Michelle D Kelsey1, Bray Patrick-Lake2, Raolat Abdulai3, Uli C Broedl4, Adam Brown5, Elizabeth Cohn6, Lesley H Curtis7, Chris Komelasky8, Michael Mbagwu9, George A Mensah10, Robert J Mentz1, Amesika Nyaku11, Stephanie O Omokaro12, Judy Sewards13, Kendal Whitlock4, Xinzhi Zhang14, Gerald S Bloomfield15. 1. Division of Cardiology, Department of Medicine, Duke University, Durham, NC, USA; Duke Clinical Research Institute, Durham, NC, USA. 2. Evidation Health, Inc., San Mateo, CA, USA. 3. Sanofi, Cambridge, MA, USA. 4. Boehringer Ingelheim GmbH & Co KG, Germany. 5. ClinArk, Dayton, OH, USA. 6. Hunter College, City University of New York, NY, USA. 7. Duke Clinical Research Institute, Durham, NC, USA; Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, USA. 8. SiteBridge, Chapel Hill, NC, USA. 9. Verana Health, San Francisco, CA, USA. 10. National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA. 11. Division of Infectious Diseases, Department of Medicine, Rutgers-New Jersey Medical School, Newark, NJ, USA. 12. United States Food and Drug Administration, MD, USA. 13. Pfizer Inc, New York, NY, USA. 14. National Institute on Minority Health and Health Disparities, National Institutes of Health, Bethesda, MD, USA. 15. Division of Cardiology, Department of Medicine, Duke University, Durham, NC, USA; Duke Clinical Research Institute, Durham, NC, USA. Electronic address: gerald.bloomfield@duke.edu.
Abstract
BACKGROUND: Improving diversity in clinical trials is essential in order to produce generalizable results. Although the importance of representation has become increasingly recognized, identifying strategies to approach this work remains elusive. This article reviews the proceedings of a multi-stakeholder conference about the current state of diversity in clinical trials and outlines actionable steps for improvement. METHODS: Conference attendees included representatives from the United States Food and Drug Administration (FDA), National Institutes of Health (NIH), practicing clinical investigators, pharmaceutical and device companies, community-based organizations, data analytics companies, and patient advocacy groups. At this virtual event, attendees were asked to consider key questions around best practices for engagement of underrepresented populations. RESULTS: Community engagement is an integral part of recruitment and retention of underrepresented groups. Decentralization of sites and use of digital tools can enhance the accessibility of clinical research. Finally, improving representation among investigators and clinical research staff may translate to diverse clinical trial participants. CONCLUSION: Improving diversity in clinical trials is an ethical and scientific imperative, which requires a multifaceted approach.
BACKGROUND: Improving diversity in clinical trials is essential in order to produce generalizable results. Although the importance of representation has become increasingly recognized, identifying strategies to approach this work remains elusive. This article reviews the proceedings of a multi-stakeholder conference about the current state of diversity in clinical trials and outlines actionable steps for improvement. METHODS: Conference attendees included representatives from the United States Food and Drug Administration (FDA), National Institutes of Health (NIH), practicing clinical investigators, pharmaceutical and device companies, community-based organizations, data analytics companies, and patient advocacy groups. At this virtual event, attendees were asked to consider key questions around best practices for engagement of underrepresented populations. RESULTS: Community engagement is an integral part of recruitment and retention of underrepresented groups. Decentralization of sites and use of digital tools can enhance the accessibility of clinical research. Finally, improving representation among investigators and clinical research staff may translate to diverse clinical trial participants. CONCLUSION: Improving diversity in clinical trials is an ethical and scientific imperative, which requires a multifaceted approach.
Authors: Muhammad Rizwan Sardar; Marwan Badri; Catherine T Prince; Jonathan Seltzer; Peter R Kowey Journal: JAMA Intern Med Date: 2014-11 Impact factor: 21.873
Authors: Matthew D Galsky; Kristian D Stensland; Russell B McBride; Asma Latif; Erin Moshier; William K Oh; Juan Wisnivesky Journal: JAMA Intern Med Date: 2015-02 Impact factor: 21.873