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

被引：308

作者：

Dworkin, Robert H. ^{[1
]}

Turk, Dennis C. ^{[2
]}

Peirce-Sandner, Sarah ^{[1
]}

Baron, Ralf ^{[3
]}

Bellamy, Nicholas ^{[4
]}

Burke, Laurie B. ^{[5
]}

Chappell, Amy ^{[6
]}

Chartier, Kevin ^{[7
]}

Cleeland, Charles S. ^{[8
]}

Costello, Ann ^{[5
]}

Cowan, Penney ^{[9
]}

Dimitrova, Rozalina ^{[10
]}

Ellenberg, Susan ^{[11
]}

Farrar, John T. ^{[11
]}

French, Jacqueline A. ^{[11
]}

Gilron, Ian ^{[12
]}

Hertz, Sharon ^{[5
]}

Jadad, Alejandro R. ^{[13
]}

Jay, Gary W. ^{[14
]}

Kalliomaki, Jarkko ^{[15
]}

Katz, Nathaniel P. ^{[16
]}

Kerns, Robert D. ^{[17
]}

Manning, Donald C. ^{[18
]}

McDermott, Michael P. ^{[19
]}

McGrath, Patrick J. ^{[20
,21
]}

Narayana, Arvind ^{[22
]}

Porter, Linda

Quessy, Steve ^{[23
]}

Rappaport, Bob A. ^{[5
]}

Rauschkolb, Christine ^{[24
]}

Reeve, Bryce B. ^{[25
]}

Rhodes, Thomas ^{[26
]}

Sampaio, Cristina ^{[27
]}

Simpson, David M. ^{[28
]}

Stauffer, Joseph W. ^{[29
]}

Stucki, Gerold ^{[30
]}

Tobias, Jeffrey ^{[31
]}

White, Richard E. ^{[32
]}

Witter, James

机构：

[1] Univ Rochester, Sch Med & Dent, Dept Anesthesiol, Rochester, NY 14642 USA

[2] Univ Washington, Seattle, WA 98195 USA

[3] Univ Kiel, Kiel, Germany

[4] Univ Queensland, Brisbane, Qld, Australia

[5] US FDA, Silver Spring, MD USA

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

[7] United BioSource Corp, Newtown, PA USA

[8] Univ Texas Houston, MD Anderson Canc Ctr, Houston, TX 77030 USA

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

[10] Allergan Pharmaceut Inc, Irvine, CA USA

[11] NYU, New York, NY USA

[12] Queens Univ, Kingston, ON, Canada

[13] Univ Toronto, Toronto, ON, Canada

[14] Schwarz Biosci, Res Triangle Pk, NC USA

[15] AstraZeneca, Sodertalje, Sweden

[16] Analges Res, Needham, MA USA

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

[18] Celgene Corp, Warren, NJ USA

[19] Univ Rochester, Rochester, NY USA

[20] Dalhousie Univ, Halifax, NS, Canada

[21] IWK Hlth Ctr, Halifax, NS, Canada

[22] Cephalon Inc, Frazer, PA USA

[23] Qd Consulting LLC, Res Triangle Pk, NC USA

[24] Johnson & Johnson Pharmaceut Res & Dev LLC, Raritan, NJ USA

[25] NCI, NIH, Bethesda, MD 20892 USA

[26] Merck & Co Inc, Blue Bell, PA USA

[27] Fac Med Lisbon, Lisbon, Portugal

[28] Mt Sinai Sch Med, New York, NY USA

[29] Alpharma, Piscataway, NJ USA

[30] Univ Lucerne & Swiss Parapleg Res, Luzern, Switzerland

[31] NeurogesX Inc, San Carlos, CA USA

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

来源：

PAIN | 2010年 / 149卷 / 02期

基金：

美国国家卫生研究院;

关键词：

Chronic pain; Randomized clinical trials; Research design; Phase; 3; trials; Subject selection; PLACEBO-CONTROLLED TRIAL; LOW-BACK-PAIN; OSTEOARTHRITIS-RESEARCH-SOCIETY; DIABETIC PERIPHERAL NEUROPATHY; OXYMORPHONE EXTENDED-RELEASE; MAJOR DEPRESSIVE DISORDER; ACTIVE-CONTROL TRIALS; CORE OUTCOME DOMAINS; DOUBLE-BLIND; RUN-IN;

D O I：

10.1016/j.pain.2010.02.018

中图分类号：

R614 [麻醉学];

学科分类号：

100217 [麻醉学];

摘要：

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. (C) 2010 International Association for the Study of Pain. Published by Elsevier B. V. All rights reserved.

引用

页码：177 / 193

页数：17

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