For decades, there has been a lack of diversity in clinical trials for new drugs and medical treatments. This lack of representation of different racial and ethnic groups has contributed to health disparities and an incomplete understanding of how new therapies may impact diverse populations. However, a new law passed aims to change that by requiring drug companies to develop specific plans to enroll more underrepresented groups in their clinical trials.
What is the FDORA Act?
The new requirements are part of the Food and Drug Omnibus Reform Act of 2022, known as the FDORA Act. As Dr. Lola Fashoyin-Aje, a medical oncologist and FDA official, explained in a BDO panel discussion, “FDORA amends the Food, Drug and Cosmetic Act” to give the FDA more authority to ensure diversity in clinical trials.
“We are very excited about having this new tool to really engage sponsors on very early discussions about their strategy in very specific ways that really keeps them accountable to particular goals and to the measures that they will be implementing to achieve those goals,” said Dr. Fashoyin-Aje.
How does the FDORA Act work?
Under FDORA, drug companies must submit detailed diversity plans outlining their goals and strategies for enrolling representative populations that reflect the real-world demographics of the disease being studied. This is a notable shift from past clinical trials that often underrepresented certain racial and ethnic minorities.
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“Before the trial is initiated, we have a plan from the sponsor to commit to certain enrollment goals for the trial,” Dr. Fashoyin-Aje stated. “I think that going through that exercise lends to a much more thoughtful approach to selecting trial sites and monitoring enrollment to meet those benchmarks.”
Why the FDORA Act is important
The importance of achieving diversity in clinical trials cannot be overstated, according to Dr. James Powell, co-founder of knoRX and a leader in efforts to boost minority participation in trials. As he noted, lack of diversity can lead to key gaps in understanding how a drug may impact different populations.
“If a drug to treat heart failure works in one part of the population but not in another part of the population, then that could contribute to some of the disparities we see in some conditions,” Dr. Powell said.
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While the FDORA Act represents an important step forward, both Dr. Powell and Dr. Fashoyin-Aje acknowledged the challenges that remain. These include determining appropriate diversity enrollment targets based on disease prevalence rather than just overall population percentages.
There are also operational hurdles, such as expanding trial sites beyond just major medical centers to increase access for underrepresented communities. As Dr. Fashoyin-Aje stated, “We can’t be going to the same ivory tower institutions to do these trials.”
Despite the difficulties ahead, FDORA’s new requirements have raised optimism that more inclusive clinical trials could lead to better understanding of how drugs perform across diverse groups – a crucial factor in ultimately reducing healthcare disparities.
“We are seeing that industry is really putting time into addressing this issue,” said Dr. Fashoyin-Aje. “When things are a requirement, it makes people pay attention more than when something is just a recommendation.”
