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

……at times it was challenging…at times it was challenging…

……but the guidance is out but the guidance is out and we are all hereand we are all here

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• FDA draft guidanceFDA draft guidance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

In MemoriumIn Memorium

Harry A. Guess, M.D.,Ph.D.Harry A. Guess, M.D.,Ph.D.

I