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

Dworkin, Robert H., Turk, Dennis C., Peirce-Sandner, Sarah, Baron, Ralf, Bellamy, Nicholas, Burke, Laurie B., Chappell, Amy, Chartier, Kevin, Cleeland, Charles S., Costello, Ann, Cowan, Penney, Dimitrova, Rozalina, Ellenberg, Susan, Farrar, John T., French, Jacqueline A., Gilron, Ian, Hertz, Sharon, Jadad, Alejandro R., Jay, Gary W., Kalliomäki, Jarkko, Katz, Nathaniel P., Kerns, Robert D., Manning, Donald C., McDermott, Michael P., McGrath, Patrick J., Narayana, Arvind, Porter, Linda, Quessy, Steve, Rappaport, Bob A., Rauschkolb, Christine, Reeve, Bryce B., Rhodes, Thomas, Sampaio, Cristina, Simpson, David M., Stauffer, Joseph W., Stucki, Gerold, Tobias, Jeffrey, White, Richard E., Witter, James·2010·Pain

DOI 10.1016/j.pain.2010.02.018

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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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Authors: Dworkin, R. H., Turk, D. C., Peirce-Sandner, S., Baron, R., Bellamy, N., Burke, L. B., Chappell, A., Chartier, K., Cleeland, C. S., Costello, A., Cowan, P., Dimitrova, R., Ellenberg, S., Farrar, J. T., French, J. A., Gilron, I., Hertz, S., Jadad, A. R., Jay, G. W., Kalliomäki, J., Katz, N. P., Kerns, R. D., Manning, D. C., McDermott, M. P., McGrath, P. J., Narayana, A., Porter, L., Quessy, S., Rappaport, B. A., Rauschkolb, C., Reeve, B. B., Rhodes, T., Sampaio, C., Simpson, D. M., Stauffer, J. W., Stucki, G., Tobias, J., White, R. E., & Witter, J.
Affiliations: Dalhousie University (CA)
University of Washington (US)
Christian-Albrechts-Universität zu Kiel (DE)
The University of Queensland (AU)
United States Food and Drug Administration (US)
Eli Lilly (United States) (US)
The University of Texas MD Anderson Cancer Center (US)
American Chronic Pain Association (US)
New York University (US)
Queen's University (CA)
University of Toronto (CA)
AstraZeneca (Sweden) (SE)
United States Department of Veterans Affairs (US)
University of Rochester (US)
Izaak Walton Killam Health Centre (CA)
National Institutes of Health (US)
Janssen Research & Development (United States) (US)
Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
University of Lisbon (PT)
University of Rochester Medicine (US)
University of Lucerne (CH)
Corresponding author: Dworkin, Robert H.
ORCID: Dworkin, Robert H.
Baron, Ralf
Burke, Laurie B.
Cleeland, Charles S.
Ellenberg, Susan
Farrar, John T.
French, Jacqueline A.
Gilron, Ian
Hertz, Sharon
Jadad, Alejandro R.
Katz, Nathaniel P.
Kerns, Robert D.
McDermott, Michael P.
McGrath, Patrick J.
Reeve, Bryce B.
Rhodes, Thomas
Sampaio, Cristina
Simpson, David M.
Stucki, Gerold
Tobias, Jeffrey
Venue: Pain
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2010-05
Volume: 149
Issue: 2
Pages: 177-193
ISSN: 0304-3959 (ISSN-L)
DOI: 10.1016/j.pain.2010.02.018
OpenAlex: W2061974517
Cited by: 381
References: 158
Citations by year: 2026: 6 · 2025: 18 · 2024: 11 · 2023: 21 · 2022: 39 · 2021: 23 · 2020: 27 · 2019: 27 · 2018: 19 · 2017: 20 · 2016: 24 · 2015: 20 · 2014: 27 · 2013: 36 · 2012: 27
FWCI: 27.01
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Pain (publishedVersion)
PubMed (publishedVersion)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Musculoskeletal pain and rehabilitation
Health Sciences › Medicine › Physiology (medical) › Pain Mechanisms and Treatments
Keywords: chronic pain, confirmatory trials, research design, IMMPACT, clinical trial design, participant selection, assay sensitivity, analgesic efficacy, placebo response
MeSH terms: Analgesics, Clinical Trials as Topic, Dose-Response Relationship, Drug, Drug Administration Schedule, Humans, Pain Measurement, Pain, Intractable, Intractable Pain, Random Allocation, Research Design, Outcome Assessment, Health Care, Patient Selection

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

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