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: 9759869
• 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/9759869
• 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1亿成年人报告经历过疼痛 在过去的3个月里，大约50%的人报告说， 疼痛为中度或重度。慢性疼痛与直接（例如，保健）和间接 (e.g.,残疾）的费用估计每年在5600亿至6350亿美元之间。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， 最广泛的急性和慢性疼痛处方药-非甾体抗炎药 和阿片类镇痛药--存在重大缺点，包括疗效不高和存在重大风险， 限制长期使用。因此，公共卫生迫切需要发展 提高疗效和安全性的治疗。不幸的是，许多镇痛治疗检查， 最近的随机临床试验没有显示出有效性。对这些结果的解释是 未知，提出了关于临床试验区分有效治疗和 安慰剂或不太有效的治疗（即，测定灵敏度）。患者特征，临床试验 研究方法、结果测量、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的困难方面的作用。识别 与更高检测灵敏度相关的特定临床试验特征以及 具有更高有效性的结果测量可以为循证方法提供基础， 临床试验的设计，不仅是疼痛治疗，也包括其他治疗领域。主 镇痛药、麻醉药和成瘾临床试验翻译创新的目的， 机会和网络（ACTTION）公私伙伴关系的目的是促进 具有改善疗效的新型镇痛、麻醉、成瘾和周围神经病变干预 和安全性ACTTION是一个多学科的合作，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的 审查、共识会议和以方法为重点的研究，以及开发和 鉴定新的临床结局评估，目的是提高检测灵敏度， 临床试验的信息性。这些努力的结果有可能为信息和加速 改善疼痛、麻醉和镇静、成瘾和外周血管疾病的治疗方法 神经病变