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 Dueck

Research output: Contribution to journalArticle

73 Citations (Scopus)

Abstract

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scientific field of PROs is evolving, as evidenced by the US Food and Drug Administration's February 2007 release of a draft guidance for using PROs in effectiveness claims for drug labeling.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.

Original languageEnglish (US)
Pages (from-to)5070-5077
Number of pages8
JournalJournal of Clinical Oncology
Volume25
Issue number32
DOIs
StatePublished - Nov 10 2007

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National Cancer Institute (U.S.)
Clinical Trials
Neoplasms
Drug Labeling
Research
United States Food and Drug Administration
Patient Reported Outcome Measures

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Integrating patient-reported outcomes into cancer symptom management clinical trials supported by the National Cancer Institute-sponsored clinical trials networks. / Sloan, Jeff A; Berk, Lawrence; Roscoe, Joseph; Fisch, Michael J.; Shaw, Edward G.; Wyatt, Gwen; Morrow, Gary R.; Dueck, Amylou.

In: Journal of Clinical Oncology, Vol. 25, No. 32, 10.11.2007, p. 5070-5077.

Research output: Contribution to journalArticle

Sloan, Jeff A ; Berk, Lawrence ; Roscoe, Joseph ; Fisch, Michael J. ; Shaw, Edward G. ; Wyatt, Gwen ; Morrow, Gary R. ; Dueck, Amylou. / Integrating patient-reported outcomes into cancer symptom management clinical trials supported by the National Cancer Institute-sponsored clinical trials networks. In: Journal of Clinical Oncology. 2007 ; Vol. 25, No. 32. pp. 5070-5077.
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