Considerations for using distributed research networks to conduct aspects of randomized trials.

Published online

Journal Article

Stakeholders in the clinical research enterprise are aligned around the need to make clinical research in general, and randomized controlled trials in particular, more meaningful and efficient. To that end, we have built distributed research networks (DRNs) for the Sentinel System, the National Institutes of Health (NIH) Collaboratory, and the National Patient-Centered Clinical Research Network (PCORnet). DRNs reuse electronic health record (EHR) and claims data for research. The design and use of health data DRNs is complicated by lack of uniformity in data collection, a fragmented healthcare system, and the imperative to protect research participants. We describe the key elements of successful DRNs, as well as methods, challenges, and solutions we have encountered in using DRNs to support different phases of randomized, multi-site, clinical research. This work supports "real-world" efforts to build a learning health system and will enable others to conduct randomized clinical trial research using a DRN.

Full Text

Duke Authors

Cited Authors

  • Marsolo, KA; Brown, JS; Hernandez, AF; Hammill, BG; Raman, SR; Syat, B; Platt, R; Curtis, LH

Published Date

  • March 2020

Published In

Volume / Issue

  • 17 /

Start / End Page

  • 100515 -

PubMed ID

  • 31956724

Pubmed Central ID

  • 31956724

Electronic International Standard Serial Number (EISSN)

  • 2451-8654

Digital Object Identifier (DOI)

  • 10.1016/j.conctc.2019.100515

Language

  • eng

Conference Location

  • Netherlands