A national strategy to develop pragmatic clinical trials infrastructure.

Journal Article (Journal Article)

An important challenge in comparative effectiveness research is the lack of infrastructure to support pragmatic clinical trials, which compare interventions in usual practice settings and subjects. These trials present challenges that differ from those of classical efficacy trials, which are conducted under ideal circumstances, in patients selected for their suitability, and with highly controlled protocols. In 2012, we launched a 1-year learning network to identify high-priority pragmatic clinical trials and to deploy research infrastructure through the NIH Clinical and Translational Science Awards Consortium that could be used to launch and sustain them. The network and infrastructure were initiated as a learning ground and shared resource for investigators and communities interested in developing pragmatic clinical trials. We followed a three-stage process of developing the network, prioritizing proposed trials, and implementing learning exercises that culminated in a 1-day network meeting at the end of the year. The year-long project resulted in five recommendations related to developing the network, enhancing community engagement, addressing regulatory challenges, advancing information technology, and developing research methods. The recommendations can be implemented within 24 months and are designed to lead toward a sustained national infrastructure for pragmatic trials.

Full Text

Duke Authors

Cited Authors

  • Concannon, TW; Guise, J-M; Dolor, RJ; Meissner, P; Tunis, S; Krishnan, JA; Pace, WD; Saltz, J; Hersh, WR; Michener, L; Carey, TS

Published Date

  • April 2014

Published In

Volume / Issue

  • 7 / 2

Start / End Page

  • 164 - 171

PubMed ID

  • 24472114

Pubmed Central ID

  • PMC4126802

Electronic International Standard Serial Number (EISSN)

  • 1752-8062

Digital Object Identifier (DOI)

  • 10.1111/cts.12143


  • eng

Conference Location

  • United States