Analgesic, Anesthetic and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks and Pediatric Anesthesia Safety Initiative (ACTTION/PASI) (U01)

改进治疗方法的发展和对现有干预措施的更好了解 将解决因有限的疗效和安全性而造成的巨大公共卫生负担 现有的疼痛治疗，阿片类药物和兴奋剂成瘾的日益普遍， 成人麻醉(例如，术后精神错乱)和潜在的发育神经毒性 与儿科麻醉有关，特别是对易受伤害的儿童。令人信服的理由 提供了开发新的范例来确定具有更高的有效性和安全性的治疗方法 由于现有方法在确定新疗法方面的局限性，不充分 对阴性和非决定性临床试验解释的理解，不完整 治疗风险的特征，以及对与临床相关的因素缺乏了解 试验检测灵敏度。本申请书中描述的公私伙伴关系的使命 将是“确定、优先、赞助、协调和促进创新活动--重点 关于最大化治疗收益和最小化风险--这将加速发现 以及改进的止痛剂、成瘾剂、成人和儿童麻醉剂的开发 为公众健康造福的治疗。该伙伴关系的主要目标将是 提供多学科协作框架，以确定研究目标和实施的优先顺序 以方法为重点的研究和其他活动，以促进发现和发展 止痛剂、成瘾和麻醉干预措施的有效性和安全性更高。在每一个中 在这些治疗领域，有多种机会发展创新研究 可以加速将临床前研究成果转化为第二阶段和第三阶段的方法 临床试验和对真实世界数据和证据的有意义的研究。有系统地努力 提高临床试验和其他类型临床研究的效率和信息量 检测疗效和有效性，确定患者偏好，并改进评估 安全性-例如，通过分析临床前研究的方法和结果， 随机临床试验和严格的观察性研究-可以为 对未来研究的设计和解释提出循证建议。至 为了实现其目标，伙伴关系将包括来自学术界、多个 专业协会、政府机构、患者权益倡导组织和行业。这个 公私伙伴关系的首要目标和承诺是改善人民的生活 为所有年龄段的患者提供医疗服务，从而为公共卫生做出有意义的贡献。

The development of improved treatments and greater understanding of existing interventions will address the enormous public health burden resulting from limited efficacy and safety of existing pain treatments, increasing prevalence of opioid and stimulant addiction, safety risks of adult anesthesia (e.g., post-operative delirium), and potential developmental neurotoxicities associated with pediatric anesthesia, especially in vulnerable children. A compelling rationale for developing new paradigms to identify treatments with improved efficacy and safety is provided by the limitations of existing approaches to identifying novel treatments, inadequate understanding of the explanations for negative and inconclusive clinical trials, incomplete characterizations of treatment risks, and lack of knowledge of factors associated with clinical trial assay sensitivity. The mission of the public-private partnership described in this application will be to “identify, prioritize, sponsor, coordinate, and promote innovative activities — focusing on maximizing treatment benefits and minimizing their risks — that will expedite the discovery and development of improved analgesic, addiction, and adult and pediatric anesthetic treatments for the benefit of the public health.” The major objective of the partnership will be to provide a multidisciplinary collaborative framework to prioritize research objectives and conduct methodologically-focused studies and other activities to facilitate the discovery and development of analgesic, addiction, and anesthetic interventions with greater efficacy and safety. In each of these therapeutic areas, there are multiple opportunities to develop innovative research methods that can accelerate the translation of preclinical research results to phase 2 and 3 clinical trials and to meaningful studies of real-world data and evidence. Systematic efforts to increase the efficiency and informativeness of clinical trials and other types of clinical research to detect efficacy and effectiveness, determine patient preferences, and improve assessments of safety — for example, by analyzing the methods and results of preclinical studies, randomized clinical trials, and rigorous observational studies — can provide the foundation for evidence-based recommendations for the design and interpretation of future research. To achieve its objectives, the partnership will include representatives from academia, multiple professional societies, government agencies, patient advocacy organizations, and industry. The overarching goals and promise of the public-private partnership are to improve the lives of patients of all ages and thereby contribute meaningful benefits to the public health.