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Involve Patients More Effectively in the Drug Development Process: Talk NERDY Feedback on FDA’s PFDD Draft Guidance

Published July 13, 2023

FDA Sign at its headquarters

On June 29, the Alliance for Aging Research, through our Talk NERDY program, provided feedback on the Food and Drug Administration’s (FDA) draft guidance titled “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making.” The letter highlights our support of the FDA’s initiative to involve patients in the drug development process and the need to incorporate patient perspectives. Our feedback notes the benefits of including patient input in research processes, study design, endpoint assessment, and evaluation of clinical meaningfulness.

In the letter, we suggest how to incorporate patients more effectively, noting the significance of early interactions with patients to establish a shared understanding and suggesting that the FDA consider the sustainability of treatment effect in Real World Evidence. Additionally, we recommend prioritizing primary data collection for endpoints and highlight the importance of considering assessments across a diverse patient population.

The Alliance’s Talk NERDY program offers educational opportunities for older adult patient advocates and their caretakers to learn about clinical research and its relevance to them. The program aims to enhance and expedite healthcare research for the aging population. The Alliance and the Talk NERDY program look forward to continuing to support the FDA’s Patient-Focused Drug Development efforts as they move forward.

Read the full June 29 letter.

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