Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations

Robert H. Dworkin, Dennis C. Turk, Sarah Peirce-Sandner, Ralf Baron, Nicholas Bellamy, Laurie B. Burke, Amy Chappell, Kevin Chartier, Charles S. Cleeland, Ann Costello, Penney Cowan, Rozalina Dimitrova, Susan Ellenberg, John T. Farrar, Jacqueline A. French, Ian Gilron, Sharon Hertz, Alejandro R. Jadad, Gary W. Jay, Jarkko KalliomäkiNathaniel P. Katz, Robert D. Kerns, Donald C. Manning, Michael P. McDermott, Patrick J. McGrath, Arvind Narayana, Linda Porter, Steve Quessy, Bob A. Rappaport, Christine Rauschkolb, Bryce B. Reeve, Thomas Rhodes, Cristina Sampaio, David M. Simpson, Joseph W. Stauffer, Gerold Stucki, Jeffrey Tobias, Richard E. White, James Witter

Research output: Contribution to journalReview article

Abstract

There has been an increase in the number of chronic pain clinical trials in which the treatments being evaluated did not differ significantly from placebo in the primary efficacy analyses despite previous research suggesting that efficacy could be expected. These findings could reflect a true lack of efficacy or methodological and other aspects of these trials that compromise the demonstration of efficacy. There is substantial variability among chronic pain clinical trials with respect to important research design considerations, and identifying and addressing any methodological weaknesses would enhance the likelihood of demonstrating the analgesic effects of new interventions. An IMMPACT consensus meeting was therefore convened to identify the critical research design considerations for confirmatory chronic pain trials and to make recommendations for their conduct. We present recommendations for the major components of confirmatory chronic pain clinical trials, including participant selection, trial phases and duration, treatment groups and dosing regimens, and types of trials. Increased attention to and research on the methodological aspects of confirmatory chronic pain clinical trials has the potential to enhance their assay sensitivity and ultimately provide more meaningful evaluations of treatments for chronic pain.

Original languageEnglish (US)
Pages (from-to)177-193
Number of pages17
JournalPain
Volume149
Issue number2
DOIs
StatePublished - May 1 2010

Keywords

  • Chronic pain
  • Phase 3 trials
  • Randomized clinical trials
  • Research design
  • Subject selection

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology
  • Anesthesiology and Pain Medicine

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  • Cite this

    Dworkin, R. H., Turk, D. C., Peirce-Sandner, S., Baron, R., Bellamy, N., Burke, L. B., Chappell, A., Chartier, K., Cleeland, C. S., Costello, A., Cowan, P., Dimitrova, R., Ellenberg, S., Farrar, J. T., French, J. A., Gilron, I., Hertz, S., Jadad, A. R., Jay, G. W., ... Witter, J. (2010). Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations. Pain, 149(2), 177-193. https://doi.org/10.1016/j.pain.2010.02.018