Pragmatic (trial) informatics: a perspective from the NIH Health Care Systems Research Collaboratory.

Journal Article (Journal Article)

Pragmatic clinical trials (PCTs) are research investigations embedded in health care settings designed to increase the efficiency of research and its relevance to clinical practice. The Health Care Systems Research Collaboratory, initiated by the National Institutes of Health Common Fund in 2010, is a pioneering cooperative aimed at identifying and overcoming operational challenges to pragmatic research. Drawing from our experience, we present 4 broad categories of informatics-related challenges: (1) using clinical data for research, (2) integrating data from heterogeneous systems, (3) using electronic health records to support intervention delivery or health system change, and (4) assessing and improving data capture to define study populations and outcomes. These challenges impact the validity, reliability, and integrity of PCTs. Achieving the full potential of PCTs and a learning health system will require meaningful partnerships between health system leadership and operations, and federally driven standards and policies to ensure that future electronic health record systems have the flexibility to support research.

Full Text

Duke Authors

Cited Authors

  • Richesson, RL; Green, BB; Laws, R; Puro, J; Kahn, MG; Bauck, A; Smerek, M; Van Eaton, EG; Zozus, M; Hammond, WE; Stephens, KA; Simon, GE

Published Date

  • September 1, 2017

Published In

Volume / Issue

  • 24 / 5

Start / End Page

  • 996 - 1001

PubMed ID

  • 28340241

Pubmed Central ID

  • PMC6916747

Electronic International Standard Serial Number (EISSN)

  • 1527-974X

Digital Object Identifier (DOI)

  • 10.1093/jamia/ocx016


  • eng

Conference Location

  • England