12/08/2020
Image by Louis Reed from Unsplash
Diversity in clinical research is imperative to ensure the safety and effectiveness of drugs and medical devices for all people. Participants in clinical trials should reflect the consumers that will be using the medical product once it is approved. This is a concern because the product may react differently in different age groups, races, and ethnicities. The National Institutes of Health (NIH) confronted a lack of diversity in clinical trial participants in 1993 by supporting a policy requiring federally funded clinical research to include women and minorities called the NIH Revitalization Act of 1993. Clinical trials today still lack ethnic diversity, and the question remains as to how stakeholders can build equity into clinical trial design.
In a recent webinar on diversity in clinical trials, Dr. Jonathan Jackson from Harvard Medical School states that most research participants today share 5 characteristics:
White
Male
Live near an urban center on the East or West Coasts of the U.S.
Earn at least twice the level of median income in the U.S.
Have a master’s or doctoral degree
If you are not all five of these characteristics simultaneously, then you are underrepresented in research.
In a related Q & A blog, several ideas are discussed to increase racial diversity in trials and improve equity in research. Ideas discussed are:
Setting up Community Health Centers (CHCs) as research sites so patients do not have to leave their community or healthcare provider (HCP)
Focusing on empowerment, education and engagement instead of rebuilding trust
Involving patients in protocol development and community advisory boards
Allocating funds in research budgets to provide transportation and translators as a standard practice
Standardizing clinical research as part of care to help HCPs encourage research with their patients
Providing incentives and value for clinical providers to promote research
Research proposes that a study participant’s own provider is their most trusted source of health information. HCPs in the community would like to link their patients with research opportunities and it would be easiest if these opportunities were in the communities where the patients live. Perhaps changing where research happens, making minor shifts in how we think about patients, and implementing alternate strategies around funding and standardization of research are areas where we can begin to tackle this problem and build equity into our clinical trial designs.
You may also be interested in our blog on New FDA Guidance! Enhancing the Diversity of Clinical Trial Populations which describes actions a sponsor can take in protocol and trial design to improve enrollment of underrepresented populations.
-The Clinical Pathways Team
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