Building capacity for clinical trial improvement through implementation science

项目总结 每年，癌症中心投资数百万美元用于“校内试验”--资助的机构临床试验 以补充更大规模的合作小组、行业和NIH资助的试验。虽然临床试验有所改善 患者护理和先进的科学，我们的研究表明，五分之一的临床试验未能达到预期 还有1/3的人没有达到注册目标。这些失败率似乎更高 规模较小的单中心(即更有可能是内部试验)试验。除了识别过去的故障率之外， 缺乏改善试验实施的可操作的见解，让患者和科学都失望了。在一部小说中 应用实施科学方法，我们打算通过调整现有的 临床试验背景下的方法学。这种创新的方法认为临床试验是复杂的。 执行不力的干预措施。这将为研究和提高科学提供一个平台 和临床试验的实践。在普罗科特实施成果的指导下，我们将召开一个小组会议， 利益相关者定义内部临床试验的实施和其他结果。这一方法将 提供机构和调查人员的观点，以提供内部审判的概念模型 实施和成功。我们还将确定内科临床试验结果的决定因素。 通过运用综合框架实施研究，深入定性分析 校内临床试验。通过这项研究，我们将在可管理的范围内开发基本方法 试验企业的模式，为内部计划提供有价值的见解，并指导未来 系统的调查和改进工作。

PROJECT SUMMARY Each year, cancer centers invest millions of dollars into “intramural trials”—institutional clinical trials funded to complement larger scale cooperative group, industry, and NIH-funded trials. While clinical trials improve patient care and advance science, our research shows 1 in 5 clinical trials fail to reach their anticipated endpoints, and an additional 1 in 3 do not reach enrollment goals. These failure rates appear higher for smaller and single-center (i.e., more likely intramural) trials. Other than identifying past failure rates, actionable insights to improve trial implementation are lacking, failing both patients and science. In a novel application of implementation science methods, we intend to address this clear gap by adapting existing methodology to the clinical trials context. This innovative approach considers clinical trials as complex interventions with poor implementation. This will provide a platform to study and improve both the science and practice of clinical trials. Guided by Proctor’s implementation outcomes, we will convene a panel of stakeholders to define implementation and other outcomes for intramural clinical trials. This approach will provide institutional and investigator perspectives to inform a conceptual model of intramural trial implementation and success. We will additionally identify determinants of intramural clinical trial outcomes by using the Consolidated Framework for Implementation Research for in-depth and qualitative analysis of intramural clinical trials. Through this study, we will develop foundational methods within a manageable model of the trials enterprise to provide valuable insights to intramural programs and guide future systematic investigation and improvement efforts.