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The FDA has taken another concrete step to increase diversity in clinical trials. The agency recently announced a long-awaited Draft Guidance It details how sponsors can develop diversity action plans to enroll trial participants who more fully represent the people who will use their products once they are on the market.
This guidance applies to some Phase 3 trials and replaces previous guidance. Few details Guidance Documents Issued in April 2022.
“The Congress Underrated “The FDA’s recent draft guidance aims to ensure diversity of underrepresented patient populations in clinical research by requiring companies to submit trial participant enrollment plans, also known as diversity action plans, that are truly representative of the patient population for which the product will be tested in the clinical trial,” said Rohit Nambisan, CEO and co-founder of Lokavant, a clinical trial information platform. “The FDA’s recent draft guidance is a first step toward implementing the new law.”
Testing drugs in diverse populations helps ensure that they work safely for a range of patients. senior citizenFor example, certain drugs may be metabolized more slowly, increasing the risk of toxic reactions at standard doses. Playing a role.
The FDA’s Diversity Action Plan asks sponsors to identify the ideal patient mix for their trials and outline detailed recruitment plans.
The new guidelines also detail the basics of which diversity plans are required, the plan’s format, timing, submission and waiver procedures.
“The guidance encourages sponsors and researchers to consider many aspects of diversity in clinical trials across age, ethnicity, sex and race, and to enroll populations that are representative of the patients who will be treated if the product is approved,” one pharmaceutical company report said. press release From the FDA.
“Now that we have draft guidelines outlining the requirements for diversity action plans, we hope more organisations will develop smarter plans.”
Julie Ogier
Senior Vice President of IRB Review at Advarra
Future tasks
The pharmaceutical industry in general Supported me Despite diversity efforts, recruiting new talent into clinical research is not always easy, and many trials fall far short of their diversity goals.
Determining the right mix of participants can be difficult for some trial designs but easier for others, such as common medical conditions where patient demographics are well known, according to Pamela Tennertz, PhD, chief scientific officer at Medable, a decentralized clinical trials software company.
Recent Report of the Office of the Inspector General I found that Many NIH-funded trials did not recruit enough participants from underrepresented groups.
But the new guidelines could create new hurdles for sponsors to overcome.
“FDA’s mandate to incorporate diversity planning into protocol design will ultimately provide many important benefits to clinical science and humanity, but it also creates additional complexity to manage, data to absorb, and risk for clinical trial sponsors,” Nambisan said.
While the guidance is not final, organizations should take note and prepare for similar state laws being enacted across the country, said Julie Ogier, senior vice president of IRB review at Advarra.
For example, Washington state Clinical Trial Diversity Bill “Researchers are urged to work with community groups to identify underrepresented populations using FDA-approved methods and recruit their participation,” she said.
FDA’s 2022 draft guidance requires organizations to develop diversity action plans, then 91 oncology articles analyzedThe study found that 13% of fields had mandatory information omitted, and Tennertz encourages pharmaceutical companies to look at these findings to avoid common mistakes.
Many companies are already implementing their own diversity plans, but the change to real-world results will be gradual.
“Now that we have draft guidelines outlining the requirements for diversity action plans, we will see more organizations develop smarter plans,” Ogier says, “but I think it will take time before we see meaningful results and improved representation in clinical trials.”
