Analyzing multiple endpoints in clinical trials of pain treatments: IMMPACT recommendations

Dennis C. Turk, Robert H. Dworkin, Michael P. McDermott, Nicholas Bellamy, Laurie B. Burke, Julie M. Chandler, Charles S. Cleeland, Penney Cowan, Rozalina Dimitrova, John T. Farrar, Sharon Hertz, Joseph F. Heyse, Smriti Iyengar, Alejandro R. Jadad, Gary W. Jay, John A. Jermano, Nathaniel P. Katz, Donald C. Manning, Susan Martin, Mitchell B. MaxPatrick McGrath, Henry J. McQuay, Steve Quessy, Bob A. Rappaport, Dennis A. Revicki, Margaret Rothman, Joseph W. Stauffer, Ola Svensson, Richard E. White, James Witter

Research output: Contribution to journalReview articlepeer-review

Abstract

The increasing complexity of randomized clinical trials and the practice of obtaining a wide variety of measurements from study participants have made the consideration of multiple endpoints a critically important issue in the design, analysis, and interpretation of clinical trials. Failure to consider important outcomes can limit the validity and utility of clinical trials; specifying multiple endpoints for the evaluation of treatment efficacy, however, can increase the rate of false positive conclusions about the efficacy of a treatment. We describe the use of multiple endpoints in the design, analysis, and interpretation of pain clinical trials, and review available strategies and methods for addressing multiplicity. To decrease the probability of a Type I error (i.e., the likelihood of obtaining statistically significant results by chance) in pain clinical trials, the use of gatekeeping procedures and other methods that correct for multiple analyses is recommended when a single primary endpoint does not adequately reflect the overall benefits of treatment. We emphasize the importance of specifying in advance the outcomes and clinical decision rule that will serve as the basis for determining that a treatment is efficacious and the methods that will be used to control the overall Type I error rate.

Original languageEnglish (US)
Pages (from-to)485-493
Number of pages9
JournalPain
Volume139
Issue number3
DOIs
StatePublished - Oct 31 2008

Keywords

  • Acute pain
  • Chronic pain
  • Clinical trials
  • Multiple endpoints
  • Multiplicity
  • Sampling error
  • Treatment outcomes
  • Type I error

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology
  • Anesthesiology and Pain Medicine

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