• 
  Jacob Simpson
  , Breazeale Sachse & Wilson LLP
  

The U.S. Food and Drug Administration (FDA) recently published draft guidance encouraging sponsors of medical products to include underrepresented racial and ethnic minorities in clinical trial studies (Draft Guidance).[1] While not currently binding on sponsors, the Draft Guidance provides recommendations on an approach to developing a Race and Ethnicity Diversity Plan (Diversity Plan) aimed at ensuring that enrollment goals for clinical trials reflect the diversity of the population that may stand to benefit from the medical product.

The Draft Guidance is the latest in a series of guidance documents published by the FDA promoting diversity in clinical trials.[2] The Draft Guidance involves a collaborative effort of the Oncology Center of Excellence (OCE), the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Office of Minority Health and Health Equity (OMHHE).[3] As FDA Commissioner Robert M. Califf, M.D. explains, “[t]his 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.”[4] The FDA further states that, in many instances, certain diseases disproportionately impact certain racial and ethnicity minorities, yet those minorities are often underrepresented in clinical trials associated with those disease treatments.

The underrepresentation of racial and ethnic minorities in clinical trials was highlighted in a recent article from Bloomberg Health Law & Business titled, “Alzheimer’s Trials Exclude Black Patients at ‘Astonishing’ Rate.’”[5] The article tells the story of a 71-year-old African American living with Alzheimer’s who, despite his numerous attempts to participate in Alzheimer clinical trials, was repeatedly turned down. According to the article, Bloomberg News analyzed 83 Alzheimer’s disease drug trials posted on the government’s registration website (clinicaltrials.gov) or published in major medical journals.[6] The analysis found that while the Black population is twice as likely to develop Alzheimer’s disease as the White population, only 2% of patients included in reported Alzheimer’s clinical trials over the past decade were Black.[7] This racial and ethnic underrepresentation in clinical trials is an example of the lack of diversity that the Draft Guidance is designed to improve.

In an effort to help address the barriers that might prevent diverse groups from being represented in clinical trials, the Draft Guidance sets forth recommendations for sponsors of clinical trials to develop a Diversity Plan. The FDA recommends sponsors submit a Diversity Plan with any of the following submissions for drugs, biologics, and medical devices: investigational new drug (IND) application, biologics license application (BLA), new drug application (NDA), investigational device exemption (IDE), premarket notification (510(k)), premarket approval (PMA) application, De Novo classification request or humanitarian device exemption (HDE) application.[8]

The Draft Guidance provides a table summarizing the recommended elements of the Diversity Plan and notes that while the sample plan illustrates the type of information that should be included, the table is not intended to be a complete list of all measures that could be considered. The FDA recommends the Diversity Plan include specific content, a summary of which is provided below:

• Enrollment goals based in part on prespecified protocol objectives of the investigation. The plan should include an assessment of any data that may suggest the potential for a medical product to have differential safety or effectiveness associated with race or ethnicity.
• An explanation of the planned assessment of race and ethnicity along with other covariates that have known potential to impact the safety and effectiveness of the medical product.
• If the data suggests that race and ethnicity may affect the medical product’s performance differentially, include study design features that will support analysis of the safety and effectiveness in the different racial and ethnic populations.
• A strategy for collecting data on race and ethnicity that may impact safety and effectiveness not just during the pivotal studies, but throughout the entire product development life cycle.
• In situations where setting enrollment goals may be difficult due to limited available data, the FDA encourages sponsors to leverage real world data and published literature. If none exists, the enrollment goal may be appropriately set based on the overall population with the disease or condition being investigated.
• If there will be pediatric development of the medical product, include the planned clinical pediatric studies.[9]

The Draft Guidance also provides recommendations for the timing for submission of the Diversity Plan. For drug submissions, the FDA encourages sponsors to submit the Diversity Plan as soon as possible but no later than when seeking feedback on the applicable pivotal drug trial (often the End of Phase 2 (EOP2) meeting). The FDA encourages drug sponsors to seek feedback on the Diversity Plan by including questions in the milestone meeting request and meeting package. For submissions involving medical devices, the FDA recommends sponsors submit the Diversity Plan with the investigational plan in the IDE application. If a medical device sponsor would like to discuss the Diversity Plan prior to submission, the sponsor should use the Q-submission process. The Diversity Plan should also be included in a sponsor’s marketing application, along with an explanation of implementation successes and challenges associated with the Diversity Plan.[10]

In summary, the FDA continues to encourage race and ethnic diversity in clinical trials to ensure the populations most impacted by a disease are adequately represented in the study. Industry stakeholders should continue to monitor the regulatory guidance and may submit comments on the Draft Guidance until June 13, 2022. Comments can be submitted at regulations.gov and should cite Docket No. FDA-2021-D-0789.

Jacob Simpson is a partner in the Baton Rouge office of Breazeale Sachse & Wilson LLP and is a Board-Certified Health Law Specialist certified by the Louisiana Board of Legal Specialization. Jacob is a life sciences attorney and focuses his practice advising clients on legal issues related to human subject research, genetic research, research grants and contracts, and data privacy.

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