Towards clinical data-driven eligibility criteria optimization for interventional COVID-19 clinical trials.

ABSTRACT:

Objective

This research aims to evaluate the impact of eligibility criteria on recruitment and observable clinical outcomes of COVID-19 clinical trials using electronic health record (EHR) data.

Materials and methods

On June 18, 2020, we identified frequently used eligibility criteria from all the interventional COVID-19 trials in ClinicalTrials.gov (n = 288), including age, pregnancy, oxygen saturation, alanine/aspartate aminotransferase, platelets, and estimated glomerular filtration rate. We applied the frequently used criteria to the EHR data of COVID-19 patients in Columbia University Irving Medical Center (CUIMC) (March 2020-June 2020) and evaluated their impact on patient accrual and the occurrence of a composite endpoint of mechanical ventilation, tracheostomy, and i

SUBMITTER: Kim JH 

PROVIDER: S-EPMC7798960 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature