TL43: PRO and COA Experiences: Regulatory and Patient Priorities and Processes
Wen-Hung Chen, FDA  *Laura Lee Johnson, FDA  Scott Komo, FDA 

Keywords: Patient Reported Outcomes, Clinical Outcome Assessments

What are statisticians’ roles in developing, approving, and qualifying patient reported outcomes (PROs) and other clinical outcome assessments (COAs) used as part of medical product development? PDUFA V has challenged the FDA’s clinical and statistical capacity to address submissions involving COAs. This roundtable will build on topics from the April 1, 2015 public meeting on COAs. Topics that can be discussed include how to incorporate the patient voice in drug development using well-defined and reliable patient-centered outcome measures, general advice about common problems, data request issues and potential solutions, and evolving standards for COA use and collaborative processes for COA development and dissemination.