FDA New Rules For Broader Representation In Drug Testing

The FDA has made progress in promoting diversity in clinical trials. Recently, the agency published a draft guidance providing more information on how sponsors can develop Diversity Action Plans to ensure trial participants better reflect the populations that will use the products once they are available.

This new guidance, relevant to some phase 3 trials, replaces a previous, less detailed document issued in April 2022.

Rohit Nambisan, CEO and co-founder of Lokavant mentioned that Congress aimed to address the underrepresentation of minority patient populations in clinical research by requiring companies to submit plans for enrolling trial participants that accurately represent the patient populations for the products being tested. He noted that the FDA’s recent draft guidance is the initial step in implementing the new law.

Testing drugs on a diverse population ensures their safety across various patients. For instance, older adults may take longer to metabolize certain medications, increasing the risk of toxic reactions at standard dosages. Genetics can also influence drug metabolism.

The FDA’s Diversity Action Plans require sponsors to identify the ideal patient mix for a trial and outline a detailed recruitment strategy.

The new guidance clarifies which trials require diversity plans, the specifics of plan formatting, timing and submission, and the waiver process.

An FDA press release stated that the guidance encourages sponsors and investigators to consider the many dimensions of clinical trial diversity, extending beyond age, ethnicity, sex, and race, to enroll populations representing the patients who will be treated if the product is approved.

While pharmaceutical companies have generally supported diversity initiatives, including new participants in clinical research remains challenging, and many trials fail to meet diversity goals. Dr. Pamela Tenaerts, chief science officer at Medable, noted that determining the right combination of participants might be challenging for some trial designs but straightforward for others, particularly those for common conditions with well-understood patient demographics.

A recent Office of Inspector General report found that many NIH-funded trials did not attract enough people from underrepresented groups. However, the new guidance might present an additional hurdle for sponsors to overcome.

Nambisan expressed that although the FDA’s requirement for diversity plans within protocol designs will eventually benefit clinical sciences and humankind, clinical trial sponsors now face increased complexity, more data to manage, and higher risk.

Though the guidance is not final, organizations should prepare for its implementation and note similar state laws emerging nationwide. Julie Ozier, senior vice president of IRB review at Advarra, pointed out that Washington State passed a Diversity in Clinical Trials Bill requiring investigators to collaborate with community-based organizations and use FDA-recognized methods to identify and recruit underrepresented populations.

The FDA’s 2022 draft guidance required organizations to create Diversity Action Plans, and after analyzing 91 oncology submissions, the agency found that 13% omitted required elements. Tenaerts advised drugmakers to review these findings to avoid common mistakes.

While many companies already have diversity plans, changes to real-world outcomes will likely be gradual. Ozier predicted that with the draft guidance outlining the requirements for diversity action plans, more organizations would develop better plans, but meaningful results and improved representation in clinical trials would take time to achieve.