Summary
The NIH sought an effective clinical informatics (CI) strategic plan to reduce costs, create scalable innovations in treatment discovery, facilitate oversight, and advance the understanding of human diseases.
As one of the largest clinical research hospitals in the country, the NIH Clinical Center is conducting ~1,500 clinical studies and manages a growing volume of clinical research data, and wants to ensure it is secure, actionable, and FAIR, while automating data movement and integrating the various software and database systems used in clinical studies.
A lack of strategic organization of CI systems and datasets across the Intramural Research Program (IRP) hinders the implementation and reporting of clinical studies, clinical care, and the secondary reuse of clinical study data. By creating a CI strategic roadmap, BioTeam helped to simplify oversight and increase the FAIRness (findable, accessible, interoperable, and reusable) of data, increasing efficiency and reducing research redundancy.
Services provided:
- Strategic Planning & Organizational Enablement
- Data Management by conducting technical reviews and evaluations
- Design & Implementation within Data Management by building a CDW and clinical study dashboard prototype.
Challenges
Similar to many pharmaceutical companies, the NIH Intramural Research Program (IRP) manages large volumes of clinical research data across many independent systems. This fragmented environment made it difficult to ensure that data were secure, accessible, and FAIR (findable, accessible, interoperable, reusable). Investigators faced challenges in planning and executing studies, as well as integrating data across platforms and reusing study data efficiently. NIH needed a coordinated informatics strategy to address these issues and reduce redundancy across its clinical research portfolio.
Approach
BioTeam worked with NIH to develop a comprehensive strategic plan for clinical informatics through a multi-phase process. Activities included:
- Conducting an NIH-wide assessment of clinical informatics systems and practices across Institutes and Centers
- Interviewing investigators and clinical staff to identify pain points and requirements for study planning, execution, and data reuse
- Reviewing informatics architectures and comparing them with practices at leading academic medical centers
- Defining use cases that mapped current-state challenges to desired improvements in the research lifecycle
This evidence-based approach informed a clear vision for the future of clinical informatics at NIH and guided development of the five-year strategic plan.
Outcomes
The project delivered a five-year Clinical Research Informatics Strategic Plan for the NIH Intramural Research Program. Key outcomes included:
- Technical reviews of existing informatics architectures and platforms
- Resource estimates to support the implementation of a harmonized informatics environment
- Definition of a future-state model for clinical research, centered on a clinical data warehouse (CDW)
- Design and initial implementation of prototypes for a CDW and a clinical study dashboard using dbGaP data
These outputs provided NIH with a practical roadmap to modernize clinical informatics, improve data integration, and enable more efficient and secure reuse of clinical study data across the Intramural Research Program.
