Draft guidance to improve US clinical trial diversity

The new clinical trial guidance asks sponsors to submit a Race and Ethnicity Diversity Plan outlining how they plan to enrol participants from underrepresented populations.

Multicoloured silhouettes standing on top of a cartoon earth - idea of diversity and inclusion

The US Food and Drug Administration (FDA) has published a new draft guidance to support companies in enrolling more ethnically diverse trial populations. The guidance outlines developing plans to enrol more participants from underrepresented racial and ethnic populations into clinical trials.

Commenting on the release, FDA Commissioner Dr Robert Califf, stated: “The US 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. This guidance also further demonstrates how we support the Administration’s Cancer Moonshot goal of addressing inequities in cancer care, helping to ensure that every community in America has access to cutting-edge cancer diagnostics, therapeutics and clinical trials.”

Despite having a disproportionate burden for certain diseases, racial and ethnic minorities are frequently underrepresented in biomedical research. Clinical trials provide a crucial base of evidence for evaluating whether a medical product is safe and effective; therefore, it is critical that they reflect the diversity of the population that is ultimately going to use the treatment. It is also well known that biological differences exist in how people respond to certain therapies, these factors may impact drug toxicity or the efficacy of medications in certain racial or ethnic groups.

There are numerous potential barriers to participation among racial and ethnic groups, from mistrust of the clinical research and healthcare systems to inadequate recruitment and retention efforts, time and resource constraints to language and cultural differences. Limited access within the health care system and a lack of knowledge about what a clinical trial is and what it means to participate may also impact clinical trial participation among racial and ethnic minority populations.

The new draft guidance recommends that sponsors of medical products develop and submit a Race and Ethnicity Diversity Plan to the agency early in clinical development, based on a framework outlined in the guidance. 

In addition to the guidance, the Office of Minority Health and Health Equity created the “Diversity in Clinical Trials Initiative,” which includes an ongoing public education and outreach campaign to help address some of the barriers preventing diverse groups from participating in clinical trials. The Biden Administration has also revived the Cancer Moonshot initiative to further expand cancer prevention, detection, research and patient care efforts across the federal government. One of the goals of the Moonshot is to address inequities in access to cancer screening, diagnostics and treatment across race, gender, region and resources.

The draft guidance was developed by the Oncology Center of Excellence’s Project Equity, which aims to ensure that the data submitted to the FDA for approval of oncology medical products adequately reflects the demographic representation of participants for whom the medical products are intended. As this guidance applies to all medical products, the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health also contributed to the new clinical trial diversity guidance.