A joint industry-sponsored data monitoring committee model for observational, retrospective drug safety studies in the real-world setting.

Atheline Major-PedersenMary Kate McCullenMary Elizabeth SabolOmolara AdetunjiJoseph MassaroAlfred I NeugutJulie Ann SosaAnthony N Hollenberg

Published in: Pharmacoepidemiology and drug safety (2020)

To our knowledge, we have established the first DMC model for joint industry-sponsored, observational, retrospective safety studies. This model could serve as a precedent for others performing similar post-marketing, joint industry-sponsored pharmacovigilance activities.

Keyphrases

cross sectional
healthcare
emergency department
machine learning
case control
deep learning
artificial intelligence