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Issues and Challenges With Integrating Patient-Reported Outcomes in Clinical Trials Supported by the National Cancer Institute–Sponsored Clinical Trials Networks

Deborah Watkins Bruner, Charlene J. Bryan, Neil Aaronson, C. Craig Blackmore, Michael Brundage, David Cella, Patricia A. Ganz, Carolyn Gotay, Pamela S. Hinds, Alice B. Kornblith, Benjamin Movsas, Jeff Sloan, Lari Wenzel, Giles Whalen

From the Radiation Therapy Oncology Group; University of Pennsylvania, School of Nursing; American College of Radiology Imaging Network; Eastern Cooperative Oncology Group; Gynecologic Oncology Group, Philadelphia; National Adjuvant Breast and Bowel Project, Pittsburgh, PA; European Organisation for Research and Treatment of Cancer, Brussels, Belgium; National Cancer Institute of Canada, Kingston, Ontario, Canada; Southwest Oncology Group, Ann Arbor, MI; Chilren's Oncology Group, Arcadia, CA; Cancer and Leukemia Group B, Chicago, IL; North Central Clinical Trials Group, Rochester, MN; and American College of Surgeons Oncology Group, Durham, NC

Address reprint requests to Deborah Watkins Bruner, RN, PhD, University of Pennsylvania, School of Nursing, 420 Guardian Dr, Philadelphia, PA 19104-6096; e-mail: wbruner{at}nursing.upenn.edu

Purpose: The objective of this report is to provide a historical overview of and the issues and challenges inherent in the incorporation of patient-reported outcomes (PROs) into multinational cancer clinical trials in the cancer cooperative groups.

Methods: An online survey of 12 cancer cooperative groups from the United States, Canada, and Europe was conducted between June and August of 2006. Each of the cooperative groups designated one respondent, who was a member of one of the PRO committees within the cooperative group.

Results: There was a 100% response rate, and all of the cancer clinical trial cooperative groups reported conducting PRO research. PRO research has been conducted in the cancer cooperative groups for an average of 15 years (range, 6 to 30 years), and all groups had multidisciplinary committees focused on the design of PRO end points and the choice of appropriate PRO measures for cancer clinical trials. The cooperative groups reported that 5% to 50% of cancer treatment trials and an estimated 50% to 75% of cancer control trials contained PRO primary and secondary end points. There was considerable heterogeneity among the cooperative groups with respect to the formal and informal policies and procedures or cooperative group culture towards PROs, investigator training/mentorship, and resource availability for the measurement and conduct of PRO research within the individual cooperatives.

Conclusion: The challenges faced by the cooperative groups to the incorporation of PROs into cancer clinical trials are varied. Some common opportunities for improvement include the adoption of standardized training/mentorship mechanisms for investigators for the conduct of PRO assessments and data collection and the development of minimal criteria for PRO measure acceptability. A positive cultural shift has occurred in most of the cooperative groups related to the incorporation of PROs in clinical trials; however, financial and other resource barriers remain and need to be addressed.

Presented in part at the Patient-Reported Outcomes Assessment in Cancer Trials: Evaluating and Enhancing the Payoff to Decision Making Conference, September 20-21, 2006, Bethesda, MD.

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

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