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Integrating Patient-Reported Outcomes Into Cancer Symptom Management Clinical Trials Supported by the National Cancer Institute–Sponsored Clinical Trials Networks

Jeff A. Sloan, Lawrence Berk, Joseph Roscoe, Michael J. Fisch, Edward G. Shaw, Gwen Wyatt, Gary R. Morrow, Amylou C. Dueck

From the Department of Health Sciences Research, Mayo Clinic and Mayo Foundation, Rochester, MN; H. Lee Mofitt Cancer Center, University of South Florida, Tampa, FL; University of Rochester Cancer Center Research Base, Rochester, NY; The University of Texas M.D. Anderson Cancer Center, Houston, TX; Wake Forest University Community Clinical Oncology Program, Winston-Salem, NC; and College of Nursing, Michigan State University, East Lansing, MI

Address reprint requests to Jeff A. Sloan, PhD, Department of Health Sciences Research, Mayo Clinic, Harwick 8-29, 200 1st St SW, Rochester, MN 55905; e-mail: jsloan{at}mayo.edu

Patient-reported outcomes (PROs) are often the primary end point in symptom management trials. The scientific field of PROs is evolving, as evidenced by the US Food and Drug Administration's February 2007 release of a draft guidance for using PROs in effectiveness claims for drug labeling. This article presents issues encountered during use of PROs in National Cancer Institute–sponsored symptom management trials. Selected trials are presented that exemplify the challenges often seen in symptom management trials, and solutions are described. The examples presented include defining the appropriate end point, selecting and validating assessments, and answering the research questions through statistical analysis and interpretation. Progress has been made in addressing some of the unique challenges of PRO-based symptom management research. Many challenges still remain, but a foundational body of work now exists for more consistent and rigorous application of PROs into symptom management trials. There remains a need for more research in several methodologic aspects of design, analysis, and interpretation of symptom management trials.

Supported by numerous funding instruments of the National Cancer Institute including, but not limited to, all of the Community Oncology Research Base Infrastructure grants.

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

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