most immune cells. However, analysis of people who have brain tumours has revealed tumour-targeting T cells of the immune system in skull bones near the cancer site.

•  &  Justin D. Lathia

News | 03 September 2024

How rival weight-loss drugs fare at treating obesity, diabetes and more

Wegovy, Zepbound and similar medications all lead to metabolic improvements, but scientists are starting to unpick the differences between them.

• Mariana Lenharo

News & Views | 28 August 2024

People who lack the immune protein TNF can still fight infection

The immune-signalling protein TNF has an essential role in inflammatory responses. Two people who were found to have no functional TNF are surprisingly healthy and able to fend off most infections, but are susceptible to tuberculosis.

• Charlie J. Pyle
•  &  David M. Tobin

Article 28 August 2024 | Open Access

Fate induction in CD8 CAR T cells through asymmetric cell division

We show that target-induced proximity labelling enables isolation of first-division CD8 chimeric antigen receptor T cells that asymmetrically distribute their surface proteome and transcriptome, resulting in distinct phenotypic, metabolic and functional profiles in proximal and distal daughter cells.

• Casey S. Lee
• , Sisi Chen
•  &  Christoph T. Ellebrecht

Correspondence | 27 August 2024

Urgently clarify how AI can be used in medicine under new EU law

• Thomas J. Hwang
•  &  Prokar Dasgupta

News | 22 August 2024

Debate rages over Alzheimer’s drug lecanemab as UK limits approval

The medicine is being assessed by agencies including the European Union regulator, but the community is divided on its efficacy and safety.

Book Review | 21 August 2024

Forever young: what science can and can’t tell us about cheating ageing

High-profile advances, such as anti-ageing drugs called senolytics, have sparked hope that old age and death could be postponed considerably, and have even fostered fantasies of eternal life. But the reality is more nuanced.

• Jan H. J. Hoeijmakers

News Feature | 21 August 2024

The testing of AI in medicine is a mess. Here’s how it should be done

Hundreds of medical algorithms have been approved on basis of limited clinical data. Scientists are debating who should test these tools and how best to do it.

Career Feature | 20 August 2024

Whistleblowing in science: this physician faced ostracization after standing up to pharma

Physician scientist Nancy Olivieri describes hard-won lessons from decades of fighting for scientific integrity.

• Sara Reardon

Research Highlight | 16 August 2024

Child with ultra-rare disease gets a treatment just for her

Therapy designed for one seems to have improved a young girl’s quality of life.

News | 16 August 2024

Hopes dashed for drug aimed at monkeypox virus spreading in Africa

Early results from clinical trial show that the antiviral drug tecovirimat is no better than placebo against the clade I virus type.

The mysteries of inflammatory bowel disease are being cracked — offering hope for new therapies

Advances in understanding the causes of the autoimmune disorder could aid in matching people with the right treatment.

News | 14 August 2024

How a trove of cancer genomes could improve kids’ leukaemia treatment

Analysis shows that a type of fast-growing paediatric cancer has 15 distinct subtypes, each linked to responsiveness to particular therapies.

• Giorgia Guglielmi

Nature Podcast | 14 August 2024

The mystery of Stonehenge’s central stone unearthed

A geochemical analysis suggests that Stonehenge’s Altar Stone came from northern Scotland — plus, chemists have finally discovered how to break selenium bonds unevenly.

• Nick Petrić Howe
•  &  Dan Fox

One-quarter of unresponsive people with brain injuries are conscious

More people than we thought who are in comas or similar states can hear what is happening around them, a study shows.

Research Highlight | 07 August 2024

Engineered brain parasite ferries useful proteins into neurons

Microbe found in cat poo could be harnessed to deliver large, complex proteins across the blood–brain barrier.

News | 07 August 2024

Breast-cancer cells enlist nerves to spread throughout the body

Surprising results show that ‘sensory’ nerves, which carry information to the brain, have a direct role in helping tumours to metastasize.

News Feature | 07 August 2024

Blood tests could soon predict your risk of Alzheimer’s

Scientists are closing in on biomarkers that reflect the progression of Alzheimer’s disease and could improve treatments.

• Alison Abbott

Article 07 August 2024 | Open Access

DNA-sensing inflammasomes cause recurrent atherosclerotic stroke

This study describes sensing of circulating cell-free DNA after stroke as the mechanism leading to recurrent ischemic events.

• , Stefan Roth
•  &  Arthur Liesz

The genomic landscape of 2,023 colorectal cancers

Whole-genome sequencing of more than 2,000 colorectal carcinoma samples provides a highly detailed view of the genomic landscape of this cancer and identifies new driver mutations.

• Alex J. Cornish
• , Andreas J. Gruber
•  &  Richard S. Houlston

Obituary | 25 July 2024

V. Craig Jordan obituary: pharmacologist who revolutionized breast cancer treatments

Pioneer of targeted therapy in cancer who turned failed contraceptive tamoxifen into an essential drug for treating breast cancer and osteoporosis.

• Balkees Abderrahman

News & Views | 24 July 2024

Cancer spread in the liver is unlocked from within

How spreading tumour cells gain the ability to grow in organs away from where they originated is not fully understood. The discovery that normal liver cells help invading tumour cells to thrive in this organ sheds light on this process.

• Katharina Woess
•  &  Direna Alonso-Curbelo

Article 17 July 2024 | Open Access

Psilocybin desynchronizes the human brain

Healthy adults were tracked before, during and after high doses of psilocybin and methylphenidate to assess how psychedelics can change human brain networks, and psilocybin was found to massively disrupt functional connectivity in cortex and subcortex with some changes persisting for weeks.

• Joshua S. Siegel
• , Subha Subramanian
•  &  Nico U. F. Dosenbach

Correspondence | 16 July 2024

Abandoning randomized controlled trials won’t help cancer treatment

• Lorenzo Fornaro
•  &  Francesco Crea

News & Views | 16 July 2024

The death forecast: how weather affects human mortality

A link between the death rate and summer temperatures, and Lord Kelvin’s scientific achievements celebrated, in our weekly dip into Nature’s archive.

Outlook | 11 July 2024

Saliva-based tests offer an alternative to nasal swabbing

Drooling into a tube is not only more comfortable than nasal testing, it could also detect disease earlier.

• Neil Savage

Nature Podcast | 10 July 2024

Breastfeeding should break down mothers’ bones — here’s why it doesn’t

A hormone discovered in mice could help keep bones healthy during lactation, and a new way to edit genes in the gut microbiome.

News | 10 July 2024

How anti-obesity drugs cause nausea: finding offers hope for better drugs

The neurons that produce a sick feeling and food aversion are distinct from those that induce a feeling of fullness.

Article 10 July 2024 | Open Access

Repeated plague infections across six generations of Neolithic Farmers

Population-scale ancient genomics are used to infer ancestry, social structure and pathogen infection in 108 Scandinavian Neolithic individuals from eight megalithic graves and a stone cist, showing that Neolithic plague was widespread.

• Frederik Valeur Seersholm
• , Karl-Göran Sjögren
•  &  Martin Sikora

Research Highlight | 04 July 2024

AI tool can pinpoint dementia’s cause — from stroke to Alzheimer’s

Algorithm that distinguishes among a host of underlying causes of dementia could be used for diagnosis in hospitals and clinics.

News | 01 July 2024

Bionic leg moves like a natural limb — without conscious thought

Computer interface links signals from the brain to an artificial limb, giving the wearer better balance, flexibility and speed.

• Miryam Naddaf

News | 20 June 2024

Gut microbiome discovery provides roadmap for life-saving cancer therapies

The balance between bacterial communities in the gut affects the likelihood of a positive response to drugs called checkpoint inhibitors.

Editorial | 19 June 2024

Human neuroscience is entering a new era — it mustn’t forget its human dimension

The field is taking a leap forward thanks to innovative technologies, such as artificial intelligence. Researchers must improve consent procedures and public involvement.

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• Peer review

In this research review by Tom Nolan ( BMJ 2024;386:q1967, doi: 10.1136/bmj.q1967 , published 12 September 2024), wrongly referred to “glucagon-like peptide-1 (GLP-1) receptor antagonists, such as semaglutide and liraglutide.” The drugs are glucagon-like peptide-1 (GLP-1) receptor agonists. The article has now been corrected.

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Published Clinical Research Conducted at the Clinical Center in 2020

Here is a sample of abstracts from the clinical research conducted at the NIH Clinical Center and published in a peer reviewed medical journal in 2020. Links to the full text and video formats are provided if available.

Prisons and Pandemics

Published in: San Diego Law Review (December 2020)

The COVID-19 pandemic has ravaged U.S. prisons and jails, leading to heated debates about early release of prisoners. This article discusses how to balance protection of public health, public safety, and incarcerated individuals’ legal rights during a pandemic.

Read the article .

Real-World Inpatient Use of Medications Repurposed for COVID-19 in U.S. Hospitals, March-May 2020

Published in: Open Forum Infectious Diseases (December 2020)

In times of medical emergencies, medical care may be greatly influenced by suboptimal evidence, mass media, and experiences from similar and non-scientific clinical scenarios coupled with the need to “do something”, especially for severely ill patients.

Pooled Saliva Specimens for SARS-CoV-2 Testing

Published in: Journal of Clinical Microbiology (December 2020)

Saliva testing can detect individuals with higher viral loads and more likely infectious. In asymptomatic screening, it does not require swabs or viral transport media for collection, and may help improve voluntary screening compliance for those averse to nasal collections.

COVID-19: Risk of Infection Is High, Independently of ABO Blood Group

Published in: Haematologica (December 2020)

The risk of acquiring a SARS-CoV-2 infection is exceptionally high among young adults exposed to the virus in certain circumstances and no ABO blood group type can protect an individual from becoming infected.

N-Glycan Modification in Covid-19 Pathophysiology: In vitro Structural Changes with Limited Functional Effects

Published in: Journal of Clinical Immunology (November 2020)

Despite clear N-glycan alteration in the presence of miglustat, an FDA-approved α-glucosidase inhibitor, the function of the Covid-19-related glycoproteins studied was not affected, making it unlikely that miglustat can change the natural course of the disease.

Exercise Intervention Leads to Functional Improvement in a Patient with Spinal and Bulbar Muscular Atrophy

Published in: Journal of Rehabilitation Medicine (November 2020)

A patient with the progressive neuromuscular disease of spinal and bulbar muscular atrophy experiences improvement in multiple clinical measures of strength and function after adhering to a minimally supervised home-based exercise program.

In Utero SARS-CoV-2 Infection

Published in: Journal of the Pediatric Infectious Diseases Society (October 2020)

A premature child born with viral RNA in the cord blood, urine and nasopharynx provides evidence of in utero transmission of SARS-CoV-2 and provides insight into bloodstream spread from mother to fetus.

Cooking Frequency and Perception of Diet among US Adults Are Associated with US Healthy and Healthy Mediterranean-Style Dietary Related Classes: A Latent Class Profile Analysis

Published in: Nutrients (October 2020)

Cooking frequency, as a dietary behavior, may be a potential area of focus for dietary quality promotion efforts directed at helping Americans adhere to recommended dietary guidelines.

How Low Should We Go? Potential Benefits and Ramifications of the Pulmonary Hypertension Hemodynamic Definitions Proposed by the 6th World Symposium

Published in: Current Opinion in Pulmonary Medicine (September 2020)

Review of the historical context of the hemodynamic criteria that define pulmonary hypertension as well as the literature supporting the proposal by the 6th World Symposium on Pulmonary Hypertension to lower the threshold of mean pulmonary artery pressure.

So Much at Stake: Ethical Tradeoffs in Accelerating SARSCoV-2 Vaccine Development

Published in: Vaccine (September 2020)

Accelerated randomized controlled trials are the best approach to accelerating vaccine development in a pandemic, and more likely than other approaches to enhance social value without compromising ethics or science.

Watch the video . Read the article .

Dacron Swab and PBS Are Acceptable Alternatives to Flocked Swab and Viral Transport Media for SARS-CoV-2

Published in: Diagnostic Microbiology and Infectious Diseases (September 2020)

Nasopharyngeal flocked swabs in viral transport media are recommended for respiratory virus testing; supplies have become limiting during the coronavirus pandemic. We show that widely available Dacron polyester swabs and phosphate-buffered-saline are an acceptable alternative for SARS-COV-2 and RSV testing.

Artificial Intelligence for the Detection of COVID-19 Pneumonia on Chest CT Using Multinational Datasets

Published in: Nature Communications (August 2020)

A deep learning-based artificial intelligence system can assess computed tomography scans to identify COVID-19 associated pneumonia and distinguish non-COVID related pneumonias with high specificity in diverse patient populations.

Is This Person with Dementia (Currently) Competent to Request Euthanasia? A Complicated and Underexplored Question

Published in: Journal of Medical Ethics (August 2020)

Ethical challenges and implications are explored of determining if a person in a mild to moderately severe stage of dementia, who does not have a written advance euthanasia directive, has the capacity to request euthanasia and/or assisted suicide.

Effect of a Brief Mindfulness-Based Program on Stress in Health Care Professionals at a US Biomedical Research Hospital

Published in: JAMA Network Open (August 2020)

A brief course of mindfulness training during work hours was feasible and effective in reducing stress among a mixed group of health care professionals. The training was also effective in reducing anxiety and improving positive affect, state mindfulness, and self-care.

Time Course and Diagnostic Utility of NfL, tau, GFAp, and UCH-L1 in Subacute and Chronic TBI

Published in: Neurology (July 2020)

Neurofilament light chain delivered superior diagnostic and prognostic performance as a blood biomarker for mild, moderate, and severe traumatic brain injury when compared to blood proteins glial fibrillary acidic protein, tau, and ubiquitin c-terminal hydrolase-L1.

Neurofilament Light as a Biomarker in Traumatic Brain Injury

Neurofilament light chain as a blood biomarker can detect brain injury and predict recovery in multiple groups, including professional hockey players with acute or chronic concussions and clinic-based patients with mild, moderate, or severe traumatic brain injury.

Advantages of Using Lotteries to Select Participants for High‐Demand Covid‐19 Treatment Trials

Published in: Ethics and Human Research (June 2020)

With few treatments available for Covid-19, clinical trials may be attractive for patients but unable to accommodate everyone who wants to enroll. In high-demand trials, a weighted lottery can select participants fairly and efficiently while enhancing the knowledge gained.

Smartphone Augmented Reality CT-Based Platform for Needle Insertion Guidance: A Phantom Study

Published in: CardioVascular and Interventional Radiology (May 2020)

A smartphone application was used to superimpose computer generated images onto patients to test for improvements in needle placement for biopsy or ablation. The video-game-like augmented reality improved accuracy in a variety of phantoms.

Targeted Early Chest CT in COVID-19 Outbreaks as Diagnostic Tool for Containment of the Pandemic - A Multinational Opinion

Published in: Diagnostic and Interventional Radiology (April 2020)

Researchers provide a four-nation opinion on the early use of chest CT scans as a testing tool for focal outbreaks to facilitate containment of COVID-19 and also introduce a new patient isolation bag to reduce CT contamination.

Diversity and Complexity of the Large Surface Protein Family in the Compacted Genomes of Multiple Pneumocystis Species

Published in: MBio (March 2020)

An in-depth analysis on the large surface glycoprotein superfamily in the genomes of Pneumocystis species, a major cause of disease in humans with immunodeficiency, sheds new light on how this pathogen interacts with and survives in the host.

Automated CT Biomarkers for Opportunistic Prediction of Future Cardiovascular Events and Mortality in an Asymptomatic Screening Population

Published in: The Lancet Digital Health (March 2020)

Computerized x-ray imaging often contains unused biometric data that artificial intelligence can access and analyze to predict major cardiovascular events including heart attack, stroke, and death and overall survival with higher accuracy than routine clinical examinations.

A Machine Learning Algorithm to Estimate Sarcopenia on Abdominal CT

Published in: Academic Radiology (March 2020)

A prototype of a fully-automated deep learning system to detect central sarcopenia using computed tomography scans was successfully created and validated.

COVID-19: Growing Health Disparity Gaps and an Opportunity for Health Behavior Discovery?

Published in: Health Equity (February 2020)

Identifying the role of COVID-19 on health behaviors could be key to understanding the pandemic’s impact on populations affected by health disparities, such as African Americans.

Checkpoint Inhibitor Therapy in Preclinical Sepsis Models: a Systematic Review and Meta-Analysis

Published in: Intensive Care Medicine Experimental (February 2020)

AA meta-analysis of 11 animal studies suggest that additional preclinical studies are needed to show the benefit that checkpoint inhibitors add to antibiotic therapy for common bacterial infections causing sepsis.

Spirituality Among Family Caregivers of Cancer Patients: The Spiritual Perspective Scale

Published in: Research in Nursing & Health (January 2020)

This study indicates that the Spiritual Perspective Scale is a viable tool to assess differences in spirituality among informal caregivers of cancer patients.

Sleep Regularity Index in Patients with Alcohol Dependence: Daytime Napping and Mood Disorders as Correlates of Interest

Published in: International Journal of Environmental Research and Public Health (January 2020)

The Sleep Regularity Index was calculated among patients with alcohol use disorder undergoing inpatient treatment and showed associations between the index, the presence of one or more mood disorders, and nap durations.

Chronic Mirabegron Treatment Increases Human Brown Fat, HDL Cholesterol, and Insulin Sensitivity

Published in: Journal of Clinical Investigation (January 2020)

A small study of healthy women treated for four weeks with a beta 3 adrenergic receptor agonist showed increases in metabolic activity of brown fat, HDL-cholesterol, insulin sensitivity, and bile acids, which help digest fats and regulate cholesterol.

Ebola Virus in the Democratic Republic of the Congo: Advances and Remaining Obstacles in Epidemic Control, Clinical Care, and Biomedical Research

Published in: Chest (January 2020)

The Ebola virus disease epidemic in the Congo remains uncontrolled with a high fatality rate despite advances in vaccine availability and use, improved clinical care within Ebola treatment units, and implementation of a research clinical trial evaluating targeted therapies.

Read more articles about research in the NIH Clinical Center in 2020.

Graduate student’s love of science leads to prestigious national fellowship

Kaylee Petraccione receives a National Institute of Health award to study a virus with pandemic potential.

• Felicia Spencer

17 Sep 2024

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Kaylee Petraccione lost her hearing after a vaccination in 2021, but maintains a passion for pursuing research that may one day help rationally design a new vaccine. And it’s led to her winning a national-level grant.

“I got a vaccine booster before the semester started, and within a very short period of time I developed a full body rash and really bad tinnitus,” said Petraccione, a doctoral student studying biomedical and veterinary sciences. “I went to bed and woke up at 5 the next morning screaming because I couldn’t hear anything. When you wake up deaf, it’s really scary and terrifying.”

Today, Petraccione is focused on understanding the molecular mechanisms enabling the Rift Valley fever virus to cause disease. In July, this work earned her the Ruth L. Kirschstein National Research Service Award Individual Predoctoral Fellowship to Promote Diversity in Health-Related Research award from the National Institute of Health (NIH).

“NIH F31 fellowships are extremely competitive and prestigious awards,” said Kylene Kehn-Hall, professor of biomedical sciences and pathobiology and Petraccione’s mentor. “Kaylee being awarded this fellowship speaks to her excellence as a candidate and the quality of her research. This is an enormous accomplishment, and I am extremely proud of her.”  

According to the NIH, the goal of the award is to enhance diversity of scientists for research careers in the biomedical, behavioral, and clinical sciences, including those with disabilities and those from disadvantaged backgrounds. For Petraccione, the grant will support her ultimate goal of closing the knowledge gap regarding the viral pathogenesis of the disease to enable some form of therapeutic intervention or vaccine.

Petraccione said there is currently no Food and Drug Administration-approved treatment or vaccine for the Rift Valley fever virus, which is endemic to sub-Saharan Africa and currently spreading to the Arabian Peninsula. The virus is transmitted through mosquito bites and can spread through aerosol particles or contact with bodily tissues or fluids from an infected person or animal.

Since the virus was identified in the Rift Valley of Kenya in 1931, herds of livestock have been infected, causing health and economic hardships. In livestock, severe infections result in nearly 100 percent death rates in the young, almost 100 percent rates of abortions in pregnant females, and a 20 to 30 percent death rate in adults. In humans, severe cases can cause hemorrhagic fever and encephalitis in less than 2 percent of those infected, yet most people recover within a week of infection.

“The mosquitoes in the U.S. and Europe are competent to carry this virus, so it’s very easy for this virus to spread here, and it’s a high priority pathogen concern of the U.S. government and the World Health Organization,” said Petraccione, who is an affiliate member of the Infectious Disease Interdisciplinary Graduate Education Program . “All it would take is for an infected animal to come here on a boat, and then all of a sudden the mosquitoes start carrying the virus and it will wipe out our herds too. The virus is so dangerous I have to wear a powered air purifying respirator to protect myself.”

Petraccione’s desire to help others has been a driving force ever since she began her post secondary education at Coastal Carolina University. Originally from Schenectady, New York, Petraccione discovered her love for molecular biology and research with a professor who was a Virginia Tech graduate. 

“Neither of my parents have a four-year degree,” Petraccione, who began her Ph.D. in Virginia Tech’s Molecular and Cellular Biology Graduate Program in August 2021. “I push myself to be the best that I can be because I want to better myself and my future, and my family as well.” 

Because of her own challenges, Petraccione is passionate about incorporating outreach into her career, and she already has a head start. 

“I went into a local low-income school to teach preschoolers and kindergartners about viruses,” Petraccione said. “I made a little 3D model of the virus I work with and had them pass it around to learn about transmission and how fast virus systems spread and how to prevent giving each other viruses.”

Petraccione plans to stay in academia and pursue a postdoctoral position where she can continue to help others.

Lindsey Haugh

• Biomedical and Veterinary Sciences
• Center for Emerging, Zoonotic, and Arthropod-borne Pathogens
• College of Science
• Disease Prevention
• Fralin Life Sciences Institute
• Graduate Education
• Graduate Research
• Infection and Immunology
• Reduce Inequalities
• Virginia-Maryland College of Veterinary Medicine

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September 17, 2024

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Parents are stressed. Here's what we can do to help them

by Andrea Gonzalez, The Conversation

Parents are stressed and it is time to do something about it. In a nutshell, that's the message from the United States Surgeon General's recent public health advisory on the mental health and well-being of parents .

The report states that parents and caregivers often face heightened stress due to financial strain, concerns over children's health and safety, isolation and loneliness, and difficulty managing technology and social media .

In a 2023 Pew Research Center report , over a quarter of American parents indicated that being a parent is a lot harder than they expected, with a further third of parents reporting it was somewhat harder than expected.

This news is likely unsurprising to the 6 million Canadian families with children . Despite the overwhelming number of parenting books, blogs, apps and websites, many feel largely unprepared to parent.

The U.S. report should be a call to action to provide parents with the help they need to care for themselves and their families.

Why is parenting stressful?

Parenting is likely harder than expected because, alongside keeping children safe, meeting their needs, time constraints and financial worries, modern families face exacerbated pressures and new stressors.

Today in Canada, two-thirds of mothers work full-time while continuing to take on a larger share of physical household tasks and being more likely to take care of aging parents . Some parents, particularly those who face economic, social and cultural barriers, may carry a greater burden of care-giving stress.

Over the past 40 years, fathers' roles have changed too. There is a higher proportion of families with dads as the stay-home parent ; one in 10 in 2015, compared to one in 70 in 1976. Similarly, fathers have increased participation in domestic tasks (76 percent in 2015 compared to 51 percent in 1986) and time spent on primary child care (49 percent in 2015 compared to 33 percent in 1986).

New parenting stressors include the rise in youth mental health conditions . There are also the difficulties of navigating and negotiating the ever-changing landscape of technology and social media with children , including increasing concerns about safety and impact on child health . That's coupled with the growing costs of child care and strained finances due to inflation.

Reducing parent stress

Although stressors vary across families and child developmental stages, there are many common parenting struggles, including financial issues , balancing routines and schedules, navigating technology and managing mental health concerns for themselves and their children.

To reduce parental stress and promote the well-being of both caregivers and children, we need effective policies, enhanced programs and cultural shifts. Public health campaigns addressing these challenges increase awareness and decrease stigma associated with parenting challenges.

All messages need to sensitively address ethnic, linguistic and socioeconomic diversity.

My research team at McMaster University is currently working on developing resources, building off the innovative materials created by colleagues at Oxford University to assist parents globally during the COVID-19 pandemic.

A recent survey from the U.S. found that two-thirds of parents report feeling lonely and isolated. Almost 80 percent of parents surveyed also indicated they would value having a way to connect with other parents outside of work and home. Building supportive networks where parents can connect with each other go a long way toward addressing those feelings.

Collective action is needed to provide opportunities where parents and caregivers can meet to share perspectives and insights and support one another.

Providing such opportunities in places like community groups, workplaces, schools, faith organizations and health and social support systems can help eliminate common barriers to access and promote engagement (for example, brief seminars to discuss important parenting issues with parents).

Some policy recommendations

In Canada, more can be done at all levels of government to support parents, caregivers and their families. Policymakers should enhance financial assistance programs such as the Canada Child Benefit and Child Disability Benefit .

Although progress has been made towards child-care support , accessibility issues in terms of the availability and affordability of high-quality programs continue to be an issue for many parents.

Too many families are struggling to meet their basic needs, which contributes to parenting stress and negatively impacts mental health. Expanded funding and resources should be prioritized for food and housing security, and prevention of adverse childhood experiences. The 2022 Report of the National Advisory Council on Poverty provides many strategies that governments should enact to support parents and caregivers.

Although most provinces and territories provide online support to connect families to services, navigating complex needs across organizations and services can be challenging and confusing. Governments should develop unified ways to access social and health services.

Accessible and affordable high-quality mental health care is needed for parents and caregivers. This involves supporting telehealth options; reducing wait times by expanding and supporting the mental health workforce and community mental health-care options; and strengthening publicly funded coverage.

Although the counterargument of cost is invariably raised, it has been proven that cost-effective prevention and treatment strategies save future dollars in health care costs and lost productivity with substantial benefits to society .

Parental mental health supports must be integrated into primary care, child mental health services and schools. Due to siloed government funding, supports are currently provided by separate service delivery systems, limiting our ability to adopt two generation family approaches .

One way to do this is to embed social workers, mental health providers or peer support specialists within pediatric, primary-care facilities and schools.

Touchpoints with health-care systems (vaccination, wellness and annual visits) can be leveraged to check in with parents and caregivers about their stress, sleep and mental health and provide information about childhood milestones and changes across development and strategies for parenting and overall well-being. Social service and educational systems can similarly provide resources to families.

Resources for parents

If you're a parent or caregiver in need of assistance for yourself or your child, help is available. The Canadian Mental Health Association provides various resources and supports for families

Kids Help Phone is available 24-7 for children and youth. Parents can also reach out for advice or to access online resources. You can call them toll-free at 1-800-668-6868 or text CONNECT to 686868.

Families Canada also provides a comprehensive overview of family support centers across Canada.

The U.S. Surgeon General's advisory on parenting stress was a wake-up call, highlighting what we need to do to support parents. This involves all of us—family members, friends, co-workers, employers, professionals, educators and policymakers.

Raising a child is not easy, and at the risk of sounding colloquial, it really does take a village.

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Cannabis commission research chief takes medical leave after alleging ‘inappropriate’ and ‘harmful’ behaviors by leaders

Julie k. johnson’s leave, for what she called job-related post-traumatic stress, adds to vacancies and turmoil at the commission..

The state Cannabis Control Commission’s research chief said Tuesday she will take medical leave for job-related post-traumatic stress, just days after she penned a public letter alleging she had experienced “inappropriate” and “harmful” behavior from senior leaders.

It’s the latest of many recent personnel moves at the commission that have forced lawmakers and industry observers to question how the agency can move forward with its day-to-day functions regulating the state’s $7 billion cannabis industry. The Legislature plans to hold hearings this fall to revisit the structure and issues within the commission after calls for receivership surfaced this summer.

The commission is operating without a director of licensing and a director of testing after a pair of resignations in August. And the state treasurer recently terminated former chair Shannon O’Brien after a year-long suspension for making a series of “racially, ethnically, [and] culturally insensitive” remarks during her year heading the commission. She intends to appeal the decision in court.

Julie K. Johnson, the chief of research now on leave, said the interpersonal dysfunction at the agency has slowed its productivity.

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She was recruited six years ago in the commission’s early days to lead the team legally charged with analyzing the social, economic, and health impacts of marijuana legalization statewide . That covers everything from its impact on impaired driving and the size of the illicit market to the ownership demographic breakdown within the industry.

Johnson, who previously conducted research for Johns Hopkins University, Brandeis University, and Boston Children’s Hospital, said her team is a year behind schedule and frequently struggles to access internal data, because of mismanagement at the commission.

“For the health of a thriving cannabis industry, consumers, constituents, and importantly, staff members tasked with ensuring the health of the industry, I personally believe that both staff and taxpayers alike deserve an external, objective audit to find the collective truth(s) and finally right the ship here at the Commission,” she wrote on Friday.

Johnson’s statement alleged she had been repeatedly mistreated by members of the commission’s top brass since 2020.

Johnson said she was contacted by commission leadership Monday about setting up a meeting. She said she feared she would be disciplined or fired over her online statement, and decided to take a two-month leave to try and avoid retaliation from her bosses.

“I felt like such an outsider from the beginning because everybody in the agency is so buddy-buddy,” she told the Globe. “Now I have exhausted all internal options for bringing up these issues.”

In a statement, a commission spokesperson said “the agency remains deeply committed to promoting a positive workplace where employees can thrive and effectively contribute towards its mission and mandate of regulating a safe, equitable, and effective medical and adult-use marijuana industry for the Commonwealth.”

Johnson’s public statement came after CommonWealth Beacon published state investigative reports last week surrounding allegations involving O’Brien, the former chair who was recently terminated. In one report, O’Brien and chief communications officer Cedric Sinclair traded allegations of bullying, harassment, and discrimination. Commissioner Nurys Camargo also alleged that O’Brien had made racially insensitive comments toward her during O’Brien’s tenure.

State treasurer Deborah Goldberg has said she fired O’Brien for racially “inappropriate” comments, and did not provide further details.

Johnson told the Globe her belief that O’Brien was mistreated motivated in part her to go public with her own experiences.

Johnson’s Friday statement did not describe in detail what she had experienced, but internal commission documents reviewed by the Globe show Johnson described suffering from “severe and regular” panic attacks due to her interactions with Camargo and Sinclair.

In 2022, Johnson acquired a medical waiver requesting to be removed from working with Camargo and only have limited interaction with Sinclair. Working with them, Johnson said, was amplifying her existing medical conditions.

In a January 2023 letter to then-executive director Shawn Collins, Johnson said Camargo made “harmful and continued remarks” about the demographics of her research team and implied repeatedly that they could not do their jobs. In another letter to the acting executive director earlier this year, Johnson said, “I was exposed to physical intimidation and potential assault by Cedric Sinclair after experiencing verbal intimidation and displays of physical agitation.”

“The specific and combined behaviors of Nurys Camargo and Cedric Sinclair seemed to not only cause harm and disruption to the work we collectively conduct at the agency but created a hostile work environment(s) for those more intimately involved. For me, these behaviors caused serious harm, affecting my family as well,” Johnson complained to officials.

Johnson told the Globe her complaints were not investigated.

Collins, who left the commission in December 2023, declined to comment on “internal personnel matters.” Camargo also declined to comment.

Sinclair was suspended last December, after which he was accused of poor leadership at the commission by other workers. Three other women said they were pushed out or chose to leave because of harassment by Sinclair between 2019 and 2021, according to a June report from WBUR. An investigation into those allegations did not find any policies were violated, WBUR reported.

In a personal statement, Sinclair said “multiple credible witnesses disputed” allegations that he has harmed women at the agency, and that he has now filed a complaint with the Massachusetts Commission Against Discrimination to address his issues with the commission.

“The agency has conducted comprehensive investigations into several verifiably false claims against me and found that they were not substantiated by the facts,” Sinclair said, adding: “It has become commonplace for some staff to orchestrate unsubstantiated, racist, and retaliatory political hits on their peers for the benefit of Commissioners who previously worked at the agency.”

An investigatory report found that Sinclair’s bullying allegations against O’Brien were also not sustained by the investigation. The probe did find that O’Brien, who is white, had made racially insensitive comments that could be interpreted to mean diverse candidates, including Camargo, were not qualified to be chair.

Diti Kohli can be reached at [email protected] . Follow her @ditikohli_ .