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Patient-Reported Outcomes Assessment in Cancer Trials: Taking Stock, Moving Forward

Joseph Lipscomb, Bryce B. Reeve, Steven B. Clauser, Jeffrey S. Abrams, Deborah Watkins Bruner, Laurie B. Burke, Andrea M. Denicoff, Patricia A. Ganz, Kathleen Gondek, Lori M. Minasian, Ann M. O'Mara, Dennis A. Revicki, Edwin P. Rock, Julia H. Rowland, Maria Sgambati, Edward L. Trimble

From Emory University, Atlanta, GA; National Cancer Institute; United BioSource Corporation, Bethesda; US Food and Drug Administration, Rockville, MD; University of Pennsylvania, Philadelphia, PA; University of California, Los Angeles, Los Angeles, CA; and Bayer Pharmaceuticals, Montville, NJ

Address reprint requests to Joseph Lipscomb, PhD, Emory University, 1518 Clifton Rd NE, Rm 642, Atlanta, GA 30322; e-mail: jlipsco{at}sph.emory.edu

To evaluate and improve the use of cancer trial end points that reflect the patient's own perspective, the National Cancer Institute organized an international conference, Patient-Reported Outcomes Assessment in Cancer Trials (PROACT), in 2006. The 13 preceding articles in this special issue of the Journal were commissioned in preparation for or in response to the PROACT conference, which was cosponsored by the American Cancer Society. Drawing from these articles and also commentary from the conference itself, this concluding report takes stock of what has been learned to date about the successes and challenges in patient-reported outcome (PRO) assessment in phase III, phase II, and symptom management trials in cancer and identifies ways to improve the scientific soundness, feasibility, and policy relevance of PROs in trials. Building on this synthesis of lessons learned, this article discusses specific administrative policies and management procedures to improve PRO data collection, analysis, and dissemination of findings; opportunities afforded by recent methodologic and technologic advances in PRO data collection and analysis to enhance the scientific soundness and cost efficiency of PRO use in trials; and the importance of better understanding the usefulness of PRO data to the full spectrum of cancer decision makers, including patients and families, health providers, public and private payers, regulatory agencies, and standards-setting organizations.

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

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