A National Strategy to Develop Pragmatic Clinical Trials Infrastructure

Thomas W. Concannon, Jeanne Marie Guise, Rowena J. Dolor, Paul Meissner, Sean Tunis, Jerry A. Krishnan, Wilson D. Pace, Joel Saltz, William R. Hersh, Lloyd Michener, Timothy S. Carey

Research output: Contribution to journalArticlepeer-review

18 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)164-171
Number of pages8
JournalClinical and Translational Science
Issue number2
StatePublished - 2014
Externally publishedYes


  • Ethics
  • Methodology
  • Translational research
  • Trials

ASJC Scopus subject areas

  • General Medicine
  • General Biochemistry, Genetics and Molecular Biology
  • General Neuroscience
  • Pharmacology, Toxicology and Pharmaceutics(all)


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