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 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:
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.
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.
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:
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:
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.
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