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

Journal Article (Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • Chung, KC; Malay, S; Shauver, MJ; Wrist and Radius Injury Surgical Trial Group,

Published Date

  • December 2019

Published In

Volume / Issue

  • 144 / 6

Start / End Page

  • 1095e - 1103e

PubMed ID

  • 31764675

Pubmed Central ID

  • PMC6905126

Electronic International Standard Serial Number (EISSN)

  • 1529-4242

Digital Object Identifier (DOI)

  • 10.1097/PRS.0000000000006271

Language

  • eng

Conference Location

  • United States