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Funding Patient-Reported Outcomes in Cancer Clinical Trials

Carol M. Moinpour, Andrea M. Denicoff, Deborah Watkins Bruner, Alice B. Kornblith, Stephanie R. Land, Ann O'Mara, Edward Trimble

From the Southwest Oncology Group Statistical Center/Fred Hutchinson Cancer Research Center, Seattle, WA; Clinical Investigations Branch, Cancer Therapy Evaluation Program, and Community Clinical Oncology Program, National Cancer Institute, National Institutes of Health, Bethesda, MD; Radiation Therapy Oncology Group/University of Pennsylvania, Philadelphia; National Surgical Adjuvant Breast and Bowel Program Biostatistical Center and Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA; and Cancer and Leukemia Group B/Dana-Farber Cancer Center, Boston, MA

Address reprint requests to Carol M. Moinpour, PhD, Southwest Oncology Group Statistical Center, Fred Hutchinson Cancer Research Center/M3-C102, 1100 Fairview Ave North, Box 19024, Seattle, WA 98104-1024; e-mail: cmoinpou{at}fhcrc.org

We surveyed four cooperative groups to identify current funding sources for the collection and analysis effort associated with the inclusion of patient-reported outcome (PRO) data in cancer clinical trials. Survey questions included what proportion of staff effort was funded through the Cancer Therapy Evaluation Program (CTEP) and the Community Clinical Oncology Program (CCOP) grants. In addition, the groups were asked to what extent outside funding was solicited to cover an underfunded PRO effort (eg, the pharmaceutical industry, foundations, or National Institutes of Health grants). All four groups noted the challenge of making limited resources cover a number of trial responsibilities. PRO effort is usually bundled with effort required for all clinical trial data. There is variation in the use of the CTEP and CCOP grants to fund PRO research. The groups differed with respect to both the types and amount of outside funding used. This survey focused on funding sources for the conduct of PRO research in cooperative group trials; it did not assess the specific cost components associated with collecting and analyzing these data. In general, the costs for conducting PRO research have been bundled with other study costs because in most cases, the PRO has been considered an integral component of the trial. However, these data also suggest that PRO research has required the use of outside funding sources in the four surveyed cooperative groups and that PRO economic issues require attention if we are to continue the inclusion of these outcomes in cancer clinical trials.

Supported in part by Grants No. RTOG CA37422, CA21661, CA32115; SWOG CA38926 and CA37429; CALBG CA31946; and NSABP CA069974 and CA069974.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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