ACRP Journal Article Focuses on Clinical Research in Transgender and Gender Diverse Populations

Kirti Salunkhe, MD, WCG IRB Medical Chair

Just in time to help recognize Pride Month, ACRP’s Clinical Researcher journal is pleased to share the first details from the lead peer-reviewed article on “Improving Cardiovascular Research for Transgender and Gender Diverse Populations” from a trio of WCG IRB expert contributors to the new issue going online today (June 13). The article bolsters the issue’s “Let’s Get Personal: Scaling Clinical Research Down to You and Me” theme as it joins several other contributed pieces focused on patient centricity and personalized or precision medicine topics. 

In their introduction to the article, Kirti Salunkhe, MD, WCG IRB Medical Chair; Tara Coffin, PhD, MEd, CIP, Regulatory Chair; and Sharad Adekar, MD, PhD, CIP, Lead Medical Chair, write: “Transgender and gender diverse (TGGD) individuals face an increased risk of cardiovascular disease (CVD). There is an unmet need to identify the root causes of CVD health disparities in this population. More research and evidence-based strategies are needed.” 

The authors note that additional factors to be addressed include possible bias and discrimination in healthcare settings, paucity of representation of TGGD competent care providers, and insufficient resources to encourage and accommodate TGGD individuals wanting to participate in clinical research. “Regulatory authorities, notably the U.S. Food and Drug Administration (FDA), have critical roles to play, as do institutional review boards (IRBs), sponsors, investigators, and patient advocates,” they add. 

Recommendations include adopting community-based research methods; employing scientifically and ethically sound study design; revising participant-facing recruitment and research materials to utilize gender-inclusive language; providing TGGD continuing medical education for staff; and engaging patient advocates familiar with issues faced by TGGD individuals. 

“These measures should help to increase TGGD representation in CVD clinical studies, leading to improved treatment options and health outcomes,” the authors write. 

Other articles in the June issue of Clinical Researcher will include: 

“Disruptive Technologies Redefining the Path of Clinical Trials,” by Deepika Khedekar, MPharm, Centralized Clinical Lead with IQVIA Inc. in India. 

“How an Innovative Statistical Methodology Enables More Patient-Centric Design and Analysis of Clinical Trials,” by Samuel Salvaggio, PhD, Senior Trial Design Lead; Emilie Barré, MSc, Senior Trial Design Lead; Sébastien Coppe, PhD, CEO; and Marc Buyse, ScD, Founder, all with One2Treat. 

“The Illness and the Cure: Technology is Indispensable in Clinical Research, But its Proliferation is Also Causing Friction,” by Elisa Cascade, MBA, Chief Product Officer with Advarra. 

“The Future is Now: Clinical Trials Must Keep Up in the Age of Precision Medicine,” by Rohit Nambisan, MS, MA, CEO and Co-Founder of Lokavant. 

“New Big Data Strategies Will Drive Improvements to Personalized Medicine,” by Stephan Ohnmacht, PhD, Vice President and Head of European R&D Business Consulting for Veeva. 

“Does Risk-Based Quality Management (RBQM) Actually Improve Quality?” by Steve Young, MA, Chief Scientific Officer at CluePoints. 

“The Evolution of Access: A Pathway to Multiple Markets,” by Piety Rocha, Director, Head of Regulatory Affairs & Country VDC Head at PharmaLex, Australia. 

“Establishing Early Efficacy in Depression Clinical Trials,” by Bradley D. Vince, DO, CEO and Chief Medical Officer, and Sheldon H. Preskorn, MD, Senior Vice President, Neuroscience, both with Dr. Vince Clinical Research. 

“Clinical Development of Preventive Antimicrobials,” by Brian Finrow, JD, Founder and CEO of Lumen. 

Edited by Gary Cramer