Analgesic Clinical Trial Innovations,Opportunities,and Networks(ACTION)

项目概要/摘要 数百万美国人经历急性和慢性疼痛。尽管取得了相当大的进展 确定急性和慢性疼痛的病理生理机制， 不足因此，公共卫生迫切需要发展 改善疗效、安全性和耐受性的治疗。不幸的是，许多止痛药 在最近的随机临床试验中检查的治疗没有显示出有效性。的 这些负面结果的解释是未知的，提出了关于能力的问题。 慢性疼痛临床试验，以区分有效治疗与安慰剂或疗效较差的治疗 治疗（即，测定灵敏度）。患者特征、临床试验研究设计和 方法、结果测量、数据分析方法和统计能力都可能发挥作用， 解释证明有效镇痛药获益的困难的作用 治疗与安慰剂。确定与下列因素相关的特定临床试验特征 现有数据中的检测灵敏度有可能建立一种循证方法， 镇痛药临床试验的设计。美国食品和药物管理局最近推出了 镇痛药临床试验创新，机会和网络（行动），一个公私合营的 旨在促进发现和开发镇痛剂的伙伴关系， 有效性、安全性和耐受性。行动将建立一个合作 优先考虑研究目标的倡议，开发标准化的止痛药数据库平台， 并进行方法学重点研究，以提高检测灵敏度和效率， 镇痛药临床试验这些研究和其他活动的结果有可能 告知并加速开发各种类型的改善疼痛管理干预措施， 而不仅仅是药物治疗。

Project Summary/Abstract Millions of American experience acute and chronic pain. Despite considerable progress identifying pathophysiologic mechanisms of acute and chronic pain, available treatments remain inadequate. Consequently, there is a compelling public health need for the development of treatments with improved efficacy, safety, and tolerability. Unfortunately, numerous analgesic treatments examined in recent randomized clinical trials have failed to show efficacy. The explanations for these negative results are unknown, raising questions about the ability of clinical trials in chronic pain to distinguish efficacious treatments from placebo or less efficacious treatments (i.e., assay sensitivity). Patient characteristics, clinical trial research designs and methods, outcome measures, approaches to data analysis, and statistical power may all play a role in accounting for difficulties in demonstrating the benefits of efficacious analgesic treatments vs. placebo. The identification of specific clinical trial characteristics associated with assay sensitivity in existing data has the potential to establish an evidence-based approach to the design of analgesic clinical trials. The U.S. Food and Drug Administration recently launched Analgesic Clinical Trial Innovations, Opportunities, and Networks (ACTION), a public-private partnership intended to facilitate the discovery and development of analgesics with improved efficacy, safety, and tolerability for acute and chronic pain. ACTION will establish a collaborative initiative to prioritize research objectives, develop a standardized analgesic database platform, and conduct methodologically-focused studies to increase the assay sensitivity and efficiency of analgesic clinical trials. The results of these studies and other activities have the potential to inform and accelerate the development of improved pain management interventions of all types, not just pharmacologic treatments.