Kost Rhonda G, Devine Rita K, Fernands Mark, Gottesman Riva, Kandpal Manoj, MacArthur Robert B, O'Sullivan Barbara, Romanick Michelle, Ronning Andrea, Schlesinger Sarah, Tobin Jonathan N, Vaughan Roger, Neville-Williams Maija, Krueger James G, Coller Barry S
Center for Clinical and Translational Science, Rockefeller University, New York, NY, USA.
Clinical Directors Network, Inc. (CDN), New York, NY, USA.
J Clin Transl Sci. 2023 Apr 13;7(1):e104. doi: 10.1017/cts.2023.521. eCollection 2023.
Clinical trials are a vital component of translational science, providing crucial information on the efficacy and safety of new interventions and forming the basis for regulatory approval and/or clinical adoption. At the same time, they are complex to design, conduct, monitor, and report successfully. Concerns over the last two decades about the quality of the design and the lack of completion and reporting of clinical trials, characterized as a lack of "informativeness," highlighted by the experience during the COVID-19 pandemic, have led to several initiatives to address the serious shortcomings of the United States clinical research enterprise.
Against this background, we detail the policies, procedures, and programs that we have developed in The Rockefeller University Center for Clinical and Translational Science (CCTS), supported by a Clinical and Translational Science Award (CTSA) program grant since 2006, to support the development, conduct, and reporting of informative clinical studies.
We have focused on building a data-driven infrastructure to both assist individual investigators and bring translational science to each element of the clinical investigation process, with the goal of both generating new knowledge and accelerating the uptake of that knowledge into practice.
临床试验是转化科学的重要组成部分，提供有关新干预措施疗效和安全性的关键信息，并构成监管批准和/或临床应用的基础。与此同时，成功设计、开展、监测和报告临床试验非常复杂。过去二十年来，对临床试验设计质量以及临床试验缺乏完整性和报告情况（被称为缺乏“信息性”）的担忧，在新冠疫情期间的经历中凸显出来，这引发了多项举措来解决美国临床研究企业的严重缺陷。
在此背景下，我们详细介绍了自2006年以来在洛克菲勒大学临床与转化科学中心（CCTS）制定的政策、程序和计划，该中心由临床与转化科学奖（CTSA）项目资助，以支持开展信息丰富的临床研究并进行报告。
我们专注于构建一个数据驱动的基础设施，以协助个体研究人员，并将转化科学应用于临床研究过程的每个环节，目标是既产生新知识，又加速将该知识应用于实践。
