Diversity Action Plans Now Required by FDA for Sponsors of Certain Clinical Trials

The FDA has issued a new draft guidance document to help medical product sponsors develop Diversity Action Plans. This requirement stems from the Food and Drug Omnibus Reform Act (FDORA) which mandates sponsors to submit plans outlining how they will increase enrollment of participants from underrepresented populations in clinical trials.

The goal of Diversity Action Plans is to ensure that clinical trial data is more generalizable to real-world populations. By including a wider range of participants, researchers can gain a more comprehensive understanding of a drug or device's safety and efficacy across different demographics.

Here are some of the key points outlined in the FDA guidance document:

• Diversity Action Plans must specify goals for enrollment based on age, ethnicity, race, and sex of the target population for the investigational drug or device.

Plans should also include a rationale for the enrollment goals and a detailed explanation of how those goals will be met.

• The FDA encourages sponsors to consider broadening their diversity plans to include additional characteristics such as geographic location, socioeconomic status, disability status, and other relevant variables.

The FDA has emphasized the importance of enrolling a diverse group of patients in clinical trials:

“Participants in clinical trials should be representative of the patients who will use the medical products,” said FDA Commissioner Robert M. Califf, MD, in the press release. "The agency's draft guidance is an important step and one of many ongoing efforts to address the participation of underrepresented populations in clinical trials to help improve the data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."

By ensuring a more diverse participant pool in clinical trials, researchers can gain a more comprehensive understanding of a drug or device's safety and efficacy across different demographics. This ultimately translates to clinical trial data that is more generalizable to real-world populations, potentially leading to improved patient outcomes for a wider range of individuals.

The FDA's focus on Diversity Action Plans aligns perfectly with what we do at Maxis Clinical Sciences. While our main goal is to optimize research and development processes, we also offer a range of solutions that can help sponsors prioritize diverse patient populations.

Our suite of services includes Real-World Evidence, Market Access, Digital Transformation, Health Economics & Outcomes Research (HEOR), Revenue Management, Regulatory Submissions, Clinical Biometrics, Digital Health, Life Sciences Workforce, and Functional Service Provider.

So, how exactly does Maxis Clinical Sciences promote diversity in research and development?

• Data Integration and Analytics: Our team is skilled at using advanced techniques to gather insights from real-world evidence studies. These insights can then be used to design better clinical trials that represent a wider range of patients who will actually use the therapy.
• Patient Identification Strategies: We can help develop strategies to identify patients from underrepresented populations for future trials. This might involve working with patient advocacy groups and community healthcare providers.
• Regulatory and Strategic Guidance: We know the ins and outs of the ever-changing regulatory landscape, including the FDA and EMEA norms. This means we can provide valuable guidance on how to navigate these complexities.

By making diversity a priority throughout the research and development process, we work hand in hand with sponsors to gather robust clinical data that leads to better outcomes for everyone.

Get in touch with us today to talk about how we can help you achieve your research and development goals while also focusing on diversity and real-world applicability.

Reference:

1) Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies Guidance for Industry - Draft Guidance

2) FDA Guidance Provides New Details on Diversity Action Plans Required for Certain Clinical Studies - https://www.fda.gov/news-events/press-announcements/fda-guidance-provides-new-details-diversity-action-plans-required-certain-clinical-studies