From both an ethical and scientific perspective, clinical research participation should benefit and represent all individuals. However, for the 48 novel drugs approved in the United States in 2019, it is clear that Black patients were not adequately represented, whereas white participants were overrepresented.1,2

BLACK PARTICIPANTS

IN TRIALS%9VSIN GENERALPOPULATION%12.2IN TRIALS%72VSIN GENERALPOPULATION%60.1

WHITE PARTICIPANTS

IN TRIALS%9VSIN GENERALPOPULATION%12.2IN TRIALS%72VSIN GENERALPOPULATION%60.1

There are also differences by indication, for example, in oncology clinical trials, where Black and Latinx trial participants have been consistently underrepresented based on cancer incidence and mortality in the United States.3

Science and society do recognize the importance of diverse representation in clinical trials, with inclusive health being a keystone to a just, equitable society. In addition, a study population lacking diversity weakens the ability of investigators to adequately understand the safety, efficacy, effectiveness and value of the potential new medication in the general population. The issues that persistently impact study populations are complex, involving a range of inequities in both opportunity and access.

Today, the pharmaceutical industry is gaining a much better grasp of the social determinants of health and health outcomes. Candid discussions between academia, industry, patients, advocacy organizations, physicians and communities provide insight into ways to effectively improve diversity in clinical research.

In order to make this a reality, we must truly commit to collaboratively engaging with patients from a diversity of races, ethnicities and cultures. Only then can we understand the barriers they experience and effectively mitigate them. Diversity and inclusion are possible for clinical trials—but our success depends on our continued, collective focus.

This Parexel report is a topline summary of an extensive, global, quantitative survey, focus group sessions, interviews and Patient Advisory Council meetings that called on patients, members of the public and physicians to provide their perspectives on clinical-trial diversity. Research was a collaborative effort produced with the aim of understanding the critical barriers to research access and obtaining guidance on how to successfully overcome them. To produce this report, the following methods were leveraged:

Video and audio one-on-one interviews Research Method Physician focus groups Parexel Patient Advisory Council Quantitative survey 40 Black, Latinx and Asian members of the public (13.5 hours) Participation 13 Black and Latinx physicians across 2 focus groups (8 hours) 7 Black, Latinx and Asian participants (4 hours) 1,945 respondents across a broad range of racial and ethnic groups UK and USA Countries USA and Canada USA, Italy, Australia and UK USA, Canada, UK, Australia, France, Hungary, Italy, Mexico, Poland and Spain

KEY TAKEAWAY

This report is the result of a series of studies conducted with patients, physicians, prospective clinical-trial participants, active and former clinical-trial participants. The findings of this research identify key barriers to clinical-trial inclusivity while also offering specific actions industry can take to address inequities in healthcare and clinical study access.

  1. Woodcock J, Anagnostiadis E, Lolic M. Center for Drug Evaluation and Research, U.S. Food & Drug Administration. (2020). 2019 Drug Trials Snapshots Summary Report.
  2. Population Distribution by Race/Ethnicity (2019). https://www.kff.org/other/state-indicator/distribution-by-raceethnicity/. Accessed January 8, 2021.
  3. Loree JM, Anand S, Dasari A, et al. Disparity of race reporting and representation in clinical trials leading to cancer drug approvals from 2008 to 2018. JAMA Oncol. 2019;5(10):e191870.

Discussions on Diversity Report

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Executive Summary

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