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

Vivek Ashok RudrapatnaYao-Wen ChengColin J FeuilleArman MoseniaJonathan ShihYongmei ShiOlivia RobersonBenjamin RubinAtul J ButteUma MahadevanNicholas SkomrockNgozi EronduChristel ChehoudSaquib RahimDavid ApfelMark CurranNajat S KhanChristopher O'BrienNatalie TerryBenjamin D Martini

Published in: PloS one (2023)

We piloted an approach for creating an ECA in Crohn's disease from EHR data by using a combination of informatics and manual methods. However, our study reveals significant missing data when standard-of-care clinical data are repurposed. More work will be needed to improve the alignment of trial design with typical patterns of clinical practice, and thereby enable a future of more robust ECAs in chronic diseases like Crohn's disease.

Keyphrases

electronic health record
clinical decision support
big data
clinical practice
adverse drug
healthcare
randomized controlled trial
machine learning
deep learning
phase iii
open label
pain management