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

doi:10.1016/j.pain.2010.02.018

Review

. 2010 May;149(2):177-193.

doi: 10.1016/j.pain.2010.02.018. Epub 2010 Mar 6.

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

Affiliations

Affiliation

¹ Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, 14642, USA University of Washington, Seattle, WA, USA University of Kiel, Kiel, Germany University of Queensland, Brisbane, Australia United States Food and Drug Administration, Silver Spring, MD, USA Eli Lilly & Co., Indianapolis, IN, USA United BioSource Corporation, Newtown, PA, USA M.D. Anderson Cancer Center, Houston, TX, USA American Chronic Pain Association, Rocklin, CA, USA Allergan, Inc, Irvine, CA, USA New York University, New York, NY, USA Queen's University, Kingston, Ontario, Canada University of Toronto, Toronto, Canada Schwarz Biosciences, Research Triangle Park, NC, USA AstraZeneca, Södertälje, Sweden Analgesic Research, Needham, MA, USA Department of Veterans Affairs, West Haven, CT, USA Celgene Corporation, Warren, NJ, USA University of Rochester, Rochester, NY, USA IWK Health Centre and Dalhousie University, Halifax, Nova Scotia, Canada Cephalon, Inc., Frazer, PA, USA National Institutes of Health, Bethesda, MD, USA qd consulting, LLC, Research Triangle Park, NC, USA Johnson & Johnson Pharmaceutical Research & Development LLC, Raritan, NJ, USA National Cancer Institute, National Institutes of Health, Bethesda, MD, USA Merck & Company, Blue Bell, PA, USA Faculdade de Medicina de Lisboa, Lisbon, Portugal Mt. Sinai School of Medicine, New York, NY, USA Alpharma, Piscataway, NJ, USA University of Lucerne and Swiss Paraplegic Research, Lucerne, Switzerland NeurogesX, Inc., San Carlos, CA, USA Endo Pharmaceuticals Inc., Chadds Ford, PA, USA.

PMID: 20207481
DOI: 10.1016/j.pain.2010.02.018

Review

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

Robert H Dworkin et al. Pain. 2010 May.

. 2010 May;149(2):177-193.

doi: 10.1016/j.pain.2010.02.018. Epub 2010 Mar 6.

Affiliation

¹ Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, 14642, USA University of Washington, Seattle, WA, USA University of Kiel, Kiel, Germany University of Queensland, Brisbane, Australia United States Food and Drug Administration, Silver Spring, MD, USA Eli Lilly & Co., Indianapolis, IN, USA United BioSource Corporation, Newtown, PA, USA M.D. Anderson Cancer Center, Houston, TX, USA American Chronic Pain Association, Rocklin, CA, USA Allergan, Inc, Irvine, CA, USA New York University, New York, NY, USA Queen's University, Kingston, Ontario, Canada University of Toronto, Toronto, Canada Schwarz Biosciences, Research Triangle Park, NC, USA AstraZeneca, Södertälje, Sweden Analgesic Research, Needham, MA, USA Department of Veterans Affairs, West Haven, CT, USA Celgene Corporation, Warren, NJ, USA University of Rochester, Rochester, NY, USA IWK Health Centre and Dalhousie University, Halifax, Nova Scotia, Canada Cephalon, Inc., Frazer, PA, USA National Institutes of Health, Bethesda, MD, USA qd consulting, LLC, Research Triangle Park, NC, USA Johnson & Johnson Pharmaceutical Research & Development LLC, Raritan, NJ, USA National Cancer Institute, National Institutes of Health, Bethesda, MD, USA Merck & Company, Blue Bell, PA, USA Faculdade de Medicina de Lisboa, Lisbon, Portugal Mt. Sinai School of Medicine, New York, NY, USA Alpharma, Piscataway, NJ, USA University of Lucerne and Swiss Paraplegic Research, Lucerne, Switzerland NeurogesX, Inc., San Carlos, CA, USA Endo Pharmaceuticals Inc., Chadds Ford, PA, USA.

PMID: 20207481
DOI: 10.1016/j.pain.2010.02.018

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.

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References

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[1] Altman R, Alarcon G, Appelrouth D, Bloch D, Borenstein D, Brandt K, Brown C, Cooke TD, Daniel W, Feldman D. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hip. Arthritis Rheum. 1991;34:505-514.

[2] Altman R, Alarcon G, Appelrouth D, Bloch D, Borenstein D, Brandt K, Brown C, Cooke TD, Daniel W, Feldman D. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hip. Arthritis Rheum. 1991;34:505-514.

[3] Altman A, Brandt K, Hochberg M, Moskowitz R, Bellamy N, Bloch DA, Buckwalter J, Dougados M, Ehrlich G, Lequesne M, Lohmander S, Murphy WA Jr, Rosario-Jansen T, Schwartz B, Trippel S. Design and conduct of clinical trials in patients with osteoarthritis: recommendations from a task force of the Osteoarthritis Research Society: results from a workshop. Osteoarthritis Cartilage. 1996;4:217-243.

[4] Altman A, Brandt K, Hochberg M, Moskowitz R, Bellamy N, Bloch DA, Buckwalter J, Dougados M, Ehrlich G, Lequesne M, Lohmander S, Murphy WA Jr, Rosario-Jansen T, Schwartz B, Trippel S. Design and conduct of clinical trials in patients with osteoarthritis: recommendations from a task force of the Osteoarthritis Research Society: results from a workshop. Osteoarthritis Cartilage. 1996;4:217-243.

[5] Arends LR, Hoes AW, Lubsen J, Grobbee DE, Stijnen T. Baseline risk as predictor of treatment benefit: three clinical meta-re-analyses. Stat Med. 2000;19:3497-3518.

[6] Arends LR, Hoes AW, Lubsen J, Grobbee DE, Stijnen T. Baseline risk as predictor of treatment benefit: three clinical meta-re-analyses. Stat Med. 2000;19:3497-3518.

[7] Arnold LM, Crofford LJ, Martin SA, Young JP, Sharma U. The effect of anxiety and depression on improvements in pain in a randomized, controlled trial of pregabalin for treatment of fibromyalgia. Pain Med. 2007;8:633-638.

[8] Arnold LM, Crofford LJ, Martin SA, Young JP, Sharma U. The effect of anxiety and depression on improvements in pain in a randomized, controlled trial of pregabalin for treatment of fibromyalgia. Pain Med. 2007;8:633-638.

[9] Arnold LM, Lu Y, Crofford LJ, Wohlreich M, Detke MJ, Iyengar S, Goldstein DJ. A double-blind, multicenter trial comparing duloxetine with placebo in the treatment of fibromyalgia patients with or without major depressive disorder. Arthritis Rheum. 2004;50:2974-2984.

[10] Arnold LM, Lu Y, Crofford LJ, Wohlreich M, Detke MJ, Iyengar S, Goldstein DJ. A double-blind, multicenter trial comparing duloxetine with placebo in the treatment of fibromyalgia patients with or without major depressive disorder. Arthritis Rheum. 2004;50:2974-2984.

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

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