Over the past few years, the topic of diversity in biomedical research has been a theme discussed across events, media, and even pending legislation. New FDA guidance should have health researchers, and particularly clinical trial sponsors paying attention.
So, what do clinical researchers need to know about the FDA’s updated Diversity Plan guidance? This article explores five main takeaways.
The guidance specifically emphasizes racial and ethnic demographic characteristics of study populations – but the FDA recognizes diversity is broader than race and ethnicity.
The FDA guidance is clearly a step that demonstrates that diversity in biomedical research is a priority.
While the FDA’s recommendations are specific to racial and ethnic demographics, the agency acknowledges that there is other work to be done and goes further by recommending that clinical trial sponsors seek to achieve diversity in other areas as well. The agency notes other factors, including:
- Sex
- Gender identify
- Age
- Socioeconomic status
- Disability
- Pregnancy status
- Lactation status
- Co-morbidity
Will future FDA guidance begin to incorporate these other demographics? It’s certainly possible, and so researchers should think broadly about creating processes that will be able to support an expansion.
The FDA guidance recommends that clinical trial sponsors create and submit a formal race and ethnicity diversity plan
While the FDA clarifies that clinical trial sponsors may discuss approaches to enrolling diverse participants at any time in product development, the agency outlines that sponsors should submit their Diversity Plan as early as possible.
Why is this an important takeaway point for researchers?
The emphasis on an early communication of the Diversity Plan should remind researchers that increasing the diversity of participant populations requires a shift in approach. There may be a higher burden in order to achieve diversity than a study team expects, and so early planning can mitigate such a risk.
Further, the creation of a Diversity Plan doesn’t guarantee that any clinical trial or research program will hit the outlined goals. In order to remain in compliance, researchers should remember that diversity planning should come early in health research.
The FDA is specific and clear about what should be included in the recommended Diversity Plan.
In a helpful move, the FDA includes an overview and table of the components of the recommended Diversity Plan. Researchers – regardless of their research focus area, medical product or not – could begin to produce a template plan based on what the FDA has shared.
The Diversity Plan components include:
- Overview of the Disease/Condition
- The pathophysiology of the disease or condition in underrepresented racial and ethnic populations
- Variations across racial and ethnic populations in the applications or uses of available prevention, screening, or diagnostic strategies and treatments for the disease or condition
- The current understanding of any similarities or differences in the disease associated with unrepresented racial and ethnic populations
- Scope of Medical Product Development Program
- Study design, study population (including study eligibility criteria), endpoints and, the expected geographic locations of the trials or studies and how these aspects of the trial or study may specifically address inclusion of underrepresented racial and ethnic populations
- Summarize any differential findings from clinical pharmacology studies that may be associated with certain racial and ethnic populations and/or other relevant information
- Goals for Enrollment
- Outline the underrepresented racial and ethnic populations
- Define goals for enrollment of these underrepresented racial and ethnic participants (e.g., based on the epidemiology of the disease and/or based on a priori information that may impact outcomes across racial and ethnic groups; and where appropriate, leverage pooled data sources or use demographic data in general population)
- Enrollment and Retention Strategies
- Sponsors should detail the specific tactics they will implement to enroll and retain underrepresented racial and ethnic participants in the planned trial(s) or studies, as well as how they plan to use data to characterize safety, efficacy, and optimal dosage in these participant
- Sponsors must also describe specific trial enrollment and retention strategies, like
- Site location and access (e.g., language assistance for persons with limited English proficiency, reasonable modifications for persons with disabilities, and other issues such as transportation);
- Sustained community engagement (e.g., community advisory boards and navigators, community health workers, patient advocacy groups, local healthcare providers, etc.)
- Reducing burdens due to trial/study design/conduct (e.g., number/frequency of study-related procedures, use of local laboratory/imaging, telehealth)
- Sponsors should also outline how they will measure diverse participant enrollment goals are achieved
- Status of Meeting Enrollment Goals
- If updating the Diversity Plan over the clinical phase, the sponsor should update the current status against the enrollment goals.
- If the sponsor can’t achieve enrollment goals despite best efforts, discuss a plan and justification for collecting data in the post-marketing setting.
The new FDA guidance is focused on clinical trial sponsors – for now.
This is a clear directive that achieving participant diversity is a priority – but clinical trials for medical products need to plan immediate action.
Specifically, the FDA aims the new guidance at the following medical products:
- Medical products for which an IND submission is required
- Those for which clinical studies are intended to support a marketing submission under section 351(a) of the Public Health Service Act for a standalone Biologics License Application (BLA), or under 505(b)(1) or 505(b)(2)19 135 of the Federal Food, Drug, and Cosmetic Act (the 136 FD&C Act) for an NDA.
- Medical products for which an IDE is required
- Medical products for which clinical studies are intended to support a device marketing submission, whether a premarket notification (510(k)), premarket approval (PMA) application, a De Novo classification request, or a humanitarian device exemption (HDE) application
Health researchers should recognize that this evolving guidance will eventually expand beyond clinical trials to other areas of health research
There have been a number of recent government actions that point to a broader priority of improving diversity in health, and health research in particular.
Though the current FDA guidance is focused on clinical trials, researchers involved in longitudinal studies or observational studies, among other areas outside of clinical trials should still take notice.
We will learn much by watching this new FDA guidance take hold in clinical trials. We will discover new methods that work, and ones that fail – that will help us to enroll and retain more diverse participant populations in these other areas of biomedical research. And by planning to align research protocols with the FDA’s guidance, researchers will remain ahead of the curve.
For now, the FDA’s guidance is still a draft open for comments.
Need more information about how you can diversify your participant populations? Check out our recent webinar, Diversify Your Participant Population: Real Strategies that Work, now available on-demand.
