Dec 12, 2023
Devra Densmore, principal consultant at Elevate Advocacy, explains the FDA has released guidance to drive Diversity Action Plans to ensure that clinical trials are representative of affected patients. Emphasizing the need for a thoughtful and strategic approach to diversity, Devra highlights inclusivity includes accessibility and listening to patient advocates to meet the needs of marginalized communities.
Devra explains, "This is a very exciting time where, by releasing these guidance documents, the FDA is setting a standard for the expectation that industry and study sponsors have a very intentional approach to ensuring that their studies are representative. That the therapies or devices that are created are beneficial for all people affected by the conditions that those medications and devices are supposed to solve for."
"So, for me, these Diversity Action Plans are a really exciting opportunity for industry to think about what it wants to do in this space. How can it contribute to making sure that health equity is realized within the clinical development space? Are studies actually reflective of the communities that are most impacted by disease? Are medications or devices that are created actually safe and effective for the people who need to use them, especially the people who need to use them the most?"
#ElevateAdvocacy #HealthEquity #PatientFocusedDrugDevelopment #PFDD #PatientsFirst #ClinicalTrials #ClinicalResearch #DiversityActionPlan
