FDA Issues New Guidance to Increase Minority Representation in Clinical Trials

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Ethnic diversity in clinical trials has been lacking for years. Multiple companies have recognized this lapse and have made changes accordingly, but less has been done on a larger regulatory scale. Now, the U.S. Food and Drug Administration is urging drugmakers to submit racial and minority recruitment plans when designing their studies.

The importance of clinical diversity of patients in studies has been in the spotlight for some time. On Tuesday, the FDA issued new guidance, titled “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials,” that calls for companies to submit a Race and Ethnicity Diversity Plan to include more underrepresented minority populations in the United States. In a press release, FDA Commissioner Robert M. Califf said that the U.S. population is highly diverse, and the industry needs to ensure meaningful representation of racial and ethnic minorities in clinical trials.

In the United States, minority populations have historically been underserved by the life sciences community, particularly in clinical studies. Some minority populations have shown a disproportionate burden for certain diseases, including heart disease and strokes, and the need for an increased variance of ethnicities and races in clinical trials was heightened by the COVID-19 pandemic due to the way the SARS-CoV-2 virus disproportionately impacted minority communities. Last year, a report in the New England Journal of Medicine revealed that the racial and ethnic minority groups most negatively impacted by COVID-19 are also the least represented in clinical studies.

Similarly, an analysis published in March by Trinity Life Sciences highlighted the underrepresentation of minorities in clinical studies. Although more than 40% of the U.S. population is made up of different ethnic minority groups, they make up only 5% to 10% of clinical trial populations.

Over the years, there have been studies that have shown medications that treat a broad population of patients are less effective in minorities, such as the asthma drug albuterol. As the FDA noted in its announcement, variations in genetic coding can make treatment more or less toxic for one racial or ethnic group than another. These variations can also make drugs like antidepressants and blood-pressure medications less effective for certain groups. By including more patients from diverse backgrounds in the studies, medications with greater efficacy for broader populations will be discovered.

The FDA noted the barriers to minority population participation in clinical studies, including a mistrust in the scientific community due to historical abuses, language and cultural differences, health literacy, religion and limited access. In February, Medable and CVS partnered to improve clinical trial diversity by taking advantage of Medable’s decentralized trial platform and linking it with the CVS MinuteClinic facilities across the country. 

“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,” Califf said in a statement.

There is also a concerted effort to include more minority patients in oncology studies. This includes the Cancer Moonshot project spearheaded by the Biden administration, which has set goals to increase minority representation. The addition of minorities is expected to address inequities in access to cancer screening, diagnostics and treatment across race, gender, region and resources.

Additionally, new guidance for oncology was developed by the FDA’s Oncology Center of Excellence's Project Equity. The guidance aims to ensure that data submitted to the regulatory agency supporting potential approval of oncology medical products “adequately reflects the demographic representation of participants for whom the medical products are intended,” the agency said.

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