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

Dworkin, Robert H., Turk, Dennis C., Peirce-Sandner, Sarah, Burke, Laurie B., Farrar, John T., Gilron, Ian, Jensen, Mark P., Katz, Nathaniel P., Raja, Srinivasa N., Rappaport, Bob A., Rowbotham, Michael C., Backonja, Misha-Miroslav, Baron, Ralf, Bellamy, Nicholas, Bhagwagar, Zubin, Costello, Ann, Cowan, Penney, Fang, Weikai, Hertz, Sharon, Jay, Gary W., Junor, Roderick, Kerns, Robert D., Kerwin, Rosemary, Kopecky, Ernest A., Lissin, Dmitri, Malamut, Richard, Markman, John D., McDermott, Michael P., Munera, Catherine, Porter, Linda, Rauschkolb, Christine, Rice, Andrew S. C., Sampaio, Cristina, Skljarevski, Vladimir, Sommerville, Kenneth, Stacey, Brett R., Steigerwald, Ilona, Tobias, Jeffrey, Trentacosti, Ann Marie, Wasan, Ajay D., Wells, George A., Williams, Jim, Witter, James and Ziegler, Dan (2012) Considerations for improving assay sensitivity in chronic pain clinical trials: IMMPACT recommendations. Pain, 153 6: 1148-1158. doi:10.1016/j.pain.2012.03.003

Author Dworkin, Robert H.
Turk, Dennis C.
Peirce-Sandner, Sarah
Burke, Laurie B.
Farrar, John T.
Gilron, Ian
Jensen, Mark P.
Katz, Nathaniel P.
Raja, Srinivasa N.
Rappaport, Bob A.
Rowbotham, Michael C.
Backonja, Misha-Miroslav
Baron, Ralf
Bellamy, Nicholas
Bhagwagar, Zubin
Costello, Ann
Cowan, Penney
Fang, Weikai
Hertz, Sharon
Jay, Gary W.
Junor, Roderick
Kerns, Robert D.
Kerwin, Rosemary
Kopecky, Ernest A.
Lissin, Dmitri
Malamut, Richard
Markman, John D.
McDermott, Michael P.
Munera, Catherine
Porter, Linda
Rauschkolb, Christine
Rice, Andrew S. C.
Sampaio, Cristina
Skljarevski, Vladimir
Sommerville, Kenneth
Stacey, Brett R.
Steigerwald, Ilona
Tobias, Jeffrey
Trentacosti, Ann Marie
Wasan, Ajay D.
Wells, George A.
Williams, Jim
Witter, James
Ziegler, Dan
Title Considerations for improving assay sensitivity in chronic pain clinical trials: IMMPACT recommendations
Journal name Pain   Check publisher's open access policy
ISSN 0304-3959
Publication date 2012-06
Sub-type Critical review of research, literature review, critical commentary
DOI 10.1016/j.pain.2012.03.003
Volume 153
Issue 6
Start page 1148
End page 1158
Total pages 11
Place of publication Amsterdam, Netherlands
Publisher Elsevier
Collection year 2013
Language eng
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.
Keyword Concentration capsaicin patch
Randomized controlled trials
Placebo controlled trials
Peripheral neuropathic pain
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Critical review of research, literature review, critical commentary
Collections: Official 2013 Collection
School of Medicine Publications
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Citation counts: TR Web of Science Citation Count  Cited 92 times in Thomson Reuters Web of Science Article | Citations
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Created: Fri, 22 Jun 2012, 10:14:59 EST by Chesne McGrath on behalf of National Research on Disability and Rehabilitation Medicine