The Complexity of Conducting a Multicenter Clinical Trial: Taking It to the Next Level Stipulated by the Federal Agencies

开展多中心临床试验的复杂性:如何将其提升到联邦机构规定的更高水平

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Abstract

Randomized controlled trials are becoming increasingly difficult to organize and conduct efficiently. This, in turn, hinders the ability to derive the highest level of evidence. Often, investigators forget or remain unaware of essential practices that will help them fulfill their study goals. This article emphasizes the common issues that a study team experiences during the planning and conducting of randomized controlled trials. The authors sought to share remedies to overcome these issues with the experience garnered in conducting several multicenter clinical trials and observational studies. In addition, the authors list resources from sponsors such as the National Institutes of Health and the U.S. Food and Drug Administration that study teams can apply to undertake studies effectively.

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