A Mayo/FDA meeting regardingA Mayo/FDA meeting regardingguidance on patient-reported outcomes (PRO)guidance on patient-reported outcomes (PRO)Discussion, Education, and OperationalizationDiscussion, Education, and Operationalization

A Mayo/FDA meeting regardingA Mayo/FDA meeting regardingguidance on patient-reported outcomes (PRO)guidance on patient-reported outcomes (PRO)Discussion, Education, and OperationalizationDiscussion, 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: FacultyMayo/FDA Meeting on PRO: FacultyMayo/FDA Meeting on PRO: FacultyMayo/FDA Meeting on PRO: Faculty

Paper I: Conceptual IssuesMargaret Rothman, Ph.D. Johnson & JohnsonJoe Cappelleri, Ph.D. PfizerBonnie Teschendorf, Ph.D. American Cancer SocietyJoe Lipscomb, Ph.D. Emory UniversityPhilippe Beltram, Pharm.D. Sanofi-Aventis

Paper II: PRO Instrument SelectionMichelle Halyard, M.D. Mayo Clinic ScottsdaleDave Cella, Ph.D. NorthwesternClaire Snyder, Ph.D. Johns Hopkins Maria Watson, Ph.D. GlaxoSmithKlineJoseph Jackson, Ph.D. Bristol-Myers Squibb

Paper III: PRO Instrument Development IssuesRalph Turner, Ph.D. Phase V TechnologiesCharles Cleeland MD AndersonBhash Parasuraman Astra ZenecaLisa Rowenhorst, Pharm D AmgenDr. Alexandra Quittner University of Miami

Mayo/FDA Meeting on PRO: FacultyMayo/FDA Meeting on PRO: FacultyMayo/FDA Meeting on PRO: FacultyMayo/FDA Meeting on PRO: Faculty

Paper IV: PRO ValidationMarlene Frost, Ph.D. Mayo Clinic RochesterRon Hays, Ph.D. UCLAJoseph Stauffer, Ph.D. AlpharmaAstra Liepa, PharmD Eli Lilly & CompanyBryce Reeve, Ph.D. National Cancer Institute

Paper V: Interpretation of Results Based on PRO’sJeff Sloan, Ph.D. Mayo Clinic RochesterPennifer Erickson, Ph. D. Pennsylvania State Univ.Nancy Santanello, M.D. MerckHarry Guess, Ph.D. Univ. of North CarolinaDennis Revicki, Ph.D. MEDTAP International

FDA response: Laurie Burke, Jane Scott, Donald Patrick et alCanadian Perspective: David Osoba, M.D. et alEuropean Perspective: Neil Aaronson, Ph.D. et al