A Mayo/FDA meeting regarding guidance on patient-reported outcomes (PRO) Discussion, Education, and Operationalization FDA to release guidance for assessing.

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Presentation transcript:

A Mayo/FDA meeting regarding guidance on patient-reported outcomes (PRO) Discussion, Education, and Operationalization FDA to release guidance for assessing PRO’s in all clinical trials (4th quarter 2005?) Meeting co-sponsored with FDA to: provide a focused process to facilitate discussion among all stakeholders educate stakeholders on background, content, and concerns provide an opportunity for input delineate ways to best operationalize the guidance into clinical trials February 23-25, 2006, DC (Westfields Marriott, Chantilly, VA, 7 miles from Dulles) FDA to release guidance for assessing PRO’s in all clinical trials (4th quarter 2005?) Meeting co-sponsored with FDA to: provide a focused process to facilitate discussion among all stakeholders educate stakeholders on background, content, and concerns provide an opportunity for input delineate ways to best operationalize the guidance into clinical trials February 23-25, 2006, DC (Westfields Marriott, Chantilly, VA, 7 miles from Dulles)

Mayo/FDA Meeting on PRO: Faculty Paper I: Conceptual Issues Margaret Rothman, Ph.D.Johnson & Johnson Joe Cappelleri, Ph.D.Pfizer Bonnie Teschendorf, Ph.D.American Cancer Society Joe Lipscomb, Ph.D.Emory University Philippe Beltram, Pharm.D.Sanofi-Aventis Paper II: PRO Instrument Selection Michelle Halyard, M.D.Mayo Clinic Scottsdale Dave Cella, Ph.D.Northwestern Claire Snyder, Ph.D.Johns Hopkins Maria Watson, Ph.D.GlaxoSmithKline Joseph Jackson, Ph.D.Bristol-Myers Squibb Paper III: PRO Instrument Development Issues Ralph Turner, Ph.D.Phase V Technologies Charles CleelandMD Anderson Bhash ParasuramanAstra Zeneca Lisa Rowenhorst, Pharm DAmgen Dr. Alexandra QuittnerUniversity of Miami

Mayo/FDA Meeting on PRO: Faculty Paper IV: PRO Validation Marlene Frost, Ph.D.Mayo Clinic Rochester Ron Hays, Ph.D.UCLA Joseph Stauffer, Ph.D.Alpharma Astra Liepa, PharmDEli Lilly & Company Bryce Reeve, Ph.D.National Cancer Institute Paper V: Interpretation of Results Based on PRO’s Jeff Sloan, Ph.D.Mayo Clinic Rochester Pennifer Erickson, Ph. D.Pennsylvania State Univ. Nancy Santanello, M.D.Merck Harry Guess, Ph.D.Univ. of North Carolina Dennis Revicki, Ph.D.MEDTAP International FDA response: Laurie Burke, Jane Scott, Donald Patrick et al Canadian Perspective: David Osoba, M.D. et al European Perspective: Neil Aaronson, Ph.D. et al