确证性慢性疼痛临床试验的研究设计考虑因素：IMMPACT 建议。
Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations.
机构信息
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.
出版信息
Pain. 2010 May;149(2):177-193. doi: 10.1016/j.pain.2010.02.018. Epub 2010 Mar 6.
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.
尽管先前的研究表明可能会有疗效，但在主要疗效分析中，评估的治疗方法与安慰剂相比并没有显著差异的慢性疼痛临床试验数量有所增加。这些发现可能反映了真正的无效性，或者这些试验在方法学和其他方面存在缺陷，从而无法证明疗效。在重要的研究设计考虑因素方面，慢性疼痛临床试验存在很大的差异，确定和解决任何方法学上的弱点都将提高证明新干预措施镇痛效果的可能性。因此，召开了一次 IMMPACT 共识会议，以确定确认性慢性疼痛试验的关键研究设计考虑因素，并为其实施提出建议。我们提出了确认性慢性疼痛临床试验的主要组成部分的建议，包括参与者选择、试验阶段和持续时间、治疗组和剂量方案以及试验类型。更多地关注和研究确认性慢性疼痛临床试验的方法学方面有可能提高其检测灵敏度，并最终为慢性疼痛治疗提供更有意义的评估。
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