TY - JOUR
T1 - Inclusion and diversity in clinical trials
T2 - Actionable steps to drive lasting change
AU - Kelsey, Michelle D.
AU - Patrick-Lake, Bray
AU - Abdulai, Raolat
AU - Broedl, Uli C.
AU - Brown, Adam
AU - Cohn, Elizabeth
AU - Curtis, Lesley H.
AU - Komelasky, Chris
AU - Mbagwu, Michael
AU - Mensah, George A.
AU - Mentz, Robert J.
AU - Nyaku, Amesika
AU - Omokaro, Stephanie O.
AU - Sewards, Judy
AU - Whitlock, Kendal
AU - Zhang, Xinzhi
AU - Bloomfield, Gerald S.
N1 - Funding Information:
MDK is supported by an NIH T32 training grant ( 5T32HL069749-18 ). BPL reports employment by Evidation Health and consulting fees from Bayer Pharmaceuticals. RA reports employment by and might hold stock or stock options in Sanofi. UB reports employment by Boehringer Ingelheim. AB reports leadership or fiduciary role in Sickle Cell Thalassemia Patients Network, The Conscious Connect and the Wittenberg Institute for Public Humanities and Sciences. CK reports employment by and might hold stock or stock options in SiteBridge Research, Inc. RM reports grants and personal fees from Amgen, grants and personal fees from AZ, grants and personal fees from Bayer, grants and personal fees from Merck, personal fees from BI, grants and personal fees from Novartis, personal fees from Abbott, grants from American Regent, grants and personal fees from Medtronic, grants and personal fees from Zoll, personal fees from Boston Scientific, grants and personal fees from Cytokinetics, personal fees from Respicardia, personal fees from Roche, personal fees from Vifor, personal fees from Sanofi, personal fees from Windtree, outside the submitted work; and Received research support and honoraria from Abbott, American Regent, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim/Eli Lilly, Boston Scientific, Cytokinetics, Fast BioMedical, Gilead, Innolife, Medtronic, Merck, Novartis, Relypsa, Respicardia, Roche, Sanofi, Vifor, Windtree Therapeutics, and Zoll. JS reports employment by Pfizer, Inc. GB is supported by R01-MD013493.
Funding Information:
MDK is supported by an NIH T32 training grant (5T32HL069749-18). BPL reports employment by Evidation Health and consulting fees from Bayer Pharmaceuticals. RA reports employment by and might hold stock or stock options in Sanofi. UB reports employment by Boehringer Ingelheim. AB reports leadership or fiduciary role in Sickle Cell Thalassemia Patients Network, The Conscious Connect and the Wittenberg Institute for Public Humanities and Sciences. CK reports employment by and might hold stock or stock options in SiteBridge Research, Inc. RM reports grants and personal fees from Amgen, grants and personal fees from AZ, grants and personal fees from Bayer, grants and personal fees from Merck, personal fees from BI, grants and personal fees from Novartis, personal fees from Abbott, grants from American Regent, grants and personal fees from Medtronic, grants and personal fees from Zoll, personal fees from Boston Scientific, grants and personal fees from Cytokinetics, personal fees from Respicardia, personal fees from Roche, personal fees from Vifor, personal fees from Sanofi, personal fees from Windtree, outside the submitted work; and Received research support and honoraria from Abbott, American Regent, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim/Eli Lilly, Boston Scientific, Cytokinetics, Fast BioMedical, Gilead, Innolife, Medtronic, Merck, Novartis, Relypsa, Respicardia, Roche, Sanofi, Vifor, Windtree Therapeutics, and Zoll. JS reports employment by Pfizer, Inc. GB is supported by R01-MD013493.
Publisher Copyright:
© 2022 Elsevier Inc.
PY - 2022/5
Y1 - 2022/5
N2 - 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.
AB - 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.
KW - Clinical trials
KW - Diversity
KW - Inclusion
KW - Underrepresented populations
UR - http://www.scopus.com/inward/record.url?scp=85127859016&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85127859016&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2022.106740
DO - 10.1016/j.cct.2022.106740
M3 - Article
C2 - 35364292
AN - SCOPUS:85127859016
SN - 1551-7144
VL - 116
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 106740
ER -