Experts to address use of patient-reported outcomes in clinical trials at joint Mayo-FDA forum

Dozens of medical research experts will assemble Feb. 23-25, 2006, in Chantilly, Va., to discuss how patient-reported outcomes (PROs) should be developed, validated, interpreted and used in clinical trials. This symposium, jointly sponsored by Mayo Clinic and the U.S. Food and Drug Administration (FDA), is a forum for discussion and feedback regarding the soon-to-be-released FDA draft guidance for industry on using PRO measures to support medical product labeling claims. The draft guidance will be published in the Federal Register with an invitation for public comment.

"Exactly how we incorporate patient-reported outcomes into cancer research has been murky for a long time. It is a great opportunity to bring clarity and consensus to the issue," says Jan Buckner, M.D., Mayo Clinic medical oncologist and chair of the North Central Cancer Treatment Group (NCCTG). The group specializes in researching methods of treating and preventing cancer, as well as methods to alleviate the side effects of cancer and cancer treatments. "Clinicians and researchers around the world are going to be able to use the information presented at this symposium as a guide for how and when to use patient-reported outcomes. It's really a step forward for all of us."

Five writing teams composed of experts in PRO research will present papers on the major themes covered in the draft guidance: conceptual issues; PRO instrument selection; PRO instrument development issues; validation of PROs; and analysis, interpretation and reporting results based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. Each document will include recommendations on the most appropriate methods of how PROs should be incorporated into clinical trials, and will advocate additional research needed to overcome limitations currently faced in the application of PROs. Attendees will have the opportunity to discuss and comment on these papers as well as the FDA's draft guidance.

FDA's experts in PRO measurement in clinical trials also wil

Contact: Elizabeth Zimmermann
Mayo Clinic

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