Increasing the Quality and Efficiency of Clinical Trials (R18)

提高临床试验的质量和效率 (R18)

• 批准号: 8883023
• 负责人: JENNIFER S LI
• 金额: $ 750万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8883023
• 关键词: Increasing; Quality; Efficiency; Clinical; Trials

Abstract Since 1962, when Congress (Kefauver-Harris Amendment) charged the FDA with the responsibility to ensure that each pharmaceutical approved for medical use in the US be shown to be safe and effective, clinical trials have formed the foundation for understanding the balance of benefits and risks associated with the use of medical products. In recent decades, however, clinical trials have become prohibitively expensive, slow to finish, and are often under-enrolled, presenting physicians and patients with major gaps in knowledge about what treatments work for which patients. Addressing these gaps by improving the efficiency and quality of clinical trials is the overarching purpose of the Clinical Trials Transformation Initiative (CTTI). Since its inception in 2007, CTTI—cofounded by Duke University and the U.S. Food and Drug Administration (FDA), and hosted by Duke—has sought to identify and promote practices that will improve the quality and efficiency of clinical trials. CTTI projects address a broad range of trial design and operational issues by focusing on quality, relevance, and efficiency. Examples of these issues include informed consent, subject recruitment, use of central institutional review boards (IRBs), investigational new drug (IND) safety reporting, clinical trial quality, operations and monitoring, and antibacterial drug development, all of which are directly relevant to FDA's mission (Appendix A: CTTI Project Portfolio). Clinical trials comprise a vast number of stakeholders collectively identified by the Institute of Medicine as the Clinical Trials Enterprise (CTE). All CTE stakeholders are represented in CTTI projects, so that recommendations can be implemented and consensus can be reached regarding the potential to encompass improvements in quality and efficiency. CTTI's strategy involves a three-pronged approach: 1) incremental improvement to clinical trial methods and processes; 2) better understanding of the national research portfolio to improve the matching of trials to public health priorities; and 3) a push for transformational change that will provide more than incremental improvements (Appendix B: Strategic Plan). CTTI's work is not limited to recommendations, but also includes the creation of tools and other approaches to facilitate adoption of its recommendations. The overarching goals of this proposal are twofold: 1) To maintain a sustainable administrative and scientific infrastructure that will show the path forward to high-quality, efficient, and influential clinical trials by leveraging a broad and transparent public-private partnership (PPP) to provide best practices and recommendations for reducing research impediments in the conduct of clinical trials; and 2) To subsequently disseminate and facilitate adoption of issued recommendations and findings.

抽象的 自1962年以来，国会（Kefauver-Harris修正案）负责FDA有责任确保 证明在美国批准医疗用途的每种药物都被证明是安全有效的临床试验 已经为了解与使用相关的利益和风险的平衡构成了基础 医疗产品。然而，最近几十年，临床试验已被禁止 完成，并且经常被灌输不足，向医生和患者展示有关 哪些患者的治疗作用。通过提高效率和质量来解决这些差距 临床试验是临床试验转化计划（CTTI）的总体目的。 自2007年成立以来，CTTI由杜克大学和美国食品和药物管理局结合 （FDA），并由杜克（Duke 临床试验的效率。 CTTI项目通过 专注于质量，相关性和效率。这些问题的示例包括知情同意，主题 招聘，中央机构审查委员会（IRB），调查新药（IND）安全报告， 临床试验质量，操作和监测以及抗菌药物开发，所有这些都是直接的 与FDA的任务相关（附录A：CTTI项目组合）。临床试验包括大量 利益相关者由医学研究所共同确定为临床试验企业（CTE）。所有CTE 利益相关者在CTTI项目中代表，因此可以实施建议并达成共识 关于涵盖质量和效率提高的潜力，可以达到联系。 CTTI的策略 涉及三管齐下的方法：1）临床试验方法和过程的增量改进； 2） 更好地了解国家研究组合，以改善试验与公共卫生的匹配 优先事项； 3）推动变革变革的推动力，它将提供不仅仅是增量改进 （附录B：战略计划）。 CTTI的工作不仅限于建议，还包括创建 工具和其他方法来促进其建议。 该提案的总体目标是双重的： 1）维持可持续的行政和科学基础设施，该基础设施将显示前进的道路 通过利用广泛而透明的公私私人的高质量，高效和有影响力的临床试验 合作伙伴关系（PPP）提供最佳实践和建议，以减少研究障碍 进行临床试验；和 2）随后传播并促进采用发布的建议和调查结果。