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Use of Patient-Reported Outcomes in Phase III Cancer Treatment Trials: Lessons Learned and Future Directions

Patricia A. Ganz, Carolyn C. Gotay

From the University of California, Los Angeles Schools of Medicine and Public Health, Division of Cancer Prevention and Control Research, Jonsson Comprehensive Cancer Center, Los Angeles, CA; and Cancer Research Center of Hawaii, Honolulu, HI

Address reprint requests to Patricia A. Ganz, MD, Division of Cancer Prevention and Control Research, Jonsson Comprehensive Cancer Center, 650 Charles Young Dr South, Rm A2-125 CHS, Los Angeles, CA 90095-6900; e-mail: pganz{at}ucla.edu

Purpose: This article examines the challenges, opportunities, and successes that have occurred in the incorporation of patient-reported outcomes (PROs) in phase III cancer clinical trials.

Methods: An informal survey of the leadership of US cooperative group PRO investigators identified diverse trials in which PROs had been measured. Exemplary trials were selected for lessons learned and for examination of successful strategies.

Results: We review four challenging trials in depth, illustrating some of the difficulties in integrating PROs within treatment trials, including issues related to missing data, lack of procedures for monitoring patients and ensuring collection of PRO data, and missed opportunities in publication of treatment and PRO outcomes together. Four examples of successful trials are highlighted.

Conclusion: As a result of this review, the authors make specific recommendations related to the use of PROs in phase III trials, focusing on issues related to design, choice of PRO instrument and frequency of administration, analysis, and publication strategies.

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

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