Strengthening inferential studies in the FDA Sentinel initiative: results from a methodological demonstration project
Rishi J Desai, Janick Weberpals, Haritha Pillai, Adebola Ajao, Mukund Desibhatla, Rebecca Hawrusik, José J Hernández-Muñoz, Chanelle Jones, Jamal T Jones, Joyce Lii, Jie Li, Jennifer G Lyons, Ryan Schoeplein, Fatma M Shebl, Sengwee Toh, Elisabetta Patorno, Sebastian Schneeweiss · 2025
Read Strengthening inferential studies in the FDA Sentinel initiative: results from a methodological demonstration project by Rishi J Desai, Janick Weberpals, Haritha Pillai, Adebola Ajao, Mukund Desibhatla, Rebecca Hawrusik, José J Hernández-Muñoz, Chanelle Jones, Jamal T Jones, Joyce Lii, Jie Li, Jennifer G Lyons, Ryan Schoeplein, Fatma M Shebl, Sengwee Toh, Elisabetta Patorno, Sebastian Schneeweiss (2025) in the Tower of Babel, a free online library of public-domain works preserved in clean, searchable text. No sign-up. The full text is served as a plain-text file at a predictable URL, where text is present: https://antarctic-labs.com/tower-of-babel/pmc-12816695.txt.
Description
Rishi Desai and a large team of co-authors reported a 2025 project that tested a federal drug safety network. The network now links health records with claims data for more than twenty-five million patients. To prove the linked data can support firm studies, the team copied the design of a trial that claims data alone could not handle. Their test case compared two diabetes drug types and a pancreas side effect.
The study covered 97,119 people with type 2 diabetes from two large databases. A checked computer method flagged cases of pancreas swelling from the records. After adjusting for more than 135 factors, one drug group showed a slightly lower risk than the other, though the gap was not firm. The authors call the work a proof of concept for future safety checks.
Catalog record
| CREATOR | Rishi J Desai, Janick Weberpals, Haritha Pillai, Adebola Ajao, Mukund Desibhatla, Rebecca Hawrusik, José J Hernández-Muñoz, Chanelle Jones, Jamal T Jones, Joyce Lii, Jie Li, Jennifer G Lyons, Ryan Schoeplein, Fatma M Shebl, Sengwee Toh, Elisabetta Patorno, Sebastian Schneeweiss |
|---|---|
| YEAR | 2025 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 35 KB |
| VERSION | 1.0 |
| LICENSE | CC BY 4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |