Welcome/Opening Remarks FDA Guidance on Patient Reported Outcomes: Discussion, Dissemination, and...
Transcript of Welcome/Opening Remarks FDA Guidance on Patient Reported Outcomes: Discussion, Dissemination, and...
Welcome/Opening RemarksWelcome/Opening Remarks
FDA Guidance on Patient Reported Outcomes: FDA Guidance on Patient Reported Outcomes:
Discussion, Dissemination, and OperationalizationDiscussion, Dissemination, and Operationalization
Chantilly, VA, February 23 – 25, 2006Chantilly, VA, February 23 – 25, 2006
Jeff. A. SloanMayo Clinic Comprehensive Cancer Center
Rochester, MN
I was a lot younger when we I was a lot younger when we started planning this meeting…started planning this meeting…
In fact we were all a lot younger…In fact we were all a lot younger…
marlenemichele lauriejane
kristy martha
ThanksThanks
• FDA & Mayo partnershipFDA & Mayo partnership• Laurie Burke, Jane ScottLaurie Burke, Jane Scott
• Writers and ReviewersWriters and Reviewers
• Funding from Corporate SponsorsFunding from Corporate Sponsors
• North Central Cancer Treatment GroupNorth Central Cancer Treatment Group
• Mayo QOL TeamMayo QOL Team• Marlene Frost, Michele HalyardMarlene Frost, Michele Halyard• Kristy Vierling, Kara CurryKristy Vierling, Kara Curry
• Martha Hoag and Mayo CMEMartha Hoag and Mayo CME
Corporate SponsorsCorporate Sponsors
LEADER:LEADER: AmgenAmgenEli LillyEli LillyTakedaTakeda
PATRON:PATRON: GlaxoSmithKlineGlaxoSmithKline Genetic, Inc.Genetic, Inc. Roche Laboratories, Inc.Roche Laboratories, Inc. WyethWyeth
CONTRIBUTOR: CONTRIBUTOR: Merck Research LaboratoriesMerck Research LaboratoriesNeoPharm, Inc.NeoPharm, Inc.
SyllabusSyllabus
• Schedule, Faculty bios, financial Schedule, Faculty bios, financial disclosures disclosures
• FDA draft guidanceFDA draft guidance
• Draft manuscripts, produced before Draft manuscripts, produced before the guidance was releasedthe guidance was released
• Slide presentationsSlide presentations
Housekeeping: FacilitiesHousekeeping: Facilities
• Breaks / MealsBreaks / Meals
• Phones, copier, fax, messaging, wirelessPhones, copier, fax, messaging, wireless
• Emergency phone number: Emergency phone number: 703-818-0300703-818-0300
Work Hard: Play HardWork Hard: Play Hard
• Reception tonight 6:00 – 9:00Reception tonight 6:00 – 9:00
• Dinner hosted by George and Martha Dinner hosted by George and Martha WashingtonWashington
• Can still sign up at registration deskCan still sign up at registration desk
Work Hard: Play HardWork Hard: Play Hard
Reception tomorrow 7:00 – 9:30Reception tomorrow 7:00 – 9:30• Hockey/Movie Night in CanadaHockey/Movie Night in Canada• Heavy hors d’oeuvresHeavy hors d’oeuvres• TriviaTrivia• ““Strange Brew”Strange Brew”
Meeting Survival FacilitationMeeting Survival Facilitation
• Massage therapistsMassage therapists
• Free chair massageFree chair massage
• Signup at registration deskSignup at registration desk
Primary Meeting GoalsPrimary Meeting Goals
• Provide a focused process to facilitate discussion among all stakeholders
• INPUT and FEEDBACKINPUT and FEEDBACK
• Present conclusions of each paperPresent conclusions of each paper
• Delineate ways to best operationalize the guidance into clinical trials
Meeting FormatMeeting Format
• 90 minutes per paper90 minutes per paper
• 20-30 minute presentation of findings20-30 minute presentation of findings
• 0-5 minute FDA commentary 0-5 minute FDA commentary
• 40-60 minute moderated Q&A / discussion40-60 minute moderated Q&A / discussion
• Audience may submit written questionsAudience may submit written questions
• Team members / FDA panelists respondTeam members / FDA panelists respond
Ground RulesGround Rules
• Brevity is the soul of wit: 1-minute wisdomBrevity is the soul of wit: 1-minute wisdom
• Disagreements are not personal Disagreements are not personal
• Keep to time scheduleKeep to time schedule
• We have a path already chosen, the time for We have a path already chosen, the time for going back to square one has past going back to square one has past
• People can be nominated for massagesPeople can be nominated for massages
Mayo/FDA Meeting on PRO: FacultyMayo/FDA Meeting on PRO: Faculty
Paper I: Conceptual IssuesMargaret Rothman, Ph.D. Johnson & JohnsonPhilippe Beltram, Pharm.D. Sanofi-AventisJoe Cappelleri, Ph.D. PfizerJoe Lipscomb, Ph.D. Emory UniversityBonnie Teschendorf, Ph.D. American Cancer Society
Paper II: PRO Instrument SelectionMichele Halyard, M.D. Mayo Clinic Dave Cella, Ph.D. NorthwesternJoseph Jackson, Ph.D. Bristol-Myers SquibbClaire Snyder, Ph.D. Johns Hopkins Maria Watson, Ph.D. GlaxoSmithKline
Paper III: PRO Instrument Development IssuesRalph Turner, Ph.D. Phase V TechnologiesCharles Cleeland, Ph.D. MD AndersonJoel Kallich, Ph. D. AmgenBhash Parasuraman, Ph.D. Astra ZenecaAlexandra Quittner, Ph.D. University of Miami
Mayo/FDA Meeting on PRO: FacultyMayo/FDA Meeting on PRO: Faculty
Paper IV: PRO ValidationMarlene Frost, Ph.D. Mayo Clinic Ron Hays, Ph.D. UCLAAstra Liepa, PharmD Eli Lilly & CompanyBryce Reeve, Ph.D. National Cancer InstituteJoseph Stauffer, Ph.D. Alpharma
Paper V: Interpretation of Results Based on PRO’sJeff Sloan, Ph.D. Mayo Clinic Amylou Dueck, Ph.D. Mayo Clinic Pennifer Erickson, Ph. D. Pennsylvania State Univ.Harry Guess, Ph.D. Univ. of North CarolinaDennis Revicki, Ph.D. MEDTAP InternationalNancy Santanello, M.D. Merck
Mayo/FDA Meeting on PRO: FacultyMayo/FDA Meeting on PRO: Faculty
FDA Response: Laurie Burke, Jane Scott, Donald Patrick et al
Canadian Perspective (NCIC): David Osoba, M.D. et al
European Perspective (EORTC): Neil Aaronson, Ph.D. et al
European Perspective (ERICA): Catherine Acquadro, Ph.D. et al