Medidata Solutions reposted this
Corporate Governance, Enterprise Risk Management, and Corporate Compliance Executive (GRC)
Achieving stronger diversity in clinical trials is crucial to developing smarter and more precise treatments. Recently released draft guidance from the FDA requires the creation and publication of Diversity Action Plans (DAPs). Check out our main takeaways below: 1) Medidata Solutions views the DAP as a critical document in the advancement of clinical research. We are encouraged by the focus on enrollment and retention of relevant and diverse study participants. This guidance is critical for advancing healthcare outcomes by prioritizing insights and protocols that reflect different demographic characteristics, including age, sex, and racial, and ethnic backgrounds. 2) We are in support of the FDA’s suggestion for sponsors to publicize their DAPs; this will significantly enhance transparency and public trust, further driving our industry to better support patients. 3) Notably, the draft guidance states that sponsors should make use of appropriate available sources in their DAPs, like registries. With the increased adoption of #DecentralizedClinicalTrials, we see a greater opportunity for sponsors to interact directly with both enrolled and prospective patients, while gathering critical data that helps ensure these registries are demographically representative. Feel free to leave a comment or send me a DM if you'd like to chat further. #ClinicalResearch #FDADraftGuidance #Medidata
FDA published a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies”: https://lnkd.in/gNczUwNA This draft guidance describes: ➡Format and content of Diversity Action Plans ➡The medical products and clinical studies for which a Diversity Action Plan is required ➡Timing and process for submitting Diversity Action Plans to the FDA ➡Waiver requests To learn more about this guidance and how to submit comments, visit: https://lnkd.in/eT5AhNTP
