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) 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)
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