It is widely discussed that the clinical trial industry suffers from a lack of diversity in clinical trial outcomes. “Diversity” represents a wide-range of descriptions, such as race and ethnicity, sex, gender identity, age, socioeconomic status, and disability status, to name a few. The FDA has issued several sets of recommendations to improve clinical trial diversity and defines a diverse population to include these wide-ranging definitions. Some populations (women and older adults) already have more specific guidance documents regarding the FDA’s line of thinking for inclusion.  

The most recent Guidance toward clinical trial diversity– Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials– is targeted toward intentional, proactive development of plans to improve enrollment of participants from underrepresented racial and ethnic populations. The guidance describes that the agency’s motivation to release this guidance document is due to the lack of representation of these populations in clinical research reflecting, in part, a broader issue regarding access to health care. 

The April 2022 Guidance expands on its guidanceCollection of Race and Ethnicity data in Clinical Trials (October 2016). The 2016 Guidance recommended that sponsors develop and submit a plan, for discussion to the agency, that addresses inclusion of clinically relevant populations. The expanded guidance provides more clarity about what details to include in a Race and Ethnicity Diversity Plan. Of note, the FDA recommends that such plans be submitted to the investigational new drug (IND) or the investigational device exemption (IDE) application, and discussed with the FDA as soon as practicable during medical product development. 

The guidance describes the desired contents of Race and Ethnicity Diversity Plans in the document. These include: 

  • Defined enrollment goals for underrepresented racial and ethnic participants based on pre-specified protocol objectives of the investigation. They should include sufficient PK and PD data from a diverse population in drug development, and relevant factors for device performance (e.g., phenotypic, anatomical, or biological) should be collected to inform differential effects across a diverse population. (For example, variation in skin pigmentation can affect the performance of certain devices, such as pulse oximeters.) 
  • Planned assessment of race and ethnicity in addition to other covariates with known potential to affect safety and effectiveness. 
  • When there are data to indicate a medicinal product may perform differentially across the population based on factors associated with race or ethnicity, the Plan should specify the study design features that will support analyses that will inform the safety and effectiveness of the medicinal product in the relevant racial and ethnic populations. 
  • The Plan should outline the sponsor’s plan to collect such data throughout the product lifecycle, and not just during pivotal trial(s) or studies. 
  • If there are limited data of the epidemiology of disease across diverse racial/ethnic populations, it is noted that it may be appropriate to set enrollment goals based on demographics in the overall population with the disease or condition. 

The Guidance document includes a table with recommended elements of the Plan based on the desired content described above. 

With this expanded guidance, there is more clarity from the FDA on the intention to include diverse racial and ethnic populations. We wonder, are you seeing efforts toward increased participant diversity as a result of the Guidance document? Do you feel this will push the industry into studying more diverse populations in clinical trials? Please provide your thoughts; we would love to include them in future blogs on this topic!