{"id":613243,"date":"2024-06-13T07:00:44","date_gmt":"2024-06-13T11:00:44","guid":{"rendered":"https:\/\/platohealth.ai\/acrp-journal-article-focuses-on-clinical-research-in-transgender-and-gender-diverse-populations-acrp\/"},"modified":"2024-06-13T09:25:37","modified_gmt":"2024-06-13T13:25:37","slug":"acrp-journal-article-focuses-on-clinical-research-in-transgender-and-gender-diverse-populations-acrp","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/acrp-journal-article-focuses-on-clinical-research-in-transgender-and-gender-diverse-populations-acrp\/","title":{"rendered":"ACRP Journal Article Focuses on Clinical Research in Transgender and Gender Diverse Populations – ACRP","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
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Just in time to help recognize <\/span>Pride Month<\/span><\/a>, ACRP\u2019s <\/span>Clinical Researcher<\/span><\/i><\/a> journal is pleased to share the first details from the lead peer-reviewed article on \u201cImproving Cardiovascular Research for Transgender and Gender Diverse Populations\u201d from a trio of WCG IRB expert contributors to the new issue going online today (June 13). The article bolsters the issue\u2019s \u201cLet\u2019s Get Personal: Scaling Clinical Research Down to You and Me\u201d theme as it joins several other contributed pieces focused on patient centricity and personalized or precision medicine topics.<\/span> <\/span><\/p>\n

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: \u201cTransgender 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.\u201d<\/span> <\/span><\/p>\n

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. \u201cRegulatory 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,\u201d they add.<\/span> <\/span><\/p>\n

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.<\/span> <\/span><\/p>\n

\u201cThese measures should help to increase TGGD representation in CVD clinical studies, leading to improved treatment options and health outcomes,\u201d the authors write.<\/span> <\/span><\/p>\n

Other articles in the June issue of <\/span>Clinical Researcher<\/span><\/i> will include:<\/span> <\/span><\/p>\n

\u201cDisruptive Technologies Redefining the Path of Clinical Trials,\u201d by Deepika Khedekar, MPharm, Centralized Clinical Lead with IQVIA Inc. in India.<\/span> <\/span><\/p>\n

\u201cHow an Innovative Statistical Methodology Enables More Patient-Centric Design and Analysis of Clinical Trials,\u201d by <\/span>Samuel Salvaggio, PhD, Senior Trial Design Lead; Emilie Barr\u00e9, MSc, Senior Trial Design Lead; S\u00e9bastien Coppe, PhD, CEO; and Marc Buyse, ScD, Founder, all with One2Treat.<\/span> <\/span><\/p>\n

\u201cThe Illness and the Cure: Technology is Indispensable in Clinical Research, But its Proliferation is Also Causing Friction,\u201d by Elisa Cascade, MBA, Chief Product Officer with Advarra.<\/span> <\/span><\/p>\n

\u201cThe Future is Now: Clinical Trials Must Keep Up in the Age of Precision Medicine,\u201d by Rohit Nambisan, MS, MA, CEO and Co-Founder of Lokavant.<\/span> <\/span><\/p>\n

\u201cNew Big Data Strategies Will Drive Improvements to Personalized Medicine,\u201d by Stephan Ohnmacht, PhD, Vice President and Head of European R&D Business Consulting for Veeva.<\/span> <\/span><\/p>\n

\u201cDoes Risk-Based Quality Management (RBQM) Actually Improve Quality?\u201d by Steve Young, MA, Chief Scientific Officer at CluePoints.<\/span> <\/span><\/p>\n

\u201cThe Evolution of Access: A Pathway to Multiple Markets,\u201d by Piety Rocha, Director, Head of Regulatory Affairs & Country VDC Head at PharmaLex, Australia.<\/span> <\/span><\/p>\n

\u201cEstablishing Early Efficacy in Depression Clinical Trials,\u201d 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.<\/span> <\/span><\/p>\n

\u201cClinical Development of Preventive Antimicrobials,\u201d by Brian Finrow, JD, Founder and CEO of Lumen.<\/span> <\/span><\/p>\n

Edited by Gary Cramer<\/span><\/i> <\/span><\/p>\n