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

• Published in: Pain (Amsterdam) Vol. 149; no. 2; pp. 177 - 193
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: Philadelphia, PA Elsevier B.V 01.05.2010; Lippincott Williams & Wilkins, Inc; Elsevier
• Subjects: Analgesics; Analgesics - administration & dosage; Analgesics - adverse effects; Biological and medical sciences; Chronic pain; Clinical Trials as Topic - methods; Clinical Trials as Topic - standards; Dose-Response Relationship, Drug; Drug Administration Schedule; Fundamental and applied biological sciences. Psychology; Humans; Illness and personality; Illness, stress and coping; Medical sciences; Neuropharmacology; Outcome Assessment, Health Care - methods; Outcome Assessment, Health Care - standards; Pain Measurement - methods; Pain Measurement - standards; Pain, Intractable - drug therapy; Patient Selection; Pharmacology. Drug treatments; Phase 3 trials; Psychology and medicine; Psychology. Psychoanalysis. Psychiatry; Psychology. Psychophysiology; Random Allocation; Randomized clinical trials; Research design; Research Design - standards; Subject selection; Research design; Randomized clinical trials; Phase 3 trials; Subject selection; Chronic pain; Evaluation; Variability; Attention; Recommendation; Sensitivity; Analgesic; Pain; Treatment; Placebo; Clinical trial
• ISSN: 0304-3959; 1872-6623; 1872-6623
• DOI: 10.1016/j.pain.2010.02.018

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 o...