Patients Rising Now submitted comments to the FDA on the recently released guidance on incorporating patient experience data in drug development. In clinical trials, the main areas of focus are the efficacy of a treatment as well as its safety. While these are undoubtedly critical components, the experience of patients participating in these trials is either not recorded or not given the attention it rightly deserves. The FDA’s new guidance memo not only encourages increasing the collection of this information, but also using that information to create quantitative metrics to better understand that information. Patients Rising Now’s comments applauded the FDA for issuing this memo and offered further recommendations.
Patients Rising Now Submits Comments on Patient Experience
