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Oncology: Use and Usefulness of PRO Endpoints in Oncology Trials
Session Chair(s)
Alan Shields, PHD
Vice President Patient Centered Outcomes
Adelphi Values, United States
Despite the value of PRO data and regulatory encouragement for PRO endpoints in cancer trials, the promise of integrating the patient perspective into oncology drug approval and labeling remains largely unfulfilled. The meeting session, Use and Usefulness of PRO Endpoints in Oncology Trials, chaired by Alan Shields, is designed to provide attendees with examples, insights, and practical knowledge regarding a) the value use of PRO-based endpoints as primary efficacy endpoints in oncology trials and b) the value of PRO endpoints in open label trials that are routinely conducted for cancer treatments. This knowledge training session will include presenters to characterize the perspective of patients, drug developers, trial methodologists, clinicians, and the FDA.
Program Committee Representatives: Stephen Joel Coons, Critical Path Institute and Katarina Halling, AstraZeneca, Sweden