NCCTG Quality of Life Working Group: Progress Report

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(No Transcript)
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A Mayo/FDA meeting regardingguidance on
patient-reported outcomes (PRO)Discussion,
Education, and Operationalization

• FDA to release guidance for assessing PROs 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)

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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 J
oseph Jackson, Ph.D. Bristol-Myers
Squibb Paper III PRO Instrument
Development Issues Ralph Turner, Ph.D. Phase V
Technologies Charles Cleeland MD
Anderson Bhash Parasuraman Astra Zeneca Lisa
Rowenhorst, Pharm D Amgen Dr. Alexandra
Quittner University of Miami
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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, PharmD Eli Lilly
Company Bryce Reeve, Ph.D. National Cancer
Institute Paper V Interpretation of Results
Based on PROs 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