Diversity in Clinical Trial Volunteers is need to Ensure Standard Efficacy in Drugs

Jul 10, 2020 by CenTrial



In order to get the most accurate data from a clinical trial, researchers need participants of different ages, sexes, and ethnic backgrounds. Why is this important? People from different ethnic groups react about 20% differently to newly approved drugs, so without a diverse pool of volunteers, clinical trial results can be skewed.

In oncology trials that took place between 2008 and 2018, only 63% included information about participants' race. Of those that reported, more than 76% of participants were White, while 18.3% were Black, 6.1% were Hispanic and only 3.1% of Asian heritage were represented. There is an obvious underrepresentation by non-whites.

So what are the underlying issues in why it is difficult to recruit non-white volunteers to participate in clinical trials? One factor claimed by Rear Admiral (RADM) Richardae Araojo, FDA Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) is, "a lack of trust because of past historical abuses." Other barriers include cultural differences, language comprehension, religious influences, health literacy, not understanding what it means to participate in a clinical trial, and even a lack of awareness about what a clinical trial is.

Economic barriers disproportionately affect minority groups including insurance that may not cover costs incurred in a clinical trial such as imaging and supportive medications, cost of traveling to trial sites, and the ability to take time off of work or to arrange for childcare.

To mitigate these factors, RADM Araojo urges doctors and researchers to involve patients from the ground up, including trial design, site locations, and finding ways to recruit diverse populations. Their inclusion cannot be just an afterthought. She stresses, "Consistent and continued community engagement through working with cultural ambassadors, faith-based organizations, and with trusted leaders in the community are examples of efforts that have helped support diversity in clinical trials."

The FDA has also developed initiatives to encourage diversity in enrollment through hosting public meetings, developing tools, and issuing guidance documents, while the OMHHE has created strategies that include public service announcements, social media programs in Spanish, and educational materials.

“As clinical trials continue to modernize and evolve," she continues, "it offers new opportunities to reach diverse populations that we may not have reached in the past. So, a multisector approach, partnerships, engaging patients and providers, and sharing of best practices are opportunities to continue to advance racial and ethnic minority inclusion in clinical trials."

This multifaceted approach is needed to ensure that the drugs approved through the clinical trial process have a standard efficacy for all ethnic groups.

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