The US Food and Drug Administration (FDA) has issued draft guidance highlighting recommendations for sponsors submitting Diversity Action Plans (DAPs) for clinical trials.
These plans aim to boost patient enrolment in clinical studies with historically underrepresented populations.
Diversity Action Plans
In its guidance, the agency explained that Diversity Action Plans are important because “consistent implementation of actions to improve representativeness in clinical studies can support more equitable and timely access to medical discoveries and innovations, improve the generalisability of results across the intended patient populations, improve our understanding of the disease and/or medical product under study, and inform the safe and effective use of the medical product for all patients”.
Diversity Action Plans are important because “consistent implementation of actions to improve representativeness in clinical studies can support more equitable and timely access to medical discoveries and innovations”
Within the guidance, FDA shared details the format and content of Diversity Action Plans, for which product submissions Diversity Action Plans are needed, as well as the process for sponsors intending to submit a DAP to the FDA.
For example, according to the guidance, sponsors must include their reasoning and aims for enrolling patients in their clinical study, separating age, ethnicity, sex and race of clinically relevant patient populations. The DAP should detail how the sponsor plans to meet those goals. The guidance encourages sponsors to consider diversity beyond typical specificities such as race or sex.
Requirement for Diversity Action Plans from sponsors follows new provisions of the Federal Food, Drug and Cosmetic Act added by the Food and Drug Omnibus Reform Act (FDORA) under section 3602. DAPs apply to certain clinical studies such as Phase III trials. Sponsors must submit these plans for studies which begin enrolment 180 days after the final guidance is published, according to FDA.
Significance of the new guidance
“These plans may help ensure that sponsors are thinking critically and intentionally about the many characteristics of the patient population they aim to treat when designing their clinical study,” commented Dr Richard Pazdur, Director of the FDA’s Oncology Center of Excellence and Acting Director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.
“Participants in clinical trials should be representative of the patients who will use the medical products,” remarked Dr Robert Califf, FDA Commissioner. “The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data we have about patients who will use the medical products if approved”.
FDA stated that comments on the Diversity Action Plan draft guidance, should be submitted within 90 days following its publication.
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