FDA reveals diversity action plan guide for clinical trials
The FDA has published its long-awaited update to guidance to make sure clinical trials more closely reflect the range of patients that might be treated with a new therapy in the real world.
The draft guidance spells out the way trial sponsors should structure diversity action plans (DAPs) to increase enrolment of subjects from historically underrepresented communities, something that was mandated by Congress in the FDORA and DEPICT Acts of 2022.
Although over 40% of the US population is currently comprised of ethnic and racial minorities, typically only 5% to 10% of clinical trial participants represent any minority population, and that could expose non-white people to the risk that a new therapy is ineffective or potentially even harmful.
For example, a 2022 report from IQVIA found that Black/African American participation in trials had been declining over the past decade, which has been linked to mistrust of the healthcare system in the US.
The DAP guidance aims to address that disparity and others, so that trial enrolment is representative of age group, sex, and racial and ethnic characteristics.
Included in the new document is information on what products should have a DAP, what information should be included in the plan, ways to request a waiver, and when and how it should be submitted to the FDA.
For example, a DAP must be prepared for pivotal trials of a new drug, although, the regulator also recommends that sponsors develop a diversity strategy “across the entire clinical development programme, including in early studies.”
They must specify the sponsor’s rationale and goals for clinical study enrolment – separated by the age group, ethnicity, sex, and race of clinically relevant study populations – and describe how the sponsor intends to meet those goals.
“With FDORA, there is now a requirement for sponsors to submit diversity action plans. 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,” said Richard Pazdur of the FDA’s Center for Drug Evaluation and Research (CDER).
“The agency’s draft guidance is an important step – and one of many ongoing efforts – to address the participation of underrepresented populations in clinical trials to help improve the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.”
The guidance is out for comment until 26th September and, if adopted, will replace earlier guidance on DAPs published by the FDA in 2022. Once finalised, trial sponsors will have 180 days to come into compliance.
US Representative Anna Eshoo (D-CA), Health Subcommittee Ranking Member and a driving force behind the DEPICT Act, said that clinical trials have failed to achieve a level of diversity that reflects the American population for decades.
“I applaud the FDA’s steps to implement my legislation to address this inequality and look forward to the agency finalising guidance on the [DAPs] to ensure clinical trials are representative of all Americans.”
Photo by Daria Nepriakhina 🇺🇦 on Unsplash
