Creation of an ustekinumab external control arm for Crohn's disease using electronic health records data: A pilot study.

ABSTRACT:

Background

Randomized trials are the gold-standard for clinical evidence generation, but they can sometimes be limited by infeasibility and unclear generalizability to real-world practice. External control arm (ECA) studies may help address this evidence gaps by constructing retrospective cohorts that closely emulate prospective ones. Experience in constructing these outside the context of rare diseases or cancer is limited. We piloted an approach for developing an ECA in Crohn's disease using electronic health records (EHR) data.

Methods

We queried EHR databases and manually screened records at the University of California, San Francisco to identify patients meeting the eligibility criteria of TRIDENT, a recently completed interventional trial involving an ustekinumab refer

SUBMITTER: Rudrapatna VA 

PROVIDER: S-EPMC9980824 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature