AER19 Panel I: Diverse Representation in Clinical Trials


Moderator: Barbara E. Bierer, MD ; Faculty Director, Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard; Professor of Medicine, Harvard Medical School
Denise Anne Dillard, PhD; Director of Research, Southcentral Foundation
Tesheia Johnson, MBA, MHS; Deputy Director and Chief Operating Officer, Yale Center for Clinical Investigation; Associate Director of Clinical Research, Yale School of Medicine, Yale University
Paul Underwood, MD FACC; Medical Director, Boston Scientific Corporation

The prescribing and marketing of drug products to subpopulations for whom response and tolerability have not been studied represents a shortcoming in medical science and raises justice-related concerns about access to appropriate treatment. Despite healthcare and ethical mandates, little progress has been made towards ensuring the composition of clinical trials reflects the diversity of the population at large. When historically under-represented groups remain understudied, variability in treatment response and tolerability go undetected. Although scholars caution against inappropriate use of population descriptors, such as race as a variable in clinical research, considerable data support the scientific and social value of inclusiveness in clinical trial enrollment across sex, gender, race, ethnicity, age, and socio-demographic factors to ensure study findings are relevant to all populations who stand to benefit from new interventions. What is the scientific value of diversity and inclusiveness in drug development? How do we understand the mandate for diversity on a global scale? What conceptual, cultural, organizational, and scientific factors impede progress? This session brings together leaders from industry and academia to discuss the importance of diversifying trials, with reference to success stories within indigenous communities and the international context. The panel will propose and discuss actionable and scalable solutions to address impediments at the level of trial development and implementation to promote the goal of diversity in enrollment and to facilitate necessary subgroup analyses in clinical trials.