FDA dips its toe into the world of patient-reported outcomes for cancer trials
While acknowledging the challenge of ensuring patient-reported outcome (PRO) data in cancer drug applications are consistent and of high quality, the FDA on Wednesday outlined its expectations for how this data on symptoms and functional impacts may aid the agency’s benefit/risk assessments.
Cancer drug trials typically employ standardized efficacy assessments of overall survival and tumor reduction measures, in addition to closely tracking any adverse events to evaluate a new drug’s safety and efficacy balance. But the FDA is also looking to better employ a core set of PROs to address disease symptoms, symptomatic adverse events, and physical function, all of which may be important contributors to a patient’s quality of life.
Premium subscription required
Unlock this article along with other benefits by subscribing to one of our paid plans.