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How Sponsors Can Address Inclusion Across Gender Identity, Comorbidities, and Beyond
While workshops to solicit stakeholder feedback for the Food and Drug Omnibus Reform Act (“FDORA”) diversity plan mandate are still pending—and while waivers may be available for certain cases—clinical trial sponsors should prepare for the possibility of diversity plan recommendations becoming diversity plan requirements.
As such, many sponsors are wondering how to recruit, engage and retain hard-to-find patients.
In this playbook, we explore trends and how sponsors can adapt their protocols to be more inclusive of more people:
FDORA: Key implications for clinical trial diversity
Defining and goal setting for demographic subgroups
Best practices to diversify protocols, recruitment and engagement