第三阶段临床试验人员实施科学指南》:设计试验,促进证据吸收

IF 21.7 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Harriette G.C. Van Spall MD , Laura Desveaux PhD , Tracy Finch PhD , Cara C. Lewis PhD , George A. Mensah MD , Yves Rosenberg MD , Kavita Singh PhD , Francois Venter PhD , Bryan J. Weiner PhD , Faiez Zannad MD
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引用次数: 0

摘要

心血管疾病临床试验后,循证治疗方法的采用被延迟,且效果一般,这突出表明在治疗方法的开发和测试早期,需要更加关注实施问题。然而,人们对实施科学并不十分了解,往往在第三阶段试验后才想到实施科学。在本综述中,我们介绍了实施科学的目标、框架和方法,以及实施过程中常见的多层次障碍和促进因素。我们建议,在试验结束后实施的一些方法可以纳入第三阶段试验的设计中,以促进试验后的早期实施。这些方法包括但不限于: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;使用限制性较小的资格标准,确保内部有效性和可推广性;由监管机构对试验方案进行审查;将试验执行与医疗保健系统相结合;评估和解决干预措施实施过程中的障碍和促进因素;以及在不同辖区进行成本效益和成本效用分析。我们提供了案例,以突出概念并指导试验结束后的实施。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A Guide to Implementation Science for Phase 3 Clinical Trialists
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.
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来源期刊
CiteScore
42.70
自引率
3.30%
发文量
5097
审稿时长
2-4 weeks
期刊介绍: The Journal of the American College of Cardiology (JACC) publishes peer-reviewed articles highlighting all aspects of cardiovascular disease, including original clinical studies, experimental investigations with clear clinical relevance, state-of-the-art papers and viewpoints. Content Profile: -Original Investigations -JACC State-of-the-Art Reviews -JACC Review Topics of the Week -Guidelines & Clinical Documents -JACC Guideline Comparisons -JACC Scientific Expert Panels -Cardiovascular Medicine & Society -Editorial Comments (accompanying every Original Investigation) -Research Letters -Fellows-in-Training/Early Career Professional Pages -Editor’s Pages from the Editor-in-Chief or other invited thought leaders
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