In April 2022, the FDA released draft guidance with recommendations for drug developers and clinical trial researchers. The guidance highlights gaps in equitable clinical trials and outlines the need for Race and Ethnicity Diversity Plans. Clinical trials are meant to ensure the safety and efficacy of a drug or medical device. Understanding demographic differences in clinical trial participants is vital for gathering accurate data and bridging gaps in medicine. The demographics of the targeted treatment population should be reflected in the research population, but this is often not the case.  

Ethnic minority groups have been consistently underrepresented in clinical trials. Chronic medical conditions, such as high blood pressure and diabetes, impose variable and often significantly higher burdens across minority ethnic and racial groups. For example, Black patients are 2 times more likely to die from diabetes complications and cardiovascular disease than White patients. Life expectancy also varies drastically across different races and is the lowest for American Natives at 65 years old. This highlights the need for inclusive and diverse clinical trials to improve health outcomes for all races and ethnicities.  

When patients’ race and ethnicity is collected during a clinical trial, these data must be reported to Clinicaltrials.gov. This requirement, which was enacted in 2017, increased the percentage of trials with corresponding race/ethnicity data. However, collecting this information is still not standard and is not reported in an estimated 10% of clinical trials. Furthermore, the collection of race/ethnicity data does not actually ensure equitable volunteer participation. In the last 5 years, despite the collective acknowledgement and increased recruitment efforts, research participation among Black and Hispanic patients has decreased and hit record lows.  

In April of 2022, the FDA released draft guidance in an attempt to address the lack of clinical trial diversity. The draft guidance, titled “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry,” recommends that medical product sponsors create a Race and Ethnicity Diversity Plan. The diversity plan should outline clinical trial enrollment goals for historically underrepresented racial and ethnic populations. The FDA encourages sponsors to develop enrollment goals by assessing the burden of disease across different groups of people. These plans should ideally be submitted alongside Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications.  

The recent Consolidated Appropriations Act (HR2617), which became law in December 2022, includes the Food and Drug Omnibus Reform Act of 2022 (FDORA). Subtitle F, Chapter 1 highlights the cross-cutting provisions for clinical trial diversity. The law requires drug sponsors conducting phase 3 studies to submit a diversity action plan along with a study protocol. Section 3602 of FDORA outlines requirements for the FDA’s updated diversity action plan guidelines.  

According to the updated requirements, diversity action plans must include:  

• The sponsor’s goals for clinical study enrollment, separated by age group, sex, and racial and ethnic demographic characteristics of clinically relevant study populations 
• The rationale for enrollment goals including disease prevalence and/or incidence, pharmacokinetics or pharmacogenetics, or patient population for a specified disease or condition 
• How the sponsor intends to meet their enrollment goal  

The 2023 Consolidated Appropriations Act strengthens the FDA’s efforts to increase diversity in clinical trials and ensure patient populations are properly reflected. The FDA will begin submitting annual reports summarizing their experience with sponsor’s action plans within 2 years of FDORA’s enactment.  Pfizer’s revolutionary journey developing the Covid-19 vaccine highlights the benefits of diversity in clinical trials. In CEO Albert Bourla’s book Moonshot, he describes the importance of emphasizing diversity and ensuring Covid-19 vaccine clinical trials included volunteers reflective of the population impacted by the virus. Hopefully, the research community will continue to build trust with marginalized communities and develop clinical trials reflective of the diverse US population. Improving clinical trial diversity is a major step toward health equity and closing the gap in health disparities for minority populations.  

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