Unpacking FDA’s New Guidance On Collecting Patient Experience Data

The drug development industry’s focus on the discovery and therapeutic aspects of precision and genetic medicine, as well as the continued need for virtual, remote patient visits, has highlighted the fundamental role that individual patients have in the life cycle of development. As the industry continues to shift toward making a patient-centric approach the standard, the FDA is also releasing new guidance documents to help influence these changes. This past month, the FDA released one of what is to be four new guidances providing a general overview of patient-focused drug development. This new guidance, titled Guidance 1: Collecting Comprehensive and Representative Input, is primarily centered on how to collect patient experience data in patient-focused drug development. The purpose of this article is to summarize each component of Guidance 1 to highlight some of the main points addressed in the guidance and detail how the guidance may impact sponsors of clinical trials.