Monday, July 15, 2024

Clinical Trials Diversity: FDA Pushes Concrete Plans for Greater Inclusion

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Clinical trials are set to become more diverse as the Food and Drug Administration (FDA) has taken significant steps by releasing a comprehensive draft guidance. This new document provides a detailed roadmap for pharmaceutical companies to develop Diversity Action Plans (DAPs), ensuring that trial participants more accurately reflect the populations who will use the products once they reach the market. This guidance, applicable to some phase 3 trials, replaces a previous, less detailed version issued in April 2022.

The need for diversity in clinical trials is critical for ensuring that medications work safely and effectively across different demographics. For example, older adults might metabolize drugs slower, increasing the risk of adverse reactions, and genetic differences can also affect drug efficacy and safety. By mandating diversity, the FDA aims to rectify the historical underrepresentation of minority populations in clinical research.

Clinical Research Diversity: Lokavant CEO Highlights Importance of FDA’s New Guidance

Rohit Nambisan, CEO and co-founder of Lokavant, highlighted the importance of this initiative, stating, “Congress sought to fix the underrepresentation of minority patient populations in clinical research by requiring companies to submit their plans for enrolling trial participants that truly represent the patient populations for the products tested in the trial, otherwise known as diversity action plans. The recent FDA’s draft guidance is the first step in carrying out the new law.”

The FDA’s new guidance specifies which trials need diversity plans, the format and timing for these plans, and the waiver process. Sponsors are encouraged to consider various dimensions of diversity, including age, ethnicity, sex, race, and other factors to ensure that trial populations are representative of those who will be treated if the product is approved. The guidance also emphasizes the importance of identifying the ideal patient mix and outlining a detailed recruitment strategy.

According to the FDA, “The guidance urges sponsors and investigators to consider the many dimensions of clinical trial diversity, even those that extend beyond age, ethnicity, sex, and race to enroll populations that represent the patients who will be treated if the product is approved.”

While the pharmaceutical industry generally supports diversity initiatives, achieving these goals can be challenging. Many trials have historically fallen short of diversity targets. Dr. Pamela Tenaerts, chief science officer at Medable, pointed out that determining the right participant mix can be straightforward for some trial designs but more complex for others.


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A recent report from the Office of Inspector General found that many NIH-funded trials were not attracting enough participants from underrepresented groups, highlighting the ongoing challenges in this area. The new guidance adds another layer of complexity for sponsors, who must now manage additional data and risks.

Nambisan acknowledged the benefits and challenges, saying, “While the FDA’s requirement of diversity plans baked into protocol designs shall eventually yield many important benefits to clinical sciences and humankind, clinical trial sponsors are now saddled with even more complexity to manage, more data to absorb, and more risk.”

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Organizations should also be aware of similar state laws emerging across the country. For instance, Washington State has passed a Diversity in Clinical Trials Bill requiring investigators to collaborate with community-based organizations and use FDA-recognized methods to recruit underrepresented populations.

The FDA’s 2022 draft guidance called for Diversity Action Plans, and an analysis of 91 oncology submissions revealed that 13% omitted required elements. To avoid common missteps, Tenaerts recommends that drugmakers review these findings.

Julie Ozier, senior vice president of IRB review at Advarra, noted that while many companies already have diversity plans, meaningful results and improved representation in clinical trials will take time. She stated, “Now that we have a draft guidance outlining the requirements for diversity action plans, we will see more organizations developing smarter plans. But I think it will take time to see meaningful results and improved representation in clinical trials.”

The FDA’s detailed guidance on Diversity Action Plans marks a significant step toward improving the representation of minority populations in clinical trials. While the path forward involves challenges, the potential benefits for clinical science and patient care are substantial. As pharmaceutical companies adapt to these new requirements, the hope is that clinical trials will become more inclusive, leading to safer and more effective treatments for all patients.


Resource: Food and Drug Administration, June 26, 2024

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