Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) Public-Private Partnership

在美国，疼痛是导致患者咨询医生的最常见症状。 根据2012年全国健康访谈调查，超过1亿成年人报告经历过疼痛 在过去的3个月内，大约50%的人报告说，他们的影响 疼痛为中度或重度。慢性疼痛与直接的(例如，保健)和间接的有关 (例如，残疾)费用估计在每年5,600-6,350亿美元之间。虽然 在理解疼痛的病理生理机制方面已经取得了相当大的进展， 最广泛用于急慢性疼痛的处方药物--非类固醇抗炎药 和阿片类镇痛剂-有重大缺点，包括适度的疗效和重大风险， 限制长期使用。因此，有一个迫切的公共卫生需求的发展 提高疗效和安全性的治疗方法。不幸的是，许多止痛药治疗在 最近的随机临床试验未能显示出疗效。对这些结果的解释如下 未知，引发了人们对临床试验区分有效治疗和 安慰剂或疗效较差的治疗(即，化验敏感性)。患者特征、临床试验 研究方法、结果衡量标准、数据分析方法和统计能力都可能发挥作用 在解释证明有效治疗的益处方面的困难方面发挥的作用。身份识别 与更高的化验灵敏度和发展相关的特定临床试验特征 具有更高有效性的结果衡量标准可以为循证方法提供基础 不仅在疼痛治疗方面，而且在其他治疗领域的临床试验的设计。初级阶段 止痛药、麻醉剂和成瘾临床试验翻译创新的目标， 机会和网络(ACTTION)公私伙伴关系是为了促进 新的止痛剂、麻醉剂、成瘾和周围神经病变干预措施的有效性得到改善 和安全。ACTTION是一个多学科合作，优先考虑研究和其他倡议，以 实现这一目标。ACTTION伙伴关系的主要活动包括 审查、协商一致会议和以方法为重点的研究以及制定和 鉴定新的临床结果评估，目的是提高分析的灵敏度和 临床试验的信息性。这些努力的结果有可能通报并加速 疼痛、麻醉和镇静、成瘾和外周治疗的改进进展 神经病。

Pain is the most common symptom leading patients to consult a physician in the United States. According to the 2012 National Health Interview Survey, over 100 million adults report experiencing pain within the past 3 months, and approximately 50% of these individuals reported that the impact of their pain was moderate or severe. Chronic pain is associated with both direct (e.g., health care) and indirect (e.g., disability) costs that have been estimated to range from $560-635 billion annually. Although considerable progress has been made in understanding the pathophysiologic mechanisms of pain, the most widely prescribed medications for acute and chronic pain—non-steroidal anti-inflammatory drugs and opioid analgesics—have major shortcomings, including modest efficacy and significant risks that can limit long-term use. Consequently, there is a compelling public health need for the development of treatments with improved efficacy and safety. Unfortunately, many analgesic treatments examined in recent randomized clinical trials have failed to show efficacy. The explanations for these results are unknown, raising questions about the ability of clinical trials to distinguish efficacious treatments from placebo or less efficacious treatments (i.e., assay sensitivity). Patient characteristics, clinical trial research 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 treatments. The identification of specific clinical trial characteristics associated with greater assay sensitivity and the development of outcome measures with greater validity can provide the foundation for an evidence-based approach to the design of clinical trials, not only of pain treatment but also in other therapeutic areas. The primary objective of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations Innovations, Opportunities, and Networks (ACTTION) public-private partnership is to facilitate the development of novel analgesic, anesthetic, addiction, and peripheral neuropathy interventions with improved efficacy and safety. ACTTION is a multidisciplinary collaboration that prioritizes research and other initiatives to achieve this objective. The major activities of the ACTTION partnership include conducting systematic reviews, consensus meetings, and methodologically-focused studies as well as developing and qualifying novel clinical outcome assessments with the aim of increasing the assay sensitivity and informativeness of clinical trials. The results of these efforts have the potential to inform and accelerate the development of improved treatments for pain, anesthesia and sedation, addiction, and peripheral neuropathy.