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

项目摘要/摘要 数以百万计的美国人经历着急性和慢性疼痛。尽管取得了长足的进步 确定急性和慢性疼痛的病理生理机制，现有的治疗方法仍然存在 不够充分。因此，有一个迫切的公共卫生需求的发展 提高疗效、安全性和耐受性的治疗。不幸的是，很多止痛药 在最近的随机临床试验中检查的治疗方法未能显示出疗效。这个 对这些负面结果的解释尚不清楚，这引发了人们对 慢性疼痛的临床试验区分有效的治疗与安慰剂或较差的有效 处理(即，化验敏感性)。患者特征、临床试验研究设计和 方法、结果衡量标准、数据分析方法和统计能力都可能发挥作用 在说明有效止痛药的益处方面所起的作用 治疗与安慰剂的对比。确定与以下因素相关的特定临床试验特征 现有数据中的化验敏感性有可能建立一种基于证据的方法来 止痛临床试验设计。美国食品和药物管理局最近启动了 公私合营的止痛临床试验创新、机会和网络(ACTION) 旨在促进止痛药的发现和开发的伙伴关系 对急性和慢性疼痛的有效性、安全性和耐受性。行动将建立一个协作的 倡议确定研究目标的优先顺序，开发标准化的止痛药数据库平台， 并进行以方法为重点的研究，以提高检测的灵敏度和效率 止痛临床试验。这些研究和其他活动的结果有可能 告知并加速制定各种改进的疼痛管理干预措施， 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.