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

镇痛、麻醉和成瘾临床试验翻译、创新、机会和网络 (ACTTION) 公私合作伙伴关系

• 批准号: 9297674
• 负责人: Robert H Dworkin
• 金额: $ 50万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-15 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9297674
• 关键词: Analgesic; Anesthetic; Addiction; Clinical; Trial

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.

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 亿成年人表示经历过疼痛 在过去 3 个月内，大约 50% 的人表示他们的影响 疼痛为中度或重度。慢性疼痛与直接（例如医疗保健）和间接相关 （例如残疾）费用估计每年在 560-6350 亿美元之间。虽然 在理解疼痛的病理生理机制、 最广泛用于治疗急性和慢性疼痛的药物——非甾体类抗炎药 和阿片类镇痛药——具有重大缺点，包括功效有限和可能存在的重大风险 限制长期使用。因此，迫切需要发展公共健康 具有更高疗效和安全性的治疗方法。不幸的是，许多镇痛治疗方法在 最近的随机临床试验未能显示疗效。对这些结果的解释是 未知，这引发了人们对临床试验区分有效治疗和治疗的能力的质疑。 安慰剂或效果较差的治疗（即检测灵敏度）。患者特征、临床试验 研究方法、结果衡量、数据分析方法和统计能力都可能发挥作用 解释在证明有效治疗的益处方面的困难的作用。鉴定 与更高的检测灵敏度相关的特定临床试验特征和开发 具有更大有效性的结果测量可以为基于证据的方法提供基础 临床试验的设计，不仅涉及疼痛治疗，还涉及其他治疗领域。初级 镇痛、麻醉和成瘾临床试验翻译创新的目标， 机会和网络（ACTTION）公私伙伴关系旨在促进发展 具有改善功效的新型镇痛、麻醉、成瘾和周围神经病变干预措施 和安全。行动是一项多学科合作，优先考虑研究和其他举措 实现这一目标。行动伙伴关系的主要活动包括开展系统性的 审查、共识会议和以方法论为重点的研究以及开发和 合格的新型临床结果评估，旨在提高检测灵敏度和 临床试验的信息量。这些努力的结果有可能提供信息并加速 开发针对疼痛、麻醉和镇静、成瘾和外周疾病的改进治疗方法 神经病。