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

被引：232

作者：

Dworkin, Robert H. ^{[1
,2
,3
]}

Turk, Dennis C. ^{[4
]}

Peirce-Sandner, Sarah

Burke, Laurie B. ^{[5
]}

Farrar, John T. ^{[6
]}

Gilron, Ian ^{[7
]}

Jensen, Mark P. ^{[4
]}

Katz, Nathaniel P. ^{[8
,9
]}

Raja, Srinivasa N. ^{[10
]}

Rappaport, Bob A. ^{[5
]}

Rowbotham, Michael C. ^{[11
]}

Backonja, Misha-Miroslav ^{[12
]}

Baron, Ralf ^{[13
]}

Bellamy, Nicholas ^{[14
]}

Bhagwagar, Zubin ^{[15
]}

Costello, Ann ^{[5
]}

Cowan, Penney ^{[16
]}

Fang, Weikai Christopher ^{[17
]}

Hertz, Sharon ^{[5
]}

Jay, Gary W. ^{[18
]}

Junor, Roderick ^{[19
]}

Kerns, Robert D. ^{[20
,21
]}

Kerwin, Rosemary ^{[22
]}

Kopecky, Ernest A. ^{[23
]}

Lissin, Dmitri ^{[24
]}

Malamut, Richard ^{[25
]}

Markman, John D.

McDermott, Michael P.

Munera, Catherine ^{[26
]}

Porter, Linda ^{[27
]}

Rauschkolb, Christine ^{[28
]}

Rice, Andrew S. C. ^{[29
]}

Sampaio, Cristina ^{[30
]}

Skljarevski, Vladimir ^{[31
]}

Sommerville, Kenneth ^{[32
]}

Stacey, Brett R. ^{[33
]}

Steigerwald, Ilona ^{[34
]}

Tobias, Jeffrey ^{[35
]}

Trentacosti, Ann Marie ^{[5
]}

Wasan, Ajay D. ^{[36
]}

Wells, George A. ^{[37
]}

Williams, Jim ^{[38
]}

Witter, James ^{[25
]}

Ziegler, Dan ^{[39
]}

机构：

[1] Univ Rochester, Med Ctr, Dept Anesthesiol, Rochester, NY 14642 USA

[2] Univ Rochester, Dept Neurol, Rochester, NY 14642 USA

[3] Univ Rochester, Ctr Human Expt Therapeut, Rochester, NY 14642 USA

[4] Univ Washington, Seattle, WA 98195 USA

[5] US FDA, Silver Spring, MD USA

[6] Univ Penn, Philadelphia, PA 19104 USA

[7] Queens Univ, Kingston, ON, Canada

[8] Analges Solut, Natick, MA USA

[9] Tufts Univ, Boston, MA 02111 USA

[10] Johns Hopkins Univ, Baltimore, MD USA

[11] Calif Pacific Med Ctr, Res Inst, San Francisco, CA USA

[12] Univ Wisconsin, Madison, WI USA

[13] Univ Kiel, Kiel, Germany

[14] Univ Queensland, Brisbane, Qld, Australia

[15] Bristol Myers Squibb Co, Wallingford, CT 06492 USA

[16] Amer Chron Pain Assoc, Rocklin, CA USA

[17] DePuy Spine, Raynham, MA USA

[18] Pfizer, New London, CT USA

[19] Eisai Ltd, Hatfield, Herts, England

[20] Dept Vet Affairs, West Haven, CT USA

[21] Yale Univ, New Haven, CT USA

[22] Nuvo Res, W Chester, PA USA

[23] Endo Pharmaceut Inc, Chadds Ford, PA USA

[24] Durect Corp, Cupertino, CA USA

[25] AstraZeneca, Wilmington, DE USA

[26] Purdue Pharma, Stamford, CT USA

[27] NIH, Bethesda, MD 20892 USA

[28] Johnson & Johnson Pharmaceut Res & Dev, Titusville, NJ USA

[29] Univ London Imperial Coll Sci Technol & Med, London, England

[30] Fac Med Lisbon, Lisbon, Portugal

[31] Eli Lilly & Co, Indianapolis, IN 46285 USA

[32] King Pharmaceut, Cary, NC USA

[33] Oregon Hlth & Sci Univ, Portland, OR 97201 USA

[34] Grunenthal GmbH, Aachen, Germany

[35] NeurogesX Inc, San Carlos, CA USA

[36] Harvard Univ, Sch Med, Boston, MA USA

[37] Univ Ottawa, Ottawa, ON, Canada

[38] Smith & Nephew, Durham, NC USA

[39] Univ Dusseldorf, German Diabet Ctr, D-40225 Dusseldorf, Germany

来源：

PAIN | 2012年 / 153卷 / 06期

基金：

美国国家卫生研究院;

关键词：

CONCENTRATION CAPSAICIN PATCH; RANDOMIZED CONTROLLED-TRIALS; PLACEBO-CONTROLLED TRIALS; PERIPHERAL NEUROPATHIC PAIN; LONG-TERM TRIALS; LEAD-IN PERIOD; LOW-BACK-PAIN; DOUBLE-BLIND; POSTHERPETIC NEURALGIA; ENRICHED ENROLLMENT;

D O I：

10.1016/j.pain.2012.03.003

中图分类号：

R614 [麻醉学];

学科分类号：

100217 ;

摘要：

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. (C) 2012 International Association for the Study of Pain. Published by Elsevier B. V. All rights reserved.

引用

页码：1148 / 1158

页数：11

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