Name
#164 Leveraging Standardized Informatics Tools for Clinical Trials Research Across the NIH: Opportunities for Resource Sharing, Efficiency and Data Harmonization
Content Presented On Behalf Of:
Uniformed Services University
Session Type
Poster
Date
Tuesday, March 3, 2026
Start Time
5:00 PM
End Time
7:00 PM
Location
Prince Georges Expo Hall E
Focus Areas/Topics
Technology
Learning Outcomes
Following this session, the attendee will be able to: (1) Understand the importance of data harmonization standards in clinical trials research (2) Summarize the advantages of government owned and managed solutions in providing cost efficiency and sustainability (3) Describe the importance of leveraging inter agency collaborations
Session Currently Live
Description
The goal of clinical trials research is to address gaps within existing treatments through the development of new drugs, devices or therapies. The nature of clinical trials have changed with increasingly large and diverse amounts of data from varying sources (sensors, devices, patient assessments, etc.). The use of digital tools such as electronic data collection systems have provided efficiencies in data collection and management. However, many of these tools are often siloed without adherence to clear data standards, leading to significant complications and burden with data analysis, harmonization, and management. We have developed a standardized informatics platform through the National Institutes of Neurological Diseases and Stroke (NINDS) called the Clinical Information System for Trials And Research (CiSTAR) platform. At the core, the CiSTAR platform is built on the NIH BRICS system however, there are several important integrated tools for clinical trials: full audit capabilities, biospecimen tracking and management, offline capture, remote data collection, integrated patient management, adverse event reporting, data dictionary and real-time data access to support user friendly informatics capabilities. The CiSTAR platform is able to manage research protocol setup, ingest data collected externally, manage subjects, facilitate regulatory compliance and end-to-end support of the clinical trials lifecycle (planning to execution to close-out). In addition, inbuilt API end-points available in the CiSTAR platform provide opportunity for data analysis using individual computers or the ability to seamless scale up via integration with cloud pipelines for analytics and Artificial Intelligence (AI) or Machine Learning (ML) analysis. The CiSTAR platform has been successfully deployed to support a variety of active NINDS intramurally funded clinical trials, and collaborative support for other institutes such as the National Institutes of Mental Health, National Institute of Cancer, etc. This platform is also integrated with the electronic health records system at the NIH wherein researchers are able to seamlessly extract information from medical records, labs, assessments and also the electronic Internal Review Board system to obtain protocol information into the CiSTAR platform. The practical development and implementation of a standardized informatics platform is valuable as it provides explicit process for data regulatory compliance, monitoring, curation and sharing, with a well-documented data dictionary; features that promote data sharing and serve to accelerate translational therapeutics and cross validation of research findings. In addition the architecture of the CiSTAR platform offers resource efficiencies and reduces management costs and burden. Lastly, a government owned solution that is locally hosted and managed provides efficiency, scalability and sustainability for processes, resources and data ownership.