The delayed and modest uptake of evidence-based treatments following cardiovascular clinical trials highlights the need for greater attention to implementation early in the development and testing of treatments. However, implementation science is not well understood and is often an afterthought following phase 3 trials. In this review, we describe the goals, frameworks, and methods of implementation science, along with common multilevel barriers and facilitators of implementation. We propose that some of the approaches used for implementation well after a trial has ended can be incorporated into the design of phase 3 trials to foster early post-trial implementation. Approaches include, but are not limited to, engaging broad stakeholders including patients, clinicians, and decision-makers in trial advisory boards; using less restrictive eligibility criteria that ensure both internal validity and generalizability; having trial protocols reviewed by regulators; integrating trial execution with the health care system; evaluating and addressing barriers and facilitators to deployment of the intervention; and undertaking cost-effectiveness and cost utility analyses across jurisdictions. We provide case examples to highlight concepts and to guide end-of-trial implementation.

中文翻译：

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3 期临床试验员实施科学指南：设计证据吸收试验


心血管临床试验后循证治疗的延迟和适度采用凸显了在治疗开发和测试的早期更加关注实施的必要性。然而，实施科学并不被很好地理解，并且通常是在 3 期试验之后才想到的。在这篇综述中，我们描述了实施科学的目标、框架和方法，以及常见的多层次障碍和实施促进因素。我们建议，一些用于在试验结束后实施的方法可以纳入 3 期试验的设计中，以促进试验后的早期实施。方法包括但不限于：让包括患者、临床医生和决策者在内的广泛利益相关者参与试验咨询委员会;使用限制较少的资格标准，确保内部有效性和普遍性;让监管机构审查试验方案;将试验执行与医疗保健系统相结合;评估和解决部署干预措施的障碍和促进因素;以及跨司法管辖区进行成本效益和成本效用分析。我们提供了案例示例来突出概念并指导试用期结束实施。