To address the Real-World Evidence (RWE) Data Enterprise mandate, the FDA has tasked the Sentinel Innovation Center (IC) and Sentinel Operations Center (SOC) with establishing a query-ready, quality-checked distributed data network containing electronic health records (EHRs) for at least 10 million lives with reusable analysis tools. A key first step in establishing such a network is identifying and assessing potential partners that could contribute the necessary data for this system. This includes existing data, expansion, innovation partners, and data sources not currently included in Sentinel.
The purpose of this project is twofold:
In the first phase of this project, the workgroup aims to develop and implement a horizon scan and series of interviews to:
- Identify EHR sources and registries
- Conduct initial feasibility assessments of these potential partners for enhancing the Sentinel System
At the end of Phase 1, the workgroup will produce a report describing the search and its findings, along with a prioritized list of potential EHR sources for empirical querying.
In the second phase of this project, the workgroup aims to conduct empirical queries in three of the most promising EHR databases identified and recommended from phase 1. These queries will be used to inform planning of the data expansion process and will be designed to:
- Better understand the data available from each potential partner
- Evaluate the potential partners’ processes and readiness to perform the queries
- Identify potential barriers to integrating the potential partners into the Sentinel System
The horizon scan will ensure a thorough search of US EHR resources with a particular focus on identifying and evaluating potential sources of data on pediatric, cancer, and pregnancy/birth outcomes, as well as cause of death data. Furthermore, the horizon scan will consider EHR data sources that will be useful to address questions related to future COVID-like outbreaks.
Rishi Desai, MS, PhD; Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA
Jeffery Brown, PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Keith Marsolo, PhD; Duke Clinical Research Institute, Durham, NC
Michael Matheny, MD, MS, MPH; Vanderbilt University Medical Center, Department of Biomedical Informatics, Nashville, TN
Joshua Gagne, PharmD, ScD; Shamika More, MS; Sebastian Schneeweiss, MD, ScD; Winnie Ho, BA; Luke Zabotka, BA; Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA
David Carrell, PhD; Kaiser Permanente Washington Health Research Institute, Seattle, WA
Adee Kennedy, MS, MPH; Jennifer Lyons, PhD; Mayura Shinde, DrPH, MPH; Sheryl Kluberg, PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Jie (Jenni) Li, PhD; Catherine Lerro, PhD; Catherine Corey, MSPH; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD