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26th April 2022

FDA pushes for ethnic diversity in clinical trials

A new draft guidance from the FDA recommends sponsors develop and submit a Race and Ethnicity Diversity Plan

Researches and clinical trials are the backbones of medicine – and if medicine is for all, then the topic of discussion is pertinent. Long-established social and economic inequalities increase the health risks and vulnerabilities for Blacks, Indigenous, and People of Colour communities. Recent data accentuate the relative absence of this set of people in clinical trials.

According to a recent report from Trinity Life Sciences, a life science consulting firm, Black Americans make up 13% of the population but only 5% of clinical trials. It also reported a worse gap for the Hispanic and Latino Americans who make up 19% of the U.S population but hardly have a representation of up to 1% in clinical representation. Ethnic diversity in clinical trials has been lacking for years.

Racial and ethnic minorities are frequently either not represented or underrepresented in biomedical research even though they have a disproportionate burden for many diseases. This implies that clinical trials may be inaccurate in reflecting the diversity of the population that will eventually receive approved treatment. Many companies have recognized this lapse and have made attempts to change the narratives; however, less has been done on a larger regulatory scale.

Having an adequate and appropriate representation of the necessary races and ethnicities in infectious disease research is a critical component in the attempt to increase vaccine confidence, acceptability, and uptake of future approved products.

A Step in the Right Direction

In a guidance released in November 2020 titled “Enhancing the Diversity of Clinical Trial Populations ─ Eligibility Criteria, Enrolment Practices, and Trial Designs,” the United States Food and Drug Administration made recommendations on how to improve trial diversity. However, these guidelines lacked accountability measures. Knowing the potential solutions to the lack of diversity in clinical trials without any mandate to implement them is of little benefit.

On April 13, expanding on the agency’s previous guidance for the industry to improve the diversity of clinical trials, FDA issued a new draft guidance to the industry for developing plans to enrol more participants from underrepresented racial and ethnic populations. This came a while after Trinity Life Sciences prodded the FDA to devise enrolment requirements that take the racial demographic of certain diseases under consideration when working on a related clinical trial. This aims to help boost diversity in studies.

The Food and Drug Administration is encouraging drug makers to make and submit racial and ethnic recruitment plans for clinical trials early in the drug development process in an attempt to boost participation among underrepresented races and ethnicities.

In this new draft guidance titled, “Diversity Plans to Improve Enrolment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials,” the agency recommends sponsors develop and submit a “Race and Ethnicity Diversity Plan,” based on a framework outlined in the guidance.

The variation in genetic coding can make treatment either more or less difficult for a racial or ethnic group. Similarly, some drugs may be less effective in certain groups of people due to such variation. This shows that including more patients from diverse backgrounds in the studies will lead to the production of medications with greater efficacy for broader populations.

Barriers to Participation

The FDA has however identified some barriers to participation among racial and ethnic groups which include mistrust of the clinical research system due to historical abuses, language and cultural differences, health literacy, religion, limited access, inadequate recruitment and retention efforts in the aspects of trial design, and time and resource constraints for participants. Lack of awareness and knowledge about what participating in clinical trials means and entails may also impede the show of interest among racial and ethnic minority. There are far more barriers that can be mentioned.

The agency, through its operations, has shown absolute commitment to increasing the enrolment of diverse populations in medical product and drug development, and it aims to continue engaging with federal partners, medical product manufacturers, healthcare professionals, and health advocates to reach the set goal.



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