"Patient-reported outcomes, which include topics such as symptom burden and quality of life issues, are integral to the successful treatment of cancer patients," says Jeff Sloan, Ph.D., Mayo Clinic oncology researcher and symposium course director. "While for many years clinicians have been collecting PRO data and using it in various ways, until recently there was no overarching guidance on how and when to use it. We hope discussions and manuscripts from this symposium regarding the FDA guidance will help to change that."
Writing teams composed of representatives from around the world are preparing articles discussing the five major themes covered in the draft guidance: Conceptual Issues; PRO Instrument Selection; PRO Instrument Development Issues; Validation of PROs; and Analysis, Interpretation and Reporting Results Based on PROs. These documents will form the basis of discussion at the meeting, and all attendees will be encouraged to fully participate in evaluating and modifying what will then be presented to the FDA as recommendations.
"This is a chance for clinicians, industry representatives, scientists, regulatory agency personnel and patient advocates to all sit down at the same table and come up with ways to make the FDA guidance work," says Dr. Sloan. "I would encourage everyone with some stake in clinical trials to consider attending this meeting."