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Considerations for improving assay sensitivity in chronic pain clinical trials: IMMPACT recommendations
Robert H Dworkin1, Dennis C Turk, Sarah Peirce-Sandner
1Departments 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.
Many pain medication trials fail to show benefits due to low assay sensitivity. Improving trial design and methods can help accurately identify effective analgesics and reduce falsely negative results.
Area of Science:
- Pharmacology and Clinical Trial Methodology
- Pain Management and Analgesic Research
Background:
- Recent randomized clinical trials (RCTs) for pain treatments have shown non-significant results compared to placebo, despite prior evidence of efficacy.
- This may indicate limitations in the "assay sensitivity" of these trials, hindering the detection of benefits from effective analgesics.
Framework:
- An Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials consensus meeting addressed the assay sensitivity of chronic pain trials.
- Key factors influencing assay sensitivity were reviewed, including patient characteristics, study design, clinical site factors, and outcome measures.
Implementation:
- Recommendations focus on optimizing patient selection, study design elements, and site management.
- Enhancing outcome measurement tools and methodologies is crucial for improving trial sensitivity.
Implications:
- Addressing assay sensitivity can decrease the number of falsely negative trials for efficacious pain medications.
- Improved trial design will enhance the efficiency of analgesic drug development and expedite the identification of safe and effective pain treatments.
