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The FDA’s latest draft guidance on diversity and inclusion in clinical trials

Diversity within the US continues to grow, with four in 10 Americans identifying with a race or ethnic group other than white. Racial and ethnic minorities face a disproportionate burden of diseases and are also frequently underrepresented in biomedical research and clinical trials. The US Food and Drug Administration (FDA) recently announced new draft guidance for life science companies on increasing diversity and inclusion in clinical trials to improve enrollments of underrepresented racial and ethnic populations. This guidance, Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials, recommends that sponsors submit a race and ethnicity diversity plan to the FDA for medical products for which an IND or IDE submission is required, as well as clinical studies to support marketing submission. This further expands the FDA’s commitment to increasing the enrollment of diverse populations in trials to ensure the generalizability of study results for the population that will ultimately use the product once it is approved.

Data from clinical trials provide the basis for evaluating whether a medical product is safe and effective. Therefore, clinical trial data should reflect the racial and ethnic diversity of the population that will be using the treatment. Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native Hawaiian and Other Pacific Islanders, and other persons of color are underrepresented in clinical trial populations. FDA Commissioner Robert M. Califf, MD, explained that “ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health.” While this draft guidance does not explicitly cover diversity in sex, gender identity, age, socioeconomic status, disability, pregnancy status, lactation status, and co-morbidity, the FDA encourages sponsors to submit plans to ensure adequate participation among all underrepresented subgroups to boost diversity and inclusion in clinical trials.

Developing a Race and Ethnicity Diversity Plan to accelerate diversity and inclusion in clinical trials

For drug development, the Race and Ethnicity Diversity Plan should be shared no later than when the organization is seeking feedback regarding clinical trial plans, which is often during the end of Phase 2 (EOP2) meeting. Organizations can also request FDA feedback on their plan by including questions in a formal milestone meeting request.

The plan should define enrollment goals for underrepresented racial and ethnic participants, indicate the potential safety or efficacy differences among these participants, and outline the plan to collect data and explore differences between subgroups. The FDA provided five recommended elements of the plan to boost diversity and inclusion in clinical trials.

  1. Provide an overview of the disease using available data to demonstrate the pathophysiology of the disease in underrepresented racial or ethnic populations.
  2. Describe the planned trials or studies, specifically including how the trial may address inclusion of underrepresented racial and ethnic populations.
  3. Define and provide justification for plans to enroll participants from underrepresented racial and ethnic populations.
  4. Define, in detail, the trial operations that will be implemented to enroll and retain underrepresented racial and ethnic participants, specific trial enrollment and retention strategies, plans for collection of race and ethnicity data in clinical trials, metrics to ensure enrollment goals are met, and actions to be implemented if enrollment goals are not met.
  5. Discuss the status of meeting enrollment goals and make updates to the diversity plan as needed.

Understand barriers that impede racial and ethnic diversity in clinical trials

To improve enrollment and retention of specific racial and ethnic groups and accelerate diversity and inclusion in clinical trials, longstanding barriers need to be addressed. These barriers include mistrust of the clinical research system resulting from historical abuses, such as the Tuskegee study. However, other factors impede participation, such as inadequate recruitment and retention efforts for clinical trials or study designs that inadvertently exclude underrepresented populations. In addition, social determinants such as time constraints, financial resources, caregiver or family responsibilities, and transportation can sometimes impede participation.

This guidance expands on the FDA’s 2016 guidance, Collection of Race and Ethnicity Data in Clinical Trials

The FDA’s latest step to increase clinical trial enrollments from underrepresented racial and ethnic populations expands on the agency’s 2016 guidance titled, Collection of Race and Ethnicity Data in Clinical Trials. The 2016 guidance detailed how life science organizations should collect and present race and ethnicity data in FDA submissions. Its latest guidance recommends that organizations develop and submit a plan to address the inclusion of underrepresented patients.

Leveraging real-world data to develop the clinical trials diversity plan

The FDA recognizes that it may be challenging to set enrollment goals due to limited data on the incidence and/or prevalence of the disease across diverse racial and ethnic populations. The FDA encourages sponsors to leverage published literature and real-world data.

To support sponsors as they seek to leverage real-world data and socio-behavioral determinants of health data to meet diversity and inclusion goals, Clarify Health has developed a unique technology, Clarify Trials. Clarify Trials is a real-world evidence-based software solution that leverages over 400 social determinants of health (SDoH) factors to help life sciences companies increase the recruitment of diverse, underrepresented, and niche patient populations. It also allows clinical trial teams to identify and engage with physicians that treat diverse communities through insights into primary care and specialist referral patterns—the same insights used by leading health systems to optimize their provider networks. Clarify’s life sciences software is acclaimed by Frost & Sullivan for being the most innovative RWE solution within the life sciences industry.