BCN Staff – May 2, 2022 – Amid concerns about the lack of Black and other minorities that participated in COVID-19 clinical trials, the U.S. Food and Drug Administration issued a new draft guidance to industry on April 13 for developing plans to enroll more participants from underrepresented racial and ethnic populations.
The new FDA order expands on the agency’s previous guidances for industry to improve clinical trial diversity. The most recent guidance was handed down in November 2020 when the Biden administration touted more diversity and inclusion in trials for all medical products related to the highlight touted “Cancer Moonshot” program.
That five-year program was started by the National Cancer Institute (NCI), which is part of the National Institutes of Health, to help researchers better understand and treat cancer. The Moonshot Biobank will ask cancer patients across the U.S. to donate biospecimens or blood and small pieces of tissue removed during medical procedures and associated health information.
The NCI guidance recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollment of underrepresented populations in their clinical trials.
“Over the past few decades, FDA has promoted enrollment practices that would lead to clinical trials that better reflect the population most likely to use the drug if the drug is approved, primarily through broadening eligibility criteria,” FDA officials said. “Despite these efforts, challenges to participation in clinical trials remain, and certain groups continue to be underrepresented in many clinical trials.”
In making the case for overhauling the nation’s clinical trial testing, FDA Commission Dr. Robert Califf said the U.S. population has become increasingly diverse, and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health,”
“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,” said Califf. “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.”
Despite having a disproportionate burden for certain diseases, racial and ethnic minorities are frequently underrepresented in biomedical research, the FDA say. Clinical trials provide a crucial base of evidence for evaluating whether a medical product is safe and effective; therefore, enrollment in clinical trials should reflect the diversity of the population that is ultimately going to use the treatment.
It is known that biological differences exist in how people respond to certain therapies. For example, variations in genetic coding can make a 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.
This draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials,” recommends that sponsors of medical products develop and submit a Race and Ethnicity Diversity Plan to the agency early in clinical development, based on a framework outlined in the guidance.
Barriers to participation among racial and ethnic groups may include mistrust of the clinical research system due to historical abuses, aspects of the trial design such as inadequate recruitment and retention efforts, frequency of study visits, time and resource constraints for participants, transportation and participation conflicting with caregiver or family responsibilities. In addition, language and cultural differences, health literacy, religion, limited access within the health care system and a lack of awareness and knowledge about what a clinical trial is and what it means to participate may impact clinical trial participation among racial and ethnic minority populations.
The FDA said it remains committed to increasing enrollment of diverse populations in medical product and drug development and will continue to engage with federal partners, medical product manufacturers, healthcare professionals and health advocates to reach this important goal.
To support the FDA’s efforts to advance diverse participation, the Office of Minority Health and Health Equity created the “Diversity in Clinical Trials Initiative,” which includes an ongoing public education and outreach campaign to help address some of the barriers preventing diverse groups from participating in clinical trials. Barriers to participation are addressed through a variety of culturally and linguistically tailored strategies, tools and resources such as: educational materials in multiple languages, a dedicated webpage with public service announcements and videos, social media outreach and ongoing stakeholder engagement, collaborations and partnerships.
In February, the Biden Administration revived the Cancer Moonshot initiative to further expand cancer prevention, detection, research and patient care efforts across the federal government. The FDA Commissioner serves as a member of the White House Cancer Cabinet, comprised of departmental agencies and components organized to develop a unified strategy in the fight against the disease. One of the goals of the Cancer Moonshot is to address inequities in access to cancer screening, diagnostics and treatment across race, gender, region and resources. The FDA’s guidances on increasing diversity in clinical trials are aligned with the Cancer Moonshot goals.
The draft guidance was developed by the Oncology Center of Excellence’s Project Equity, which aims to ensure that the data submitted to the FDA for approval of oncology medical products adequately reflects the demographic representation of participants for whom the medical products are intended. As this guidance applies to all medical products, the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health also contributed to this collaborative effort.
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