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

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.
Competing Interests: This work is supported within the National Institutes of Health (NIH) Health Care Systems Research Collaboratory by the NIH Common Fund through cooperative agreement U24AT009676 from the Office of Strategic Coordination within the Office of the NIH Director. The views presented here are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health. JB, BH and RP have no conflicts of interest to disclose; BS reports grants from NIH during the conduct of the study; KM reports grants from PCORI, during the conduct of the study; personal fees from Novartis, outside the submitted work; AH reports grants and personal fees from AstraZeneca, grants and personal fees from Bayer, personal fees from Boehringer Ingelheim, grants from American Regent, grants and personal fees from Novartis, grants and personal fees from Merck, grants from Verily, outside the submitted work; LC reports grants from GlaxoSmithKline, grants from Novartis, grants from Boston Scientific, from St. Jude, outside the submitted work; SR reports grants from GSK, outside the submitted work. There are no other financial relationships with any organisations that might have an interest in the submitted work in the previous three years and no other relationships or activities that could appear to have influenced the submitted work.
(© 2019 Published by Elsevier Inc.)