Diana Foster, Ph.D.
CEO, Total Diversity Clinical Trials Management
One of the most important new areas of emphasis in the clinical trials industry today is the dramatic increase in interest and focus on inclusion of diverse populations in clinical studies. The topic has been in the research domain for decades but never has the emphasis and impetus been greater to move beyond the conversation and highlight the need to operationalize and execute strategy to move the needle in this important area.
Not unlike the advent of organized patient recruitment two decades ago, the diversity “movement”, is almost frenzied as to the attention on the problem and desire to take on an action oriented approach to mitigate the lack of inclusion across therapeutic indications. With no mandates from the FDA or Pharma, only guidance and the recent Depict Act to guide industry, the conversation can be murky and the lack of specific direction contributes to the need to clarify how action can be taken to educate and inform Investigators and research personnel on how to join the movement.
According to the Department of Health and Human Services Healthy people 2020, The focus for racial disparity reduction is on six key areas shown to affect racial and ethnic groups differently at all life stages. They are infant mortality, diabetes, cardiovascular disease, cancer screening and management, HIV/AIDS and child & adult immunizations. (1) The following table depicts the lack of representation of these groups in clinical trials.
|2020 US Census (2)||50.8%||76.3%||14.4%||5.9%||18.5%||16.5%|
|2020 Clinical Trial enrollment Average (3)||56%||75%||8%||6%||11%||30%||54%|
As an example, heart disease was the number one killer of both men and women in the US in 2020 attributing to nearly 690,000 deaths. While heart disease is sometimes thought of as a man’s disease, almost as many women as men die from it each year in the US. Despite the disease affecting men and women almost equally, this is not the case between African Americans and Caucasians. Large racial disparities exist in heart disease risk factors. For example, African Americans have a higher prevalence of cardiovascular risk factors such as diabetes and hypertension. These risk factors lead to African Americans suffering strokes at a staggering rate, as much as 35 percent higher than Caucasians, and the death rate among those suffering strokes is twice as high.
It has been challenging to study the clinical and treatment differences that exist when African Americans make up 12.4 % of the US population yet represent a mere 8% of clinical trial participants. More research needs to be done on this and other populations to determine biological and genetic factors versus social determinants.
In short clinical trials often fail to represent the demographic diversity of the populations that would benefit from the drugs and medical devices under development. A starting point to consider are the best policies to ensure that biomedical research is robust and equitable.
U.S. Congress has recently posed several important questions for consideration.
- How can we best ensure sponsors are held accountable for enrolling participants that reflect the diversity of the intended patient population without inadvertently slowing research?
- How should diversity enrollment targets be determined? Should the targets be based on disease prevalence in the U.S.? How should international clinical trial data be considered?
- How can we make post-marketing requirements more effective?
- How should we structure grant programs within the Department of Health and Human Services to (1) enhance community engagement and outreach to underserved communities and (2) increase the capacity of Community Health Centers to participate in clinical trials and research?
The tipping point on this issue will most certainly be centered around the research site and the understanding of what type of support will be available and how support will be facilitated. Undoubtedly, with more decentralized trial and virtual activity technology will play a major role in reaching underserved populations. Benchmarking site best practices or lack thereof, and underlying assessment of where the education based needs of sites lie will be paramount. Evidence based data not assumptions will guide us. The diversity site assessment tool (DSAT), provides a reliable and valid gold standard for this benchmarking. Also, a new publication in Applied Clinical Trials in July of this year documents findings and analysis of 234 site responses to the DSAT. As more research is conducted, we will more swiftly have answers to moving the needle specific to engaging research sites in diverse enrollment tactics and strategy.
- DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention 01-0304 (10/01) National Center for Health Statistics
Healthy People 2020
- United States Census Bureau 2020 Census
- 2020 FDA Drug Trials Snapshot Summary Report FDA Feb. 2021
(Percent Participation in Clinical Trials by Subpopulation* for New Molecular Entities and Therapeutic Biologics Approved in 2020)
- Foster D. A Pilot Study to Examine the Validity and Reliability of a Site Assessment Checklist for Evaluation of Best Practices of Recruitment of Diverse Patient Populations for Clinical Trials. Insite: The Global Journal for Clinical Research Sites Summer 2020: Page 10-19. Available at: https://cloud.3dissue.com/180561/181052/211361/InSiteSummer2020/index.html
- Foster D. Identify Opportunities to Improve Diversity Recruitment. Applied Clinical Trials. June 23, 2021. Available at https://www.appliedclinicaltrialsonline.com/view/identify-opportunities- to-improve-diversity-recruitment