Process guide for inferential studies using healthcare data from routine clinical practice to evaluate causal effects of drugs (PRINCIPLED): considerations from the FDA Sentinel Innovation Center

Authors: Rishi J Desai, Shirley V Wang, Sushama Kattinakere Sreedhara, Luke Zabotka, Farzin Khosrow-Khavar, Jennifer C Nelson, Xu Shi, Sengwee Toh, Richard Wyss, Elisabetta Patorno, Sarah Dutcher, Jie Li, Hana Lee, Robert Ball, Gerald Dal Pan, Jodi B Segal, Samy Suissa, Kenneth J Rothman, Sander Greenland, Miguel A Hernán, Patrick J Heagerty, Sebastian Schneeweiss

Published: 2024-02-12

DOI: 10.1136/bmj-2023-076460

Source: Full article

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Abstract

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