Co-Chairs: Jeff Brown, Lesley Curtis
Advisor: Richard Platt
NIH Representative: Barbara Wells
Members: Nick Anderson, Alan Bauck, Pedro Gozalo, Katherine Haffenreffer, Gene Hart, Susan Huang, Brett Moran, Jon Puro, Erik Van Eaton, Ferdinand Velasco, Wolfgang Winkelmayer
Project Manager: Beth Syat
The ability to harness electronic health data is transforming the way clinical research is conducted. The Electronic Health Records (EHR) Core’s goal is to facilitate multisite research collaborations between investigators and data stewards by creating secure networking capabilities and analysis tools. The Core also develops policies and practices to govern the responsible use of these resources.
The EHR Core has established the NIH Collaboratory Distributed Research Network (DRN), which will allow investigators to collaborate in the use of clinical data while safeguarding protected health information and proprietary data. The DRN will enable authorized researchers to send queries to collaborators. In some cases, queries are computer programs that a data partner can execute on a pre-existing dataset. The data partner can return the query result, rather than the actual data. This form of remote querying reduces legal, regulatory, privacy, proprietary, and technical barriers associated with data sharing for research.
By facilitating knowledge exchange without requiring a massive data warehousing effort, the DRN combines local control and security with the power that can be achieved from large datasets. All data queries are opt-in; in other words, data partners can choose whether to accept a query and execute it.
The DRN uses the PopMedNet software application and complies with the standards for distributed querying supported by the Office of the National Coordinator for Health Information Technology’s Query Health Initiative and adopted by other research collaborations, including Mini-Sentinel. The DRN supports both single-site and multisite research projects.
Its capabilities include the following:
Assessing disease burden and outcomes
- Estimate the frequency of conditions or patterns of care
- Example: determine frequency and duration of insulin pump use and characterize the individuals who use them
|Pragmatic clinical trial design
- Assess baseline rate of events of interest
- Identify organizations with enough potential study participants
- Identify potential study participants within an organization
|Pragmatic clinical trial follow-up
- Scan electronic data of study participants for outcomes of interest
- Examples: prescription medications dispensed, inpatient and ambulatory medical encounters
- Information may include medications, dates, diagnoses, procedures, etc.
|Allowing reuse of research data
- An investigator who has created a clinically rich research dataset can authorize an investigator at another organization to submit analytic programs
- Depending on the analysis, the output need not contain patient identifiers
|Establishing a private network for a multicenter study
- The Collaboratory Coordinating Center can establish a private distributed network to send out programs that create separate analysis files at each site
- Analysis files are securely transferred to the analyst
For more information on the NIH Collaboratory DRN and the process for submitting queries, visit the DRN website.