clinical research annual report

Research Annual Report

From our director.

One of the perks of my job is sharing the Research Annual Report on behalf of the Cincinnati Children’s Research Foundation. It is quite a proud moment, as each edition boasts our health system’s highest achievements in science, research and discovery over the past year.

And, we have much to be proud of, having achieved several firsts. In addition to emerging from the COVID pandemic as one united institution that helped to address a major public health problem, Cincinnati Children’s was named No. 1 in the nation in U.S. News & World Report ’s Best Children’s Hospitals 2023-24 rankings. This remarkable honor recognized our organization’s dedication to “changing the outcome together,” but while it’s a privilege to be No. 1, we remain attuned to the incredible responsibility it brings to always be the best.

Read More from Cincinnati Children's Research Foundation Director, Tina L. Cheng, MD, MPH

By The Numbers

2023 at a glance.

The Cincinnati Children's Research Foundation serves as one of the nation's most significant sources of pediatric scientific discovery and innovation.

Top Scientific Achievements

The science of pediatrics is the science of humanity. That science is not limited to the diseases and conditions that strike during childhood. Our mission also includes seeking to understand the driving factors of adult disease that so often trace their roots to childhood.

The full spectrum of pediatric research not only extends beyond the legal age of adulthood, it reaches far beyond the traditional definitions of medicine to include the many social and environmental determinants of health. These factors,which have been shown through epigenetics to change the very blueprints of our lives, require exploration every bit as rigorous as the technological advances that allow us to study the entire genome of one cell to the next.

That’s the mission we pursue as we seek to change the outcomes for children. Together.

The following stories illustrate how the Cincinnati Children’s Research Foundation supports the work of dedicated faculty who work across the full spectrum of discovery: from basic to preclinical and clinical research to implementing best practices, driving public health improvements, and achieving health care equity and justice.

Chasing the Undiscovered

From secrets of brain development to mysteries of somite segmentation, scientists at Cincinnati Children’s pursue deeper understanding of the human condition.

Building the Platforms of Discovery

From developing advanced organoids to inventing ways to deliver therapy to muscle tissues, Cincinnati Children’s researchers are leaders in creating new tools that can accelerate the chase for cures.

The Art of Moving Discovery from Bench to Bedside

Be it carrying out classic three-phase clinical drug trials or following other closely regulated avenues of human subjects research, investigators at Cincinnati Children’s are leaders in translating lab breakthroughs into real treatments that improve outcomes.

Accelerating Best Practices

From advancing the use of virtual reality training to preventing cardiac arrest during intensive care, clinician-scientists at Cincinnati Children’s strive to be the best at getting better.

A Quest to Improve Outcomes for All Children

Be it addressing inequities in hospital care, remaining ever-vigilant about disease outbreaks, or applying research expertise in new ways to achieve population scale impact, science at Cincinnati Children’s extends well beyond our walls.

50 Remarkable Discoveries and Accomplishments

A deeper commitment to health justice & eliminating health inequities.

The new Michael Fisher Child Health Equity Center will build partnerships and expand research to address challenges, starting with the region’s 10 most disadvantaged communities.

The primary goals of the center are to build upon and accelerate a track record of community health commitment at Cincinnati Children’s—and to do so in a way that forges a much deeper bond within a network of families, care providers, agencies and community leaders who share the goal of eliminating health inequities and achieving health justice.

The Fisher Center represents the next big leap forward at Cincinnati Children’s to bring many important threads of progress into a full tapestry that can foster a bolder impact on community health and health equity.

Learn More About the Michael Fisher Child Health Equity Center

Innovation Ventures

Cincinnati Children’s Innovation Ventures is a resource dedicated to helping employees navigate the complex journey of getting their ideas and innovations to the commercial market so that they can improve patient care and public health.

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Annual report

Annual report 2023.

In this annual report, we will highlight the sponsored clinical research milestones achieved under CRM’s guided principles of HUMANITY, STABILITY & SUSTAINABILITY. With CRM’s focus in bridging unmet needs in patient care through clinical trials (HUMANITY) and creating the professional clinical trial management ecosystem that consistently delivers trials with speed, quality & reliability (STABILITY), Malaysia is now at a prominent position in the footprint of global trials. Finally, in the trust built with the stakeholders, CRM is committed to create a conducive, sustainable clinical research environment, as a Global Trusted Research Management organisation (SUSTAINABILITY).

Phase 1 Realisation Report (P1RP)

Clinical Research Malaysia is pleased to share the achievements of the Phase 1 Realisation Project (P1RP). The P1RP was initiated by CRM in 2016, with the support of the Ministry of Health, to ensure Malaysia’s readiness for safe and quality conduct of early phase trials, especially First-in-Human trials. With the completion of this project in 2021, Malaysia has the needed framework, trained regulators, equipped study site and experienced study team in place for First-in-Human trial conduct.

Previous Year Annual Report:

1. CRM Annual Report 2022

1. CRM Annual Report 2021

2. CRM Annual Report 2020

3. CRM Annual Report 2019

4. CRM Annual Report 2018

5. CRM Annual Report 2017

6. CRM Annual Report 2016

Annual Report 2022

Submit Annual Reports to the FDA

ANNUAL REPORTS TO CDER

For clinical trials being conducted under an IND, FDA requires an annual report from the Sponsor or Sponsor-Investigator. The annual report is due within 60 days of the anniversary date that the IND went effect (i.e., the date that the FDA permitted the study to begin). Required content is listed in 21 CFR 312.33 .

ANNUAL REPORTS TO CDRH

For clinical trials being conducted under an IDE, FDA requires Sponsors to submit progress reports, at regular intervals, and at least yearly. Reports must be submitted to all reviewing IRBs and in the case of significant risk devices the sponsor must also submit the progress report to FDA ( 21 CFR 812.150 ).

Contact the Office for Research Protections Quality Assurance Program for assistance:  [email protected] .

2023 Annual Report

• 2022 Annual Report
• 2021 Annual Report
• 2020 Annual Report
• 2019 Annual Report
• 2018 Annual Report
• 2017 Annual Report
• 2016 Annual Report

Annual Reports

Department of Medicine

Global & Local Challenges

Disease & chronic conditions, health equity & diversity, staff & resident spotlights, department events, reflect & renew.

Past Reports

2019 Annual Report: Transforming Clinical Trials

No single stakeholder can successfully address the challenges in clinical research. Because of this, the  Clinical Trials Transformation Initiative (CTTI) , a public-private partnership co-founded by Duke University and the FDA in 2007, brings together stakeholders from across the clinical research ecosystem to create new solutions for better, more efficient clinical trials.

With representation from academia, clinical investigators, government and regulatory agencies, industry, institutional review boards, patient advocacy groups, and others, CTTI has created over 20 recommendations and associated resources that address current challenges and opportunities in clinical research. Organizations have implemented these recommendations and resources to improve their clinical trials, and regulatory agencies have cited the work in developing new policies. Led by Executive Director Pamela Tenaerts, MD, MBA, CTTI works to determine strategies to accomplish its mission. The DCRI, which serves as the host of CTTI, and Duke University more broadly play a critical role in this collaboration. The DCRI’s John Alexander, MD, MHS, is CTTI co-chair and sits on the executive committee, which is chaired by Mark McClellan, MD, PhD, director of the Duke-Margolis Center for Health Policy.

Recent CTTI work includes creating a comprehensive set of recommendations and resources to drive the appropriate use of mobile technologies in clinical trials. Additionally, CTTI announced new resources to facilitate the implementation of single institutional review boards (sIRBs) in multicenter trials, building on many years of leading the culture shift around the use of sIRBs. This work is especially important given the 2018 Common Rule, which requires that all U.S. institutions involved in U.S.-based cooperative research use a sIRB by January 20, 2020. And, closing out 2019, CTTI also announced recommendations, resources, and case studies detailing how to leverage real-world data to plan trial eligibility criteria and recruit participants in clinical research. Looking ahead, CTTI will continue this momentum and embark on new areas of work.

This article originally appeared in the DCRI’s 2018-2019 Annual Report. View the annual reports .

PolicyLab Annual Impact Report

Scroll to explore.

Introduction

Our care for children and families drives our evidence-to-action approach.

From the Director

The mission of PolicyLab at Children’s Hospital of Philadelphia (CHOP) is to achieve optimal child health and well-being by informing program and policy changes through interdisciplinary research. PolicyLab is a Center of Emphasis within Children’s Hospital of Philadelphia Research Institute , one of the largest pediatric research institutes in the country.

At PolicyLab, we have a commitment to hiring and engaging in partnerships to create an environment that is reflective of the diverse communities we serve. We aim to provide every team member with opportunities that allow their voices to be heard as this exemplifies our core belief in the power of diverse thinking to influence the policies, protocols, and practices that define our workplace and improve the lives of children and families.

Clinical Research

Graduate Program

The Master of Science in Clinical Research program is designed for early-career health care professionals including physicians, dentists, pharmacists, and nurses. They will explore epidemiology and biostatistics, and learn about decision sciences, applied omics science, and translating innovation into clinical practice.

• Article Information

Data Sharing Statement

• As Ozempic’s Popularity Soars, Here’s What to Know About Semaglutide and Weight Loss JAMA Medical News & Perspectives May 16, 2023 This Medical News article discusses chronic weight management with semaglutide, sold under the brand names Ozempic and Wegovy. Melissa Suran, PhD, MSJ
• Patents and Regulatory Exclusivities on GLP-1 Receptor Agonists JAMA Special Communication August 15, 2023 This Special Communication used data from the US Food and Drug Administration to analyze how manufacturers of brand-name glucagon-like peptide 1 (GLP-1) receptor agonists have used patent and regulatory systems to extend periods of market exclusivity. Rasha Alhiary, PharmD; Aaron S. Kesselheim, MD, JD, MPH; Sarah Gabriele, LLM, MBE; Reed F. Beall, PhD; S. Sean Tu, JD, PhD; William B. Feldman, MD, DPhil, MPH
• What to Know About Wegovy’s Rare but Serious Adverse Effects JAMA Medical News & Perspectives December 12, 2023 This Medical News article discusses Wegovy, Ozempic, and other GLP-1 receptor agonists used for weight management and type 2 diabetes. Kate Ruder, MSJ
• GLP-1 Receptor Agonists and Gastrointestinal Adverse Events—Reply JAMA Comment & Response March 12, 2024 Ramin Rezaeianzadeh, BSc; Mohit Sodhi, MSc; Mahyar Etminan, PharmD, MSc
• GLP-1 Receptor Agonists and Gastrointestinal Adverse Events JAMA Comment & Response March 12, 2024 Karine Suissa, PhD; Sara J. Cromer, MD; Elisabetta Patorno, MD, DrPH
• GLP-1 Receptor Agonist Use and Risk of Postoperative Complications JAMA Research Letter May 21, 2024 This cohort study evaluates the risk of postoperative respiratory complications among patients with diabetes undergoing surgery who had vs those who had not a prescription fill for glucagon-like peptide 1 receptor agonists. Anjali A. Dixit, MD, MPH; Brian T. Bateman, MD, MS; Mary T. Hawn, MD, MPH; Michelle C. Odden, PhD; Eric C. Sun, MD, PhD
• Glucagon-Like Peptide-1 Receptor Agonist Use and Risk of Gallbladder and Biliary Diseases JAMA Internal Medicine Original Investigation May 1, 2022 This systematic review and meta-analysis of 76 randomized clinical trials examines the effects of glucagon-like peptide-1 receptor agonist use on the risk of gallbladder and biliary diseases. Liyun He, MM; Jialu Wang, MM; Fan Ping, MD; Na Yang, MM; Jingyue Huang, MM; Yuxiu Li, MD; Lingling Xu, MD; Wei Li, MD; Huabing Zhang, MD
• Cholecystitis Associated With the Use of Glucagon-Like Peptide-1 Receptor Agonists JAMA Internal Medicine Research Letter October 1, 2022 This case series identifies cases reported in the US Food and Drug Administration Adverse Event Reporting System of acute cholecystitis associated with use of glucagon-like peptide-1 receptor agonists that did not have gallbladder disease warnings in their labeling. Daniel Woronow, MD; Christine Chamberlain, PharmD; Ali Niak, MD; Mark Avigan, MDCM; Monika Houstoun, PharmD, MPH; Cindy Kortepeter, PharmD

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Sodhi M , Rezaeianzadeh R , Kezouh A , Etminan M. Risk of Gastrointestinal Adverse Events Associated With Glucagon-Like Peptide-1 Receptor Agonists for Weight Loss. JAMA. 2023;330(18):1795–1797. doi:10.1001/jama.2023.19574

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© 2024

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Risk of Gastrointestinal Adverse Events Associated With Glucagon-Like Peptide-1 Receptor Agonists for Weight Loss

• 1 Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada
• 2 StatExpert Ltd, Laval, Quebec, Canada
• 3 Department of Ophthalmology and Visual Sciences and Medicine, University of British Columbia, Vancouver, Canada
• Medical News & Perspectives As Ozempic’s Popularity Soars, Here’s What to Know About Semaglutide and Weight Loss Melissa Suran, PhD, MSJ JAMA
• Special Communication Patents and Regulatory Exclusivities on GLP-1 Receptor Agonists Rasha Alhiary, PharmD; Aaron S. Kesselheim, MD, JD, MPH; Sarah Gabriele, LLM, MBE; Reed F. Beall, PhD; S. Sean Tu, JD, PhD; William B. Feldman, MD, DPhil, MPH JAMA
• Medical News & Perspectives What to Know About Wegovy’s Rare but Serious Adverse Effects Kate Ruder, MSJ JAMA
• Comment & Response GLP-1 Receptor Agonists and Gastrointestinal Adverse Events—Reply Ramin Rezaeianzadeh, BSc; Mohit Sodhi, MSc; Mahyar Etminan, PharmD, MSc JAMA
• Comment & Response GLP-1 Receptor Agonists and Gastrointestinal Adverse Events Karine Suissa, PhD; Sara J. Cromer, MD; Elisabetta Patorno, MD, DrPH JAMA
• Research Letter GLP-1 Receptor Agonist Use and Risk of Postoperative Complications Anjali A. Dixit, MD, MPH; Brian T. Bateman, MD, MS; Mary T. Hawn, MD, MPH; Michelle C. Odden, PhD; Eric C. Sun, MD, PhD JAMA
• Original Investigation Glucagon-Like Peptide-1 Receptor Agonist Use and Risk of Gallbladder and Biliary Diseases Liyun He, MM; Jialu Wang, MM; Fan Ping, MD; Na Yang, MM; Jingyue Huang, MM; Yuxiu Li, MD; Lingling Xu, MD; Wei Li, MD; Huabing Zhang, MD JAMA Internal Medicine
• Research Letter Cholecystitis Associated With the Use of Glucagon-Like Peptide-1 Receptor Agonists Daniel Woronow, MD; Christine Chamberlain, PharmD; Ali Niak, MD; Mark Avigan, MDCM; Monika Houstoun, PharmD, MPH; Cindy Kortepeter, PharmD JAMA Internal Medicine

Glucagon-like peptide 1 (GLP-1) agonists are medications approved for treatment of diabetes that recently have also been used off label for weight loss. 1 Studies have found increased risks of gastrointestinal adverse events (biliary disease, 2 pancreatitis, 3 bowel obstruction, 4 and gastroparesis 5 ) in patients with diabetes. 2 - 5 Because such patients have higher baseline risk for gastrointestinal adverse events, risk in patients taking these drugs for other indications may differ. Randomized trials examining efficacy of GLP-1 agonists for weight loss were not designed to capture these events 2 due to small sample sizes and short follow-up. We examined gastrointestinal adverse events associated with GLP-1 agonists used for weight loss in a clinical setting.

We used a random sample of 16 million patients (2006-2020) from the PharMetrics Plus for Academics database (IQVIA), a large health claims database that captures 93% of all outpatient prescriptions and physician diagnoses in the US through the International Classification of Diseases, Ninth Revision (ICD-9) or ICD-10. In our cohort study, we included new users of semaglutide or liraglutide, 2 main GLP-1 agonists, and the active comparator bupropion-naltrexone, a weight loss agent unrelated to GLP-1 agonists. Because semaglutide was marketed for weight loss after the study period (2021), we ensured all GLP-1 agonist and bupropion-naltrexone users had an obesity code in the 90 days prior or up to 30 days after cohort entry, excluding those with a diabetes or antidiabetic drug code.

Patients were observed from first prescription of a study drug to first mutually exclusive incidence (defined as first ICD-9 or ICD-10 code) of biliary disease (including cholecystitis, cholelithiasis, and choledocholithiasis), pancreatitis (including gallstone pancreatitis), bowel obstruction, or gastroparesis (defined as use of a code or a promotility agent). They were followed up to the end of the study period (June 2020) or censored during a switch. Hazard ratios (HRs) from a Cox model were adjusted for age, sex, alcohol use, smoking, hyperlipidemia, abdominal surgery in the previous 30 days, and geographic location, which were identified as common cause variables or risk factors. 6 Two sensitivity analyses were undertaken, one excluding hyperlipidemia (because more semaglutide users had hyperlipidemia) and another including patients without diabetes regardless of having an obesity code. Due to absence of data on body mass index (BMI), the E-value was used to examine how strong unmeasured confounding would need to be to negate observed results, with E-value HRs of at least 2 indicating BMI is unlikely to change study results. Statistical significance was defined as 2-sided 95% CI that did not cross 1. Analyses were performed using SAS version 9.4. Ethics approval was obtained by the University of British Columbia’s clinical research ethics board with a waiver of informed consent.

Our cohort included 4144 liraglutide, 613 semaglutide, and 654 bupropion-naltrexone users. Incidence rates for the 4 outcomes were elevated among GLP-1 agonists compared with bupropion-naltrexone users ( Table 1 ). For example, incidence of biliary disease (per 1000 person-years) was 11.7 for semaglutide, 18.6 for liraglutide, and 12.6 for bupropion-naltrexone and 4.6, 7.9, and 1.0, respectively, for pancreatitis.

Use of GLP-1 agonists compared with bupropion-naltrexone was associated with increased risk of pancreatitis (adjusted HR, 9.09 [95% CI, 1.25-66.00]), bowel obstruction (HR, 4.22 [95% CI, 1.02-17.40]), and gastroparesis (HR, 3.67 [95% CI, 1.15-11.90) but not biliary disease (HR, 1.50 [95% CI, 0.89-2.53]). Exclusion of hyperlipidemia from the analysis did not change the results ( Table 2 ). Inclusion of GLP-1 agonists regardless of history of obesity reduced HRs and narrowed CIs but did not change the significance of the results ( Table 2 ). E-value HRs did not suggest potential confounding by BMI.

This study found that use of GLP-1 agonists for weight loss compared with use of bupropion-naltrexone was associated with increased risk of pancreatitis, gastroparesis, and bowel obstruction but not biliary disease.

Given the wide use of these drugs, these adverse events, although rare, must be considered by patients who are contemplating using the drugs for weight loss because the risk-benefit calculus for this group might differ from that of those who use them for diabetes. Limitations include that although all GLP-1 agonist users had a record for obesity without diabetes, whether GLP-1 agonists were all used for weight loss is uncertain.

Accepted for Publication: September 11, 2023.

Published Online: October 5, 2023. doi:10.1001/jama.2023.19574

Correction: This article was corrected on December 21, 2023, to update the full name of the database used.

Corresponding Author: Mahyar Etminan, PharmD, MSc, Faculty of Medicine, Departments of Ophthalmology and Visual Sciences and Medicine, The Eye Care Center, University of British Columbia, 2550 Willow St, Room 323, Vancouver, BC V5Z 3N9, Canada ( [email protected] ).

Author Contributions: Dr Etminan had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Sodhi, Rezaeianzadeh, Etminan.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Sodhi, Rezaeianzadeh, Etminan.

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

Statistical analysis: Kezouh.

Obtained funding: Etminan.

Administrative, technical, or material support: Sodhi.

Supervision: Etminan.

Conflict of Interest Disclosures: None reported.

Funding/Support: This study was funded by internal research funds from the Department of Ophthalmology and Visual Sciences, University of British Columbia.

Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Data Sharing Statement: See Supplement .

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• Conferences

Great Lakes Breast Cancer Research Symposium

October 27 th - 29 th , 2024, description.

The sixth annual Great Lakes Breast Cancer Research Symposium will highlight ongoing basic, translational, clinical, and population research, focusing on risk factors, outcomes, survivorship; tumor cell biology; cancer biomarkers; immuno-oncology and molecularly-targeted diagnostics and therapeutics. The mission of the symposium is to bring together a diverse audience to create a collaborative research environment with a long-term goal of developing cross-institutional collaborations, clinical trials, and treatments for breast cancer.

NOTE: Session 1 - Risk Factors, Outcomes, and Survivorship - will convene at the Blackwell Inn, 2110 Tuttle Park Place, on The Ohio State University campus.

For pricing information, see pricing tab below.

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Start: 10/27/2024 1:00 PM End: 10/29/2024 2:00 PM

At the conclusion of this continuing medical education activity participants should be able to:

1. Promote networking amongst clinical providers and members of the pharmaceutical and biotech industries which will lead to new research collaborators. 2. Aid researchers in identifying patient populations that will benefit from the further development of cancer therapeutics or other inventions. 3. Integrate recent data and employ the finding as they seek to optimize different therapies available for breast cancer patients. 4. Describe best practices for symptom management related to breast cancer and its treatment side effects.

Vitria On the Square 14 E. 15th Avenue Columbus, OH 43201

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The Ohio State University is accredited by the Accreditation Council for Continuing Medical Education (ACCME®) to provide continuing medical education for physicians.

AMA Credit Designation Statement

The Ohio State University designates this live activity for a maximum of 13.25 AMA PRA Category 1 Credit (s) ™ . Physicians should only claim credit commensurate with the extent of their participation in the activity.

Need help with this conference?

Please contact the conference coordinator listed below:

Sarah Schmidt Department: Comprehensive Cancer Centre Phone: (614) 293-5521 Email: [email protected]

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Report of the Nominations Committee

The 2024 Nominations Committee has recommended the following slate of candidates for the 2025 ACCP election. The election will be held in spring 2025, and successful candidates will assume office at the 2025 ACCP Annual Meeting in Minneapolis, Minnesota.

President-Elect:

Sarah McBane, Pharm.D., FCCP, BCPS; Irvine, CA

Toby Trujillo, Pharm.D., FCCP, FAHA, BCPS; Superior, CO

Robert J. DiDomenico Jr, Pharm.D., FCCP; Chicago, IL

Paul O. Gubbins, Pharm.D., FCCP; Springfield, MO

Kalen B. Manasco, Pharm.D., FCCP, FPPA, BCPPS, BCPS; Newberry, FL

Pamela L. Stamm, Pharm.D., FCCP, BCACP, BCPS, CDCES; Cataula, GA

Foundation Trustee:

Kevin W. Garey, Pharm.D., FCCP, BCIDP; Houston, TX

Douglas L. Jennings, Pharm.D., FCCP; New York, NY

Darren L. Knoell, Pharm.D., FCCP; Omaha, NE

Christina M. Madison, Pharm.D., FCCP, AAHIVP; Las Vegas, NV

Additional nominations may be made in writing to the College’s secretary, Kayla Stover, at ACCP, 13000 West 87th Street Parkway, Suite 100, Lenexa, KS 66215. Nominations must clearly state the candidate’s qualifications, be signed by at least 82 Full Members (1% of members eligible to vote), and be submitted no later than September 12, 2024.

Respectfully submitted by Ty Kiser (chair), Jessica Cottreau (vice chair), Keith Olsen (secretary), Kelly Cochran, M. Lynn Crismon, Mary Lee, and Jennifer Trofe-Clark

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Associate Board Awards $150,000 in Research and Clinical Grants to Lurie Cancer Center Scientists

On August 8th, the Associate Board of Lurie Cancer Center held its third-annual summer cocktail reception, where it awarded $150,000 in grants to two scientists conducting novel cancer research at Robert H. Lurie Comprehensive Cancer Center of Northwestern University .

Adam Lin, MD, PhD, an assistant professor of Medicine in the Division of Hematology and Oncology, won the $100,000 Innovative Research Award to investigate the use of nanotechnology and laser ablation techniques to treat cancerous tumors. Shira Dinner, MD, associate professor of Medicine in the Division of Hematology and Oncology, was the inaugural winner of the Innovative Clinical Trial Award. She was awarded $50,000 for her Phase 1 trial of tomivosertib, a drug that could treat relapsed/refractory acute myeloid leukemia.

The awards cap another successful year for the Associate Board of Lurie Cancer Center, which formed in 2021 to give young professionals a platform for advancing cancer care through fundraising and advocacy. The annual Innovative Research Award is intended to boost high-risk, high-reward oncology research at Northwestern, while the new Innovative Clinical Trial Award provides funding for novel and patient-centric supplements to existing clinical trials.

“We've expanded this year to not only to support innovative research, but also clinical trials. This is really exciting because we're supporting both treatment and the patient care aspect,” board co-chair Louise Arnott Cardillo said in opening remarks.

Past awardees include Marcelo Bonini, PhD, a professor of Medicine in the Division of Hematology and Oncology, who investigates how changes in the electrochemical balance of the nucleus alter gene expression patterns and affect cancer growth. Dr. Bonini leveraged his 2022 Innovative Research Award to conduct early-stage experiments that have since led to a new patent for a novel anti-metastatic medication that his laboratory is developing for breast, lung, and pancreatic cancer. This work has also led directly to $5 million in federal grants, part of which will be used to fund translation of his laboratory findings into clinical trials to assess safety and efficacy of his newly-patented medication.

In 2023, the Associate Board of Lurie Cancer Center awarded a $150,000 research grant to  Kehinde U.A. Adekola, MD, MS , associate professor of Medicine in the Division of Hematology and Oncology. Dr. Adekola's research aims to improve outcomes and eliminate health disparities in patients with monoclonal gammopathy of undetermined significance and multiple myeloma.

The Associate Board continues to support high-risk, high-reward projects from researchers and clinical scientists, and is integral in furthering the mission and goals of the Lurie Cancer Center.

Watch A Thank You to the Associate Board of Lurie Cancer Center

For more information about supporting the Associate Board of Lurie Cancer Center, please contact Nicole Langert at  [email protected]  or 312-503-1656.

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August 16, 2024

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New guidelines on how to report clinical sequencing data help doctors make decisions about cancer treatment

by Erika Rindsjö, Karolinska Institutet

Personalized medicine is transforming cancer treatment by tailoring therapies to the genomic profile of each tumor. Next-generation sequencing (NGS) is key to this approach, but its complexity and inconsistent reporting have been hurdles. A recent paper in Annals of Oncology introduces new guidelines to standardize NGS reports, aiding clinicians in making informed decisions and improving patient outcomes.

The optimal management of cancer patients is increasingly reliant on individualized treatments guided by the genomic profiling of tumors. At the forefront of this revolution is next-generation sequencing (NGS), a technology that enables the analysis of hundreds or even thousands of genes at a relatively low cost. These insights are pivotal in selecting the most appropriate therapies based on the specific molecular characteristics of each patient's tumor, forming a cornerstone of modern precision oncology.

Standardized approach supports clinical decision-making

However, the interpretation of NGS assay results can be challenging for physicians. The lack of a standardized approach to preparing NGS clinical reports may limit the application and potential benefits of this technology. To address this issue, the Precision Medicine Working Group (PMWG) of the European Society of Medical Oncology (ESMO) has developed recommendations for presenting NGS results to support clinical decision-making in patients with solid cancers.

These guidelines are based on a consensus among international experts in genomics-based oncology, including perspectives from a patient advocate.

"The complexity of NGS data used in cancer care is rapidly increasing, and effective communication of the information to the medical teams is crucial. Clear and standardized NGS reports are key to minimize uncertainties, reduce inequalities between centers with varying levels of experience, and optimize patient benefits from available treatment options," says David Tamborero, a senior researcher at SciLifeLab and Department of Oncology-Pathology and one of the senior authors of the paper.

The paper provides detailed guidance on how to structure NGS reports and the content to include in different sections. The recommendations are organized into priority levels, making them adaptable to various laboratory and clinical settings.

"It was important to achieve a broad consensus on how NGS findings should be reported to clinicians," Tamborero adds. We believe these recommendations will be valuable for all laboratories supporting clinical practice and clinical research , helping to harmonize efforts across centers and ensuring the best possible decisions for patients.

This initiative marks a significant step forward in the field of precision oncology, promising to enhance the clarity and utility of NGS clinical reports and ultimately improve patient outcomes .

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