Multi-Site Methods and Coordination

Large-scale pharmacoepidemiologic research often requires collaboration across multiple healthcare systems and data environments. Our team designs and coordinates multi-site studies that leverage distributed health data networks to generate rigorous real-world evidence on the safety, effectiveness, and use of medical products.

Distributed Data Network Approach

Our multi-site studies are modeled after the methods, resources and partners we developed through our leadership of the FDA Sentinel Initiative. In this model, standardized analytic programs are distributed to participating research and data partners and executed locally within secure data environments.

The Distributed Data Advantage

Compared with traditional common protocol approaches, where each site independently conducts analyses, distributed programming improves consistency, reduces variability in analytic implementation, and strengthens quality assurance across sites. This approach also avoids redundant effort.

Distributed networks also provide advantages over centralized data aggregation. Because data remain under the control of local institutions, the model supports stronger privacy protections, more flexible governance, and the ability to include partners who cannot share patient-level data externally.

Together, these advantages enable large-scale research while preserving the privacy, security, and stewardship of healthcare data.

Sentinel Initiative Methods

Many of the methods used in our multi-site studies have been developed and refined through our leadership of the Sentinel Initiative, a national distributed data network established by the U.S. Food and Drug Administration to monitor the safety of medical products.

The Sentinel System has helped advance methods for distributed data analysis, active safety surveillance, and large-scale observational studies using healthcare data. These methodological foundations inform the design and execution of many of the multi-site studies conducted by our team.

About Sentinel methods and infrastructure

Large-Scale Data and Quality Assurance

Ensuring the reliability of evidence generated from distributed data sources requires careful data standardization, governance, and quality assessment. We work closely with data partners to harmonize data structures, evaluate data quality, and implement analytic programs that produce consistent results across participating sites.

This approach allows researchers to conduct large-scale studies while maintaining rigorous standards for data integrity and analytic reproducibility.

Research Highlights

Our investigators have contributed to a wide range of multi-site studies evaluating the safety and effectiveness of medical products using large healthcare data networks. These studies include collaborative research on vaccine safety surveillance, drug safety signal detection, and the evaluation of medical product outcomes across diverse populations.

Post-authorizationsafety study to assess the risk of diabetic ketoacidosis among type 2 diabetesmellitus patients treated with ertugliflozin compared to patients treated withother antihyperglycemic agents in a Medicare and Medicaid population

Published in Diabetic Medicine

Authors: Rai A, Marshall J, Nandyala S, Her M, Agan AA, Huang TY, Rodriguez-Watson C, Clary A, Diessner B, Nolan MB, Djibo DA, DeVries A, Daniels K, Zhang X, Wang T, Gantz I, Shankar R, Zale MM, Ejelonu P, Frederich R, Masiukiewicz U, Toh S

December 15, 2025

Interim Safety of RSVpreF Vaccination During Pregnancy

Published in Journal of the American Medical Association (JAMA)

Authors: Michnick AI, MacDonald SC, Cosgrove A, Adimadhyam S, Zhang F, Petrone AB, Round KE, Gandhi S, Koram N, Anastasiou OE, Rubino H, Lino MM, Djibo DA, Kuntz JL, Love SM, McMahill-Walraven CN, Palmsten K, Wentz AE, Maro JC, Platt R, Andrade SE

February 3, 2026

Explore Publications

Explore our full publication library to learn more about the studies and methods that inform our work.