The Food and Drug Administration (FDA) is announcing a public workshop entitled: Clinical Outcomes Assessment Development and Implementation: Opportunities and Challenges. The purpose of the public workshop is to provide updates on accomplishments, challenges, and ongoing efforts in the use of clinical outcome assessments (COAs), and plan for the future of COA development and utilization in drug development programs, including how to incorporate the patient voice in drug development using well-defined and reliable patient-centered outcome measures. The public workshop will also discuss standards for COA use and collaborative processes for COA development and dissemination.
Participation can be either in person attendance or by webcast. There is no fee to attend the public workshop, but attendees should register in advance. Space is limited, and registration for in person attendance will be on a first-come, first-served basis.
Before March 27, 2015, we ask all persons who wish to participate either in person or by webcast to Register online.
For those without Internet access, please contact Michelle Campbell at 240-402-6019.
If you have additional questions, please contact COApublicworkshop@fda.hhs.gov