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PROACT Agenda

National Cancer Institute
National Institutes of Health
Department of Health and Human Services

Patient-Reported Outcomes Assessment in Cancer Trials:
Evaluating and Enhancing the Payoff to Decision Making

Marriott Bethesda North Hotel and Conference Center
September 20-21, 2006

Agenda

Wednesday, September 20, 2006

8:30 a.m. – 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 a.m. – 9:15 a.m.

Patient-Reported Outcomes Assessment in Clinical Trials: Overview and Charge

Rachel Ballard-Barbash, M.D., M.P.H.
Associate Director
Applied Research Program
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 a.m. – 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 a.m. – 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 p.m. – 1:30 p.m. Lunch
1:30 p.m. – 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 p.m. – 3:30 p.m. Break
3:30 p.m. – 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.
Vice Chair
Radiation Therapy Oncology Group (Cancer Control)
Associate Professor and Medical Director of Radiation Oncology Moffitt Clinic at Tampa General Hospital
H Lee Moffitt Cancer Center
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 p.m. – 6:00 p.m.

Poster Session/Reception

  • Poster Session Theme: Enhancing Patient-Reported Outcomes in Cancer Trials
6:00 p.m.

Adjournment



Thursday, September 21, 2006

8:00 a.m. – 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 a.m. – 9:45 a.m. Break
9:45 a.m. – 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 p.m. – 1:15 p.m.

Lunch

1:15 p.m. – 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 p.m. – 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]
Quality of Life Science Advisory Committee
American Cancer Society
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 p.m. – 3:30 p.m.

Wrap-Up and Adjournment

Last Modified: 11 Apr 2014