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Tentative Agenda
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Wednesday, September 20, 2006
8:30 – 8:45 a.m. Opening/Introductions

Steven B. Clauser, Ph.D.
Chief
Outcomes Research Branch
Division of Cancer Control and Population Sciences
National Cancer Institute
8:45 – 9:15 a.m. Patient-Reported Outcomes Assessment in Clinical Trials: Overview and Charge

Robert T. Croyle, Ph.D.
Director
Division of Cancer Control and Population Sciences
National Cancer Institute

Peter Greenwald, M.D., Dr.PH.
Director
Division of Cancer Prevention
National Cancer Institute
9:15 – 10:00 a.m. Issues and Challenges With Integrating Patient-Reported Outcomes in Clinical Trials Supported by National Cancer Institute-Sponsored Clinical Trials Networks

Maria Sgambati, M.D. [Chair]
Program Director
Community Oncology and Prevention Trials Research Group
Division of Cancer Prevention
National Cancer Institute

Deborah Watkins Bruner, R.N., Ph.D.
Professor
School of Nursing
University of Pennsylvania
   
10:00 – 10:15 a.m. Break
   
10:15 a.m. – 12:15 p.m. Patient-Reported Outcomes Assessment in Phase III Cancer Treatment Trials: Part I
  • A Case Study Analysis of Issues and Challenges for Integrating Patient-Reported Outcomes in Phase III Cancer Clinical Trials
Jeffrey S. Abrams, M.D. [Chair]
Chief
Clinical Investigations Branch
Division of Cancer Treatment and Diagnosis
National Cancer Institute

Patricia A. Ganz, M.D.
Professor
University of California at Los Angeles Schools of Medicine and Public Health
Division of Cancer Prevention and Control Research
Jonsson Comprehensive Cancer Center

Carolyn C. Gotay, Ph.D.
Professor
Cancer Research Center of Hawaii
University of Hawaii
  • Question and Answer Session
   
12:15 – 1:30 p.m. Lunch
   
1:30 – 2:45 p.m. Patient-Reported Outcomes Assessment in Phase III Cancer Treatment Trials: Part II

Jeffrey S. Abrams, M.D. [Chair]
Chief
Clinical Investigations Branch
Division of Cancer Treatment and Diagnosis
National Cancer Institute
  • Lessons for Trial Sponsors and Investigators
Carolyn C. Gotay, Ph.D.
Professor
Cancer Research Center of Hawaii
University of Hawaii

Patricia A. Ganz, M.D.
Professor
University of California at Los Angeles Schools of Medicine and Public Health
Division of Cancer Prevention and Control Research
Jonsson Comprehensive Cancer Center
  • Round Table Discussion/Reactions
Discussants:

David Cella, Ph.D.
Professor
Psychiatry and Behavioral Sciences, and Institute for Healthcare Studies, Feinberg School of Medicine, Northwestern University
Director
Center on Outcomes, Research and Education (CORE)
Evanston Northwestern Healthcare

Pamela J. Goodwin, M.D., M.Sc., F.R.C.P.C.
Senior Scientist
Samuel Lunenfeld Research Institute Marvelle Koffler Chair in Breast Cancer Research
Professor of Medicine
University of Toronto
Mount Sinai Hospital

James Hayman, M.D.
Associate Professor and Director
Clinical Division
Department of Radiation Oncology
University of Michigan
  • Question and Answer Session
   
2:45 p.m. – 3:15 p.m. Funding Patient-Reported Outcomes Assessment in Cancer Clinical Trials

Andrea Denicoff, R.N., M.S., A.N.P. [Chair]
Nurse Consultant and Coordinator of Palliative Care Initiatives
Clinical Investigations Branch
Division of Cancer Treatment and Diagnosis
National Cancer Institute

Carol M. Moinpour, Ph.D.
Behavioral Scientist
Southwest Oncology Group Statistical Center
Associate Member
Division of Public Health Sciences
Fred Hutchinson Cancer Research Center
  • Question and Answer Session
   
3:15 – 3:30 p.m. Break
   
3:30 – 5:00 p.m. Patient-Reported Outcomes Assessment in Cancer Symptom Management Trials

Ann O’Mara, Ph.D., R.N. [Chair]
Program Director
Community Clinical Oncology Program
Division of Cancer Prevention
National Cancer Institute

Jeff A. Sloan, Ph.D.
Professor of Oncology and Health Services Research
Mayo Clinic College of Medicine
Mayo Clinic – Division of Biostatistics

Lawrence Berk, M.D., Ph.D.
Associate Professor
Clinical Director of Radiation Oncology
Moffitt Cancer Center and the University of South Florida

Joseph A. Roscoe, Ph.D.
Research Associate Professor
Department of Radiation Oncology
Behavioral Medicine Unit
University of Rochester Cancer Center

Michael J. Fisch, M.D., M.P.H. [Discussant]
Medical Director
M.D. Anderson Cancer Center Community Clinical Oncology Program Research Base Chair
Eastern Cooperative Oncology Group Symptom Management Committee
Associate Professor
General Oncology and Palliative Care
The University of Texas M.D. Anderson Cancer Center
  • Question and Answer Session
5:00 – 6:00 p.m. Poster Session / Reception

  • Poster Session Theme: Enhancing Patient-Reported Outcomes in Cancer Trials
  •    
    6:00 p.m. Adjourn
       
    Thursday, September 21, 2006
    8:00 – 9:30 a.m. Phase I and Phase II Cancer Clinical Trials: What Can Patient-Reported Outcomes Do for You?

    Lynne I. Wagner, Ph.D. [Chair]
    Clinical Research Scientist
    Assistant Professor
    Institute for Health Services Research and Policy Studies
    Northwestern University

    Lari Wenzel, Ph.D.
    Associate Professor
    General Internal Medicine
    University of California, Irvine

    Edward G. Shaw, M.D.
    Professor and Chairman
    Department of Radiation Oncology
    Wake Forest University School of Medicine
    Director
    Clinical Research Program Comprehensive Cancer Center of Wake Forest University

    David Cella, Ph.D. [Discussant]
    Professor
    Psychiatry and Behavioral Sciences, and Institute for Healthcare Studies
    Feinberg School of Medicine, Northwestern University
    Director
    Center on Outcomes, Research and Education (CORE)
    Evanston Northwestern Healthcare
    • Question and Answer Session
       
    9:30 – 9:45 a.m. Break
       
    9:45 – 10:50 a.m. International Perspectives on Issues and Challenges To Integrating Patient-Reported Outcomes in Cancer Trials

    Bryce B. Reeve, Ph.D. [Chair]
    Program Director
    Outcomes Research Branch
    Division of Cancer Control and Population Sciences
    National Cancer Institute

    Michael D. Brundage, M.Sc., F.R.C.P.C., M.D.
    Professor of Oncology and Community Health and Epidemiology
    Medical Director, Radiation Oncology
    Queen’s University Cancer Research Institute

    Neil K. Aaronson, Ph.D.
    Head
    Division of Psychosocial Research and Epidemiology
    The Netherlands Cancer Institute
    Chairman
    Quality of Life Group
    European Organization for Research and Treatment of Cancer

    Andrew Bottomley, Ph.D.
    Head
    Quality of Life Unit
    European Organization for Research and Treatment of Cancer, Belgium
    • Question and Answer Session
       
    10:50 a.m. – 12:15 p.m. Industry and U.S. Food and Drug Administration Perspectives on Patient-Reported Outcomes in Cancer Trials

    Dennis Revicki, Ph.D. [Chair]
    Senior Vice President and Director
    Center for Health Outcomes Research
    United BioSource Corporation

    Kathleen Gondek, Ph.D.
    Head
    Global Health Economics and Outcomes Research
    Therapeutic Areas, North America
    Bayer Pharmaceuticals

    Laurie B. Burke, R.Ph., M.P.H.
    Director
    Study Endpoints and Label Development Team
    Office of New Drugs
    Center for Drug Evaluation and Research
    U.S. Food and Drug Administration

    Edwin P. Rock, M.D., Ph.D.
    Medical Officer
    Division of Oncology Drug Products
    Center for Drug Evaluation and Research
    U.S. Food and Drug Administration
    • Question and Answer Session
       
    12:15 – 1:15 p.m. Lunch
       
    1:15 – 1:35 p.m. National Cancer Institute’s Clinical Trials Working Group and Its Implementation Process

    Edward Trimble, M.D., M.P.H. [Chair]
    Head
    Gynecologic Cancer Therapeutics and Quality of Cancer Care Therapeutics
    Clinical Investigations Branch
    Cancer Therapy Evaluation Program
    Division of Cancer Treatment and Diagnosis
    National Cancer Institute

    James H. Doroshow, M.D.
    Director
    Division of Cancer Treatment and Diagnosis
    Chairman
    Clinical Trials Working Group
    National Cancer Institute
       
    1:35 – 3:20 p.m. Enhancing Patient-Reported Outcomes Assessment in Cancer Trials

    A panel of experts will discuss issues related to these broad themes:
    • Identifying when, where, and how Patient Reported Outcomes (PRO) assessment is likely to add significant value to the findings from a cancer trial and therefore should be recommended.
    • Developing guidance for the cost-effective conduct of PRO assessment in trials to maximize the useful information obtained while holding respondent and administrative burdens to acceptable levels.
    • Specifying how the research agenda in cancer outcomes measurement and evaluation can best inform decisionmaking on the use of PROs in cancer trials.
    Panel Members:

    Neil K. Aaronson, Ph.D.
    Head
    Division of Psychosocial Research and Epidemiology
    The Netherlands Cancer Institute
    Chairman
    Quality of Life Group
    European Organization for Research and Treatment of Cancer

    Jan C. Buckner, M.D.
    Professor of Oncology
    Mayo Clinic College of Medicine
    Chair
    North Central Cancer Treatment Group
    Chair
    Mayo Clinic Cancer Research Consortium

    Susan L. Butler
    Ovarian Cancer National Alliance
    Ovarian Cancer Coalition of Greater Washington

    Patricia A. Ganz, M.D.
    Professor
    University of California at Los Angeles Schools of Medicine and Public Health
    Division of Cancer Prevention and Control Research
    Jonsson Comprehensive Cancer Center

    Kathleen Gondek, Ph.D.
    Head
    Global Health Economics and Outcomes Research
    Therapeutic Areas, North America
    Bayer Pharmaceuticals

    Pamela S. Hinds, Ph.D., R.N., F.A.A.N.
    Director
    Division of Nursing Research
    St. Jude Children’s Research Hospital

    Paula Kim
    President and Founder
    TRAC-Translating Research Across Communities

    Joseph Lipscomb, Ph.D. [Moderator]
    Professor
    Health Policy and Management
    Georgia Cancer Coalition Distinguished Cancer Scholar
    Rollins School of Public Health
    Emory University

    Lori Minasian, M.D., F.A.C.P.
    Chief
    Community Oncology and Prevention Trials Research Group
    Division of Cancer Prevention
    National Cancer Institute


    Edwin P. Rock, M.D., Ph.D.
    Medical Officer
    Division of Oncology Drug Products
    Center for Drug Evaluation and Research
    U.S. Food and Drug Administration

    Julia Rowland, Ph.D.
    Director
    Office of Cancer Survivorship
    Division of Cancer Control and Population Sciences
    National Cancer Institute

    Edward Trimble, M.D., M.P.H.
    Head
    Gynecologic Cancer Therapeutics and Quality of Cancer Care Therapeutics
    Clinical Investigations Branch
    Cancer Therapy Evaluation Program
    Division of Cancer Treatment and Diagnosis
    National Cancer Institute
       
    3:20 – 3:30 p.m. Wrap-up and Adjournment



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