Clinical Trial Diversity: Who is Accountable?

Clinical Trial Diversity: Who is Accountable

Introduction:

On April 27th, 2022, Dr. Lauren D. Nephew, MD, MA, MSCE gave TREATs talk "Clinical Trial Diversity: Who is Accountable?" In the talk, she examined why diversity is important in clinical trials, how pervasive the issue is, and potential solutions. She touches on the earned mistrust minority populations have towards the medical community as well as towards clinical research and barriers between both patients and providers in care settings. She points to accountability as a solution in promoting diversity in clinical trials, as well as individual, institutional, and policy changes that will aid in promoting diversity in clinical trials.

References:

Fisher, Jill A., and Corey A. Kalbaugh. “Challenging Assumptions about Minority Participation in US Clinical Research.”American Journal of Public Health, vol. 101, no. 12, 2011, pp. 2217–2222

Guidance Document - MRCT Center, www.mrctcenter.org/diversity-in-clinical-research/wp-content/uploads/sites/8/2021/09/MRCT-Center-Diversity-Guidance-Document-Version-1.2.pdf.

Katz, Ralph V., et al. “The Tuskegee Legacy Project: Willingness of Minorities to Participate in Biomedical Research.”Journal of Health Care for the Poor and Underserved, vol. 17, no. 4, 2006, pp. 698–715.

“Meeting the Challenge of Diversity and Inclusion in Clinical Trials.”Trialfacts, 26 Aug. 2022.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978.

Nephew, Lauren D., and Marina Serper. “Racial, Gender, and Socioeconomic Disparities in Liver Transplantation.”Liver Transplantation, vol. 27, no. 6, 2021, pp. 900–912.

Sheikh, Saira Z., et al. “The State of Lupus Clinical Trials: Minority Participation Needed.”Journal of Clinical Medicine, vol. 8, no. 8, 2019, p. 1245.

Wendler, David, et al. “Are Racial and Ethnic Minorities Less Willing to Participate in Health Research?”PLoS Medicine, vol. 3, no. 2, 2005.

Younossi, Alexandria, et al. “Enhancing Clinical Trial Diversity.” Deloitte Insights, Deloitte, www2.deloitte.com/us/en/insights/industry/life-sciences/lack-of-diversity-clinical-trials.html.

Clinical Trial Diversity: Who is Accountable?