In June 2024, the FDA released updated draft guidance on diversity in clinical trials, building upon previous efforts to ensure clinical research reflects the populations it aims to serve. This guidance represents a crucial milestone in the pursuit of more equitable and scientifically robust research. Here, we analyze key aspects of the guidance and outline the potential implications.
Key updates in FDA’s 2024 diversity guidance for clinical trials
The latest draft guidance expands the scope of diversity considerations in clinical trials. While previous iterations focused primarily on race and ethnicity, it has now been expanded to include age and birth sex as key factors to consider in trial design and recruitment.
It’s a great step forward, but it’s important to recognize that there’s still room for growth. The guidance doesn’t explicitly address other crucial aspects of diversity such as socioeconomic status, disability, or gender identity. While these factors are mentioned as considerations, they aren’t given the same emphasis as the primary demographic categories.
What is the effective date for FDA's 2024 diversity guidance?
With the current iteration being in draft form only, we recommend that organizations begin to think now about how they will take action once guidance becomes final. Once the final version is in place, it will apply to clinical studies where enrollment commences after 180 days. It is crucial to note that the diversity action plans are intended for phase three or pivotal trials. The FDA is expecting discussion around these plans and a tangible plan to be in place by the end of phase two, but certainly before engagement with the pivotal or phase three registrational trial.
For programs with high potential to go straight to approval, especially in oncology, we advise engaging with the FDA as early as possible. Not necessarily at the first in human stage, but around the time of locking down a dose.
Key elements of a diversity action plan under FDA's 2024 diversity guidance
The guidance outlines several crucial elements that should be included in a diversity action plan:
- Enrollment goals
- Rationale for these goals
- Specific measures to achieve the goals
- The sentiment from the FDA is to provide an actionable plan t o which they can provide feedback.
Some of the practical measures suggested in the guidance include:
- Engaging with advocacy and community groups
- Providing cultural competency training for site staff
- Offering local language translations of trial materials
- Reducing participant burden through measures like transportation support and reimbursement
- Strategic site selection to access diverse populations
- Implementing decentralized clinical trial (DCT) elements
- Precision for Medicine is wholly aligned with these measures and encourage their implementation across many trials to enhance access and reduce patient burden, in addition to those with specific diversity goals.
What are limitations of FDA’s 2024 Diversity Guidance?
While the guidance represents significant progress, it does have some limitations. As mentioned earlier, it doesn’t fully address all aspects of diversity. Other important groups, such as those defined by pregnancy, disability status, and socioeconomic status, are not explicitly included. This omission could limit the comprehensiveness of diversity efforts in clinical trials, leaving some patient groups underrepresented.
Another limitation is that this is guidance, not a mandate. As with all guidance, the first page states that this is not legally binding. However, there are mechanisms for enforcement, particularly in oncology. For instance, if the application put forward is not reflective of the patient population being treated, we have seen post-marketing commitments being issued with greater frequency across oncology.
Impact of FDA’s diversity guidance on clinical trial Sponsors and the wider industry
For sponsors, this guidance means that considering diversity should be an integral part of trial design from the earliest stages. Touching everything from the protocol to site selection, community engagement and more, it should be built into the fabric of clinical research.
This focus on diversity has the potential to improve recruitment via engagement with many who may not have had access to research opportunities in the past. In turn, offering these trials to more people benefits the broader patient community by helping bring new drugs to market more swiftly.
Long-Term Benefits of FDA’s 2024 Diversity Guidance
The long-term benefits of this guidance are substantial. Ensuring clinical trials reflect the populations we intend to treat with these novel therapeutics is not only the right thing to do, but it’s also scientifically logical and grounded in reason. It has the potential to generate more robust clinical data and improve health outcomes across different demographic groups.
By making our trials representative of the populations we aim to treat, we can enhance the quality and applicability of our research, ultimately leading to better health outcomes for all patients.
Final thoughts
This guidance marks a notable step forward in equitable and scientifically sound clinical research, providing a clear framework for sponsors to enhance trial population diversity. It will be crucial that this is approached as an opportunity to fundamentally improve how we conduct clinical research and develop new therapies. Only then can potential benefits be truly accessible to all.
