Considerations for improving assay sensitivity in chronic pain clinical trials: IMMPACT recommendations

Robert H. Dworkin, Dennis C. Turk, Sarah Peirce-Sandner, Laurie B. Burke, John T. Farrar, Ian Gilron, Mark P. Jensen, Nathaniel P. Katz, Srinivasa N. Raja, Bob A. Rappaport, Michael C. Rowbotham, Misha Miroslav Backonja, Ralf Baron, Nicholas Bellamy, Zubin Bhagwagar, Ann Costello, Penney Cowan, Weikai Christopher Fang, Sharon Hertz, Gary W. JayRoderick Junor, Robert D. Kerns, Rosemary Kerwin, Ernest A. Kopecky, Dmitri Lissin, Richard Malamut, John D. Markman, Michael P. McDermott, Catherine Munera, Linda Porter, Christine Rauschkolb, Andrew S.C. Rice, Cristina Sampaio, Vladimir Skljarevski, Kenneth Sommerville, Brett R. Stacey, Ilona Steigerwald, Jeffrey Tobias, Ann Marie Trentacosti, Ajay D. Wasan, George A. Wells, Jim Williams, James Witter, Dan Ziegler

Research output: Contribution to journalReview article

163 Scopus citations

Abstract

A number of pharmacologic treatments examined in recent randomized clinical trials (RCTs) have failed to show statistically significant superiority to placebo in conditions in which their efficacy had previously been demonstrated. Assuming the validity of previous evidence of efficacy and the comparability of the patients and outcome measures in these studies, such results may be a consequence of limitations in the ability of these RCTs to demonstrate the benefits of efficacious analgesic treatments vs placebo ("assay sensitivity"). Efforts to improve the assay sensitivity of analgesic trials could reduce the rate of falsely negative trials of efficacious medications and improve the efficiency of analgesic drug development. Therefore, an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials consensus meeting was convened in which the assay sensitivity of chronic pain trials was reviewed and discussed. On the basis of this meeting and subsequent discussions, the authors recommend consideration of a number of patient, study design, study site, and outcome measurement factors that have the potential to affect the assay sensitivity of RCTs of chronic pain treatments. Increased attention to and research on methodological aspects of clinical trials and their relationships with assay sensitivity have the potential to provide the foundation for an evidence-based approach to the design of analgesic clinical trials and expedite the identification of analgesic treatments with improved efficacy and safety.

Original languageEnglish (US)
Pages (from-to)1148-1158
Number of pages11
JournalPain
Volume153
Issue number6
DOIs
StatePublished - Jun 2012

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology
  • Anesthesiology and Pain Medicine

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    Dworkin, R. H., Turk, D. C., Peirce-Sandner, S., Burke, L. B., Farrar, J. T., Gilron, I., Jensen, M. P., Katz, N. P., Raja, S. N., Rappaport, B. A., Rowbotham, M. C., Backonja, M. M., Baron, R., Bellamy, N., Bhagwagar, Z., Costello, A., Cowan, P., Fang, W. C., Hertz, S., ... Ziegler, D. (2012). Considerations for improving assay sensitivity in chronic pain clinical trials: IMMPACT recommendations. Pain, 153(6), 1148-1158. https://doi.org/10.1016/j.pain.2012.03.003