The Sentinel Innovation Center is a test bed to identify, develop, and evaluate innovative methods to study drug safety and effectiveness using real-world data. The IC was created in response to FDA’s Medical Data Enterprise Initiative to build a new system containing electronic health records from 10 million lives and the Sentinel Five-Year Strategy. Achieving this vision requires:
- Developing new analysis tools for unstructured EHR data
- Establishing novel data sources by finding new ways to extract, standardize and quality check clinical data and free-text in EHRs
- Creating state-of-the-art approaches to identify clinical phenotypes, extract key data elements and adjust for confounding in drug safety and effectiveness studies
Leadership
Structure
Lead Hubs
The IC has four Lead Hubs. These four hubs make up the Executive Leadership Team. Below are the four Lead Hubs in the Executive Leadership Team.
- Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, and Harvard Medical School
- Duke University School of Medicine
- Kaiser Permanente Washington Health Research Institute with the University of Washington School of Public Health
- Vanderbilt University Medical Center Department of Biomedical Informatics
Advisory Board
The Advisory Committee supports the Lead Hubs. The Advisory Committee provides strategic guidance to the IC. It comprises top thought leaders in healthcare innovation. This includes academia, government, and industry.
Innovation Cores
The Innovation Cores identify novel technologies that could lead to new innovation projects.
Innovation Partners and the National Network of Innovation Experts
Innovation Partners are industry leaders in technology innovation.
The National Network of Innovation Experts also works with the Innovation Cores. It comprises individuals in academic and other research settings. They have expertise in various domains of methods, innovation, and technology.
Together, these two groups lead and support projects within the IC. They are innovators and pioneers in:
- data science
- pharmacoepidemiology
- biostatistics
- biomedical informatics
- natural language processing
- machine learning and other areas of artificial intelligence
- signal detection
- advanced causal inference methods
- data linkage and integration
- pragmatic trials
- real-world evidence generation
Below is a list of Advisory Committee members, Innovation Partners, and National Network of Innovation Experts.
- Aetion
- Aetna, a CVS Health company
- Amazon Web Services
- American Medical Informatics Association
- Columbia University
- ConcertoAI
- CorEvitas
- Doc.ai
- Duke Margolis Center for Health Policy
- Duke University
- Epic
- Evidation
- Harvard T.H. Chan School of Public Health
- HealthCore
- HealthVerity
- Humana, Inc.
- Kaiser Permanente Colorado Institute for Health Research
- Mass General Brigham
- Medical University of South Carolina
- Microsoft Healthcare NExT
- Microsoft Research
- Northeastern University
- Oak Ridge National Laboratory
- Observational Health Data Sciences and Informatics (OHDSI)
- Optum Labs
- Optum Life Sciences
- Penn State University
- Putnam Data Sciences
- PRACnet (Humana)
- Rutgers University: Center for Health Services Research
- Stanford University
- STAR Clinical Research Network
- TriNetX
- University of Alabama at Birmingham: Center for Outcomes and Effectiveness Research and Education
- University of California, Berkeley
- University of Illinois at Chicago: Department of Pharmacy Systems, Outcomes and Policy
- University of Iowa: Department of Epidemiology in the College of Public Health
- University of Florida College of Pharmacy: Department of Pharmaceutical Outcomes & Policy
- University of Michigan Medical School
- University of Pennsylvania School of Medicine: Center for Clinical Epidemiology and Biostatistics and Department of Biostatistics, Epidemiology and Informatics
- University of Pittsburgh School of Medicine: Department of Biomedical Informatics
- University of Tennessee
- University of Utah
- Veradigm
Objectives
The Innovation Center was created to attract new data partnerships, engage external investigators to develop new methods, and grow the types of questions that can be addressed in the Sentinel System.
The IC has developed a scientific blueprint for the next five years, named the IC Master Plan. The Master Plan has four key strategic priority areas:
- Data infrastructure
- Feature engineering
- Causal inference
- Detection analytics
The first two priority areas help to establish a query-ready distributed data network containing electronic health records. The second two priorities help develop and evaluate new methods that can be transformed into reusable analytic tools.
