Experts to Address Use of Patient-Reported Outcomes in Clinical Trials at Joint Mayo-FDA Forum

Wednesday, January 25, 2006

ROCHESTER, Minn. — 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U.S. Food and Drug Administration (FDA), is a forum for discussion and feedback regarding the soon-to-be-released FDA draft guidance for industry on using PRO measures to support medical product labeling claims. The draft guidance will be published in the Federal Register with an invitation for public comment.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Five writing teams composed of experts in PRO research will present papers on the major themes covered in the draft guidance: conceptual issues; PRO instrument selection; PRO instrument development issues; validation of PROs; and analysis, interpretation and reporting results based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 Attendees will have the opportunity to discuss and comment on these papers as well as the FDA's draft guidance.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 will participate in this meeting. Laurie Burke of the Office of New Drugs in FDA's Center for Drug Evaluation and Research, who spearheaded the development of this draft guidance document, is a member of the organizing committee. She notes, "It is vitally important that FDA's draft guidance is widely discussed among PRO researchers who understand the challenges of measuring the patient's perceptions in clinical trials. This forum allows an open discussion that will be documented so the FDA can use the feedback to improve and finalize policy in this area."

The importance of identifying appropriate methods for developing, validating and using PROs in clinical trials is underscored by two additional meetings scheduled for the fall that will continue the discussion. "By the end of the year, we'll have moved the state of the science to be able to say 'this is what should be done,'" says Jeff Sloan, Ph.D., Mayo Clinic researcher and co-director of the symposium. "All of us involved in the writing of these seminal documents are thrilled to be part of this process."

For more information on the symposium, go to www.qolpro.org.

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