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

The National Cancer Institute (NCI) and the American Cancer Society (ACS)External Web Site Policy co-sponsored the PROACT conference on September 20 - 21, 2006, to determine what we know about the use and value of health-related quality of life (HRQOL) in trials, identify the challenges to more frequent or extensive application, and identify the research studies and application projects that would enhance the decision-relevance of HRQOL measurement in trials. Members of the conference scientific program committee (SPC) included experts in health outcomes, behavioral science and psychometrics from academia, industry, and government.

Specific goals were to:

  • Examine when, where, and how the measurement of patient-reported outcomes (PROs), such as HRQOL, in cancer trials can yield valuable information for decisions about cancer care, third-party reimbursement, and drug approval.
  • Identify "best practices" for the application of PRO measures in a range of cancer clinical trials (treatment and symptom management) through a critical examination of case studies developed expressly for the conference.
  • Serve as a platform for informing the NCI Clinical Trials Working Group implementation process to ensure that the most important quality-of-life studies can be initiated in a timely manner in association with NCI-sponsored clinical trials.
  • Inform the research agenda on improving the application of PRO measures in clinical trials generally.

A comprehensive summary of the discussions and recommendations from the PROACT conference have been published in the Journal of Clinical Oncology (Vol. 25, No. 32).

The meeting agenda and speakers' presentations are available.

Scientific Program Committee Members

  • Jeffrey S. Abrams, M.D. (National Cancer Institute)
  • Deborah Watkins Bruner, Ph.D., R.N. (University of Pennsylvania)
  • Laurie B. Burke, R.Ph., M.P.H. (Food and Drug Administration)
  • Steven B. Clauser, Ph.D. (National Cancer Institute)
  • Andrea Denicoff, M.S., R.N., A.N.P. (National Cancer Institute)
  • Patricia A. Ganz, M.D. (University of California - Los Angeles)
  • Kathleen Gondek, Ph.D. (Bayer Pharmaceuticals)
  • Joseph Lipscomb, Ph.D. (Chair) (Emory University)
  • Lori Minasian, M.D., F.A.C.P. (National Cancer Institute)
  • Ann O'Mara, Ph.D., R.N. (National Cancer Institute)
  • Bryce B. Reeve, Ph.D. (National Cancer Institute)
  • Dennis Revicki, Ph.D. (United BioSource Corporation)
  • Edwin P. Rock, M.D., Ph.D. (Food and Drug Administration)
  • Julia Rowland, Ph.D. (National Cancer Institute)
  • Maria Sgambati, M.D. (National Cancer Institute)
  • Edward Trimble, M.D., M.P.H. (National Cancer Institute)

Last Modified: 11 Apr 2014