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