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FDA Increases Calls for Manufacturers to Ensure Trial Diversity, but Does It Fall Short of Addressing Health Inequalities in Product Development?

The evidence is staggering on the unequal health burdens experienced by specific patient groups defined by ethnic, gender, or socioeconomic risk factors and the different health outcomes these groups may have in clinical trials. And while efforts have been made to address these inequalities, they are still falling short.

New FDA guidance: A significant step

Diversity, equity, and inclusion in trial development planning and enrollment practices are at the forefront of recent guidance from the United States Food and Drug Administration (FDA).1 This guidance is putting pressure on drug sponsors to ensure patients from underrepresented racial and ethnic groups are equally considered in clinical trials. Using real-world data (RWD) in product development is a critical industry tool for revealing healthcare disparities across different communities and calling attention to the intercorrelations (intersectionality) between different levels of risk for these groups.

The need for rich real-world data sources

The richer the RWD sources are, the more comprehensive the assessment of unequal health risk distribution.2 This, in turn, can provide a more informative picture of the patients most clinically relevant to trial development programs. The increasing emphasis on using reliable, fit-for-purpose RWD in product development would inevitably open the pathway to accelerate actions that promote equality, diversity, and inclusion in clinical trials.

However, specific data and methodological challenges are not well addressed in this guidance, including:

  • the lack of standardized definitions around health equity data,
  • the need for linkage of equity data across different sources to avoid biased assessments,
  • and the use of complex epidemiological causal models to disentangle the effect of multiple, commonly interrelated types of social disadvantages.

In addition, the trial enrollment strategies tested during the recent COVID-19 pandemic may facilitate the widespread use of innovative clinical trial models that create opportunities for more diverse and often isolated patients to participate in trials. However, even if diversity, equity, and inclusion guidance from the FDA and other organizations (ASCO, ACCC)3 begins to break down barriers to clinical trial recruitment and participation, these efforts fall short of addressing the well-known causes of health inequalities and recognizing that patient diversity is not only defined by racial or ethnic status.

An incomplete picture – where do we go from here?

The FDA recognizes this evidence gap and suggests in its guidance that future updates should put emphasis on ensuring that other patients’ groups, such as women from ethnic and racial minority groups, patients from low socioeconomic groups, people with disabilities, and patients living in rural areas, have been equally considered in a product’s evaluation by the agency. Until a complete mandate is put into action, this FDA guidance marks a significant step in addressing part of health inequalities but misses the mark in fostering full diversity in clinical trials.


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1 https://www.fda.gov/news-events/press-announcements/fda-takes-important-steps-increase-racial-and-ethnic-diversity-clinical-trials

2 https://pubmed.ncbi.nlm.nih.gov/35784688/

3 https://ascopubs.org/doi/full/10.1200/JCO.22.00754


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