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Thoughts on the FDA Guidance to Assure Racial and Ethnic Diversity in Clinical Trials


On 13 April 2022 the Food and Drug Administration (FDA) issued a new draft guidance for ‘developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials.’ According to the FDA, this guidance expands on the agency’s previous guidances for industry to improve clinical trial diversity. A breakdown of the current and previous guidance on Diversity or Diversity Data in Clinical Trials is displayed in Table 1.

Awareness of the lack of diversity in clinical trials is important because approximately 20% of drugs have different effects depending on a patient’s ethnic diversity. Differences in drug response are attributed to polymorphisms in genes encoding drug-metabolizing enzymes (DMEs) and drug transporters. Polymorphisms directly influence pharmacokinetics and pharmacogenomics. It is important to understand the differences in genetic variants of DMEs and transporters that determine differences in the exposure, efficacy, and safety of drugs between ethnicities, which requires diverse representation in clinical studies. To date, clinical studies fall short of diverse representation.

  • African American/Black patients make up 13.4% of the population but only 5% of trial participants

  • Hispanic/Latinx patients make up 18.5% of the population but only 1% of trial participants

  • Non-Hispanic white patients make up 60% of the population but over 77% of trial participants

The recent FDA guidance is intended to increase racial and ethnic diversity by asking clinical trial sponsors and investigators to create a Race and Ethnicity Diversity Plan.

The draft guidance focuses on racial and ethnic inclusion, specifically naming the inclusion of “underrepresented racial and ethnic populations in the United States, such as Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native Hawaiian, and Other Pacific Islander, and other persons of color” (Sec 1). Also included in the draft guidance is language advising sponsors to “seek diversity in clinical trial enrollment beyond populations defined by demographics such as sex, gender identity, age, socioeconomic status, disability, pregnancy status, lactation status, and co-morbidity” (Sec 1).


The Eye Roll

According to FDA Commissioner Robert Califf, “The U.S. population has become increasingly diverse, and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health. Going forward, achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities.”

It's this statement, coupled with the prominent statement in the guidance itself: “This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations” that give me pause and demands a concerted effort not to roll my eyes and sigh the exasperation of the tired. It is a complete contradiction. It’s nice that the FDA has been and continues to ‘think about’ this topic. But thoughts, feelings, and meditations don’t create change. It allows pillow-like comfort of “well, we tried, and we’ll continue to keep trying’” while not actually doing anything. Then, having the audacity to self-congratulate on the absolute nothing that results from fluffy, safe talk like this.

Once again, this is performative, and written to be ‘safe’ and ‘comfortable’ as previous FDA guidance has been in the past. In this draft guidance, the FDA acknowledges the previous sets of recommendations to improve clinical trial diversity (see Table 1), And, despite these guidances, there has been little, if any, improvement in increasing the number of clinical trials that adequately account for diverse populations or diverse data sets. In a 2022 study, researchers analyzed records from all US clinical trials registered on from March 2000 to March 2020, and found that among the 20,692 US-based trials with reported results, only 43% (8,871/20,692) reported any race/ethnicity data. Minorities are still underrepresented in trials with modest improvement over time. This data tells me previously finalized FDA guidance related to improve diverse representation in clinical studies has been ineffective.

While not all trial phases require a drug intervention or treatment where FDA approval is required, it is not breaking news that there is a lack of diversity in clinical studies, regardless of Phase or FDA involvement.

What is lacking in the current draft guidance and in previously finalized guidance is

accountability. There are no consequences if the draft and other guidance’s are not followed. On the very first page of the draft guidance, an “out” is declared. This is why there has been no significant improvement in ethnic diversity and representation in clinical trials – no accountability and no follow though; Instead, there is more rhetoric, more statements of good intention, more public announcements of ‘commitment to diversity’ followed zero action or enforceability. The lack of enforceability means that there is no real incentive to truly taking steps to change and improve representation in clinical studies.

Instead, there is a collective congratulatory pat on the back for good PR and good intention.

I am not impressed.

-Dr. Tania M.

Table 1

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