Leveraging electronic health record data for clinical trial planning by assessing eligibility criteria's impact on patient count and safety.

ABSTRACT:

Objective

To present an approach on using electronic health record (EHR) data that assesses how different eligibility criteria, either individually or in combination, can impact patient count and safety (exemplified by all-cause hospitalization risk) and further assist with criteria selection for prospective clinical trials.

Materials and methods

Trials in three disease domains - relapsed/refractory (r/r) lymphoma/leukemia; hepatitis C virus (HCV); stages 3 and 4 chronic kidney disease (CKD) - were analyzed as case studies for this approach. For each disease domain, criteria were identified and all criteria combinations were used to create EHR cohorts. Per combination, two values were derived: (1) number of eligible patients meeting the selected criteria; (2) hospitalization

SUBMITTER: Rogers JR 

PROVIDER: S-EPMC8920749 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature