. 2012 Jun;153(6):1148-1158.

doi: 10.1016/j.pain.2012.03.003. Epub 2012 Apr 9.

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

Affiliations

Affiliation

¹ Departments of Anesthesiology and Neurology and Center for Human Experimental Therapeutics, University of Rochester, Rochester, NY 14642, USA University of Washington, Seattle, WA, USA University of Rochester, Rochester, NY, USA United States Food and Drug Administration, Silver Spring, MD, USA University of Pennsylvania, Philadelphia, PA, USA Queen's University, Kingston, ON, Canada Analgesic Solutions, Natick, MA, USA Tufts University, Boston, MA, USA Johns Hopkins University, Baltimore, MD, USA California Pacific Medical Center Research Institute, San Francisco, CA, USA University of Wisconsin, Madison, WI, USA University of Kiel, Kiel, Germany University of Queensland, Brisbane, Australia Bristol-Myers Squibb, Wallingford, CT, USA American Chronic Pain Association, Rocklin, CA, USA DePuy Spine, Raynham, MA, USA Pfizer, New London, CT, USA Eisai Limited, Mosquito Way, Hatfield, UK Department of Veterans Affairs, West Haven, CT, USA Yale University, New Haven, CT, USA Nuvo Research, West Chester, PA, USA Endo Pharmaceuticals Inc., Chadds Ford, PA, USA Durect Corporation, Cupertino, CA, USA AstraZeneca, Wilmington, DE, USA Purdue Pharma, Stamford, CT, USA National Institutes of Health, Bethesda, MD, USA Johnson & Johnson Pharmaceutical Research & Development, Titusville, NJ, USA Imperial College, London, UK Faculdade de Medicina de Lisboa, Lisbon, Portugal Eli Lilly & Co., Indianapolis, IN, USA King Pharmaceuticals (currently Pfizer), Cary, NC, USA Oregon Health and Science University, Portland, OR, USA Grünenthal GmbH, Aachen, Germany NeurogesX, Inc., San Carlos, CA, USA Harvard Medical School, Boston, MA, USA University of Ottawa, Ottawa, ON, Canada Smith & Nephew, Durham, NC, USA German Diabetes Center, Heinrich Heine University, Düsseldorf, Germany.

PMID: 22494920
DOI: 10.1016/j.pain.2012.03.003

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

Robert H Dworkin et al. Pain. 2012 Jun.

. 2012 Jun;153(6):1148-1158.

doi: 10.1016/j.pain.2012.03.003. Epub 2012 Apr 9.

Authors

Affiliation

¹ Departments of Anesthesiology and Neurology and Center for Human Experimental Therapeutics, University of Rochester, Rochester, NY 14642, USA University of Washington, Seattle, WA, USA University of Rochester, Rochester, NY, USA United States Food and Drug Administration, Silver Spring, MD, USA University of Pennsylvania, Philadelphia, PA, USA Queen's University, Kingston, ON, Canada Analgesic Solutions, Natick, MA, USA Tufts University, Boston, MA, USA Johns Hopkins University, Baltimore, MD, USA California Pacific Medical Center Research Institute, San Francisco, CA, USA University of Wisconsin, Madison, WI, USA University of Kiel, Kiel, Germany University of Queensland, Brisbane, Australia Bristol-Myers Squibb, Wallingford, CT, USA American Chronic Pain Association, Rocklin, CA, USA DePuy Spine, Raynham, MA, USA Pfizer, New London, CT, USA Eisai Limited, Mosquito Way, Hatfield, UK Department of Veterans Affairs, West Haven, CT, USA Yale University, New Haven, CT, USA Nuvo Research, West Chester, PA, USA Endo Pharmaceuticals Inc., Chadds Ford, PA, USA Durect Corporation, Cupertino, CA, USA AstraZeneca, Wilmington, DE, USA Purdue Pharma, Stamford, CT, USA National Institutes of Health, Bethesda, MD, USA Johnson & Johnson Pharmaceutical Research & Development, Titusville, NJ, USA Imperial College, London, UK Faculdade de Medicina de Lisboa, Lisbon, Portugal Eli Lilly & Co., Indianapolis, IN, USA King Pharmaceuticals (currently Pfizer), Cary, NC, USA Oregon Health and Science University, Portland, OR, USA Grünenthal GmbH, Aachen, Germany NeurogesX, Inc., San Carlos, CA, USA Harvard Medical School, Boston, MA, USA University of Ottawa, Ottawa, ON, Canada Smith & Nephew, Durham, NC, USA German Diabetes Center, Heinrich Heine University, Düsseldorf, Germany.

PMID: 22494920
DOI: 10.1016/j.pain.2012.03.003

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.

PubMed Disclaimer

Comment in

Assay sensitivity in clinical trials with chronic pain patients.
Treede RD. Treede RD. Pain. 2012 Jun;153(6):1136-1137. doi: 10.1016/j.pain.2012.03.015. Epub 2012 Mar 28. Pain. 2012. PMID: 22463822 No abstract available.

Cited by

Predicting Treatment Responses in Patients With Osteoarthritis: Results From Two Phase III Tanezumab Randomized Clinical Trials.
Colloca L, Dworkin RH, Farrar JT, Tive L, Yang J, Viktrup L, Dasic G, West CR, Whalen E, Brown MT, Gilbert SA, Verburg KM. Colloca L, et al. Clin Pharmacol Ther. 2023 Apr;113(4):878-886. doi: 10.1002/cpt.2842. Epub 2023 Jan 31. Clin Pharmacol Ther. 2023. PMID: 36621827 Free PMC article.
Accelerating the Drug Delivery Pipeline for Acute and Chronic Pancreatitis: Summary of the Working Group on Drug Development and Trials in Chronic Pancreatitis at the National Institute of Diabetes and Digestive and Kidney Diseases Workshop.
Forsmark CE, Andersen DK, Farrar JT, Golden M, Habtezion A, Husain SZ, Li L, Mayerle J, Pandol SJ, Uc A, Zhu Z, Yadav D. Forsmark CE, et al. Pancreas. 2018 Nov/Dec;47(10):1200-1207. doi: 10.1097/MPA.0000000000001174. Pancreas. 2018. PMID: 30325858 Free PMC article.
Methadone patient-controlled analgesia for postoperative pain: a randomized, controlled, double-blind study.
Neto JO, Machado MD, de Almeida Correa M, Scomparim HA, Posso IP, Ashmawi HA. Neto JO, et al. J Anesth. 2014 Aug;28(4):505-10. doi: 10.1007/s00540-013-1785-3. Epub 2014 Jan 21. J Anesth. 2014. PMID: 24445560 Clinical Trial.
Impact of chronic pelvic pain and painful bladder syndrome on the Pittsburgh Sleep Quality Index on women with deep endometriosis: a cross-sectional study.
de Souza RJ, Villela NR, Brollo LCS, Oliveira MAP. de Souza RJ, et al. Int Urogynecol J. 2023 Oct;34(10):2487-2493. doi: 10.1007/s00192-023-05560-y. Epub 2023 May 20. Int Urogynecol J. 2023. PMID: 37209169
Astym treatment vs. eccentric exercise for lateral elbow tendinopathy: a randomized controlled clinical trial.
Sevier TL, Stegink-Jansen CW. Sevier TL, et al. PeerJ. 2015 May 19;3:e967. doi: 10.7717/peerj.967. eCollection 2015. PeerJ. 2015. PMID: 26038722 Free PMC article.

See all "Cited by" articles

References

1. Allen KD, Coffman CJ, Golightly YM, Stechuchak KM, Voils CI, Keefe FJ. Comparison of pain measures among patients with osteoarthritis. J Pain. 2010;11:522-527.
1. Altman R, Brandt K, Hochberg M, Moskowitz R. Design and conduct of clinical trials in patients with osteoarthritis: recommendations from a task force of the Osteoarthritis Research Society. Osteoarthritis Cartilage. 1996;4:217-243.
1. Altman RD, Marcussen KC. Effects of a ginger extract on knee pain in patients with osteoarthritis. Arthritis Rheum. 2001;44:2531-2538.
1. Attal N, Bouhassira D, Baron R, Dostrovsky J, Dworkin RH, Finnerup N, Gourlay G, Haanpää M, Raja S, Rice ASC, Simpson D, Treede RD, Wells CD. Assessing symptom profiles in neuropathic pain clinical trials: can it improve outcome? Eur J Pain. 2011;15:441-443.
1. Attal N, Cruccu G, Baron R, Haanpää M, Hansson P, Jensen TS, Nurmikko T. EFNS guidelines on the pharmacological treatment of neuropathic pain: 2009 revision. Eur J Neurol. 2010;17:1113-1123.

Publication types

Actions
Actions
Actions
Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Substances

Actions

LinkOut - more resources

Full Text Sources
Medical
- ClinicalTrials.gov
- MedlinePlus Health Information

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

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

Affiliation

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

Authors

Affiliation

Abstract

Comment in

Similar articles

Cited by

References

Publication types

MeSH terms

Substances

LinkOut - more resources

Full Text Sources

Medical

Abstract

Comment in

Similar articles

Cited by

References

Publication types

MeSH terms

Substances

Related information

LinkOut - more resources

Full Text Sources

Medical