Efficiency of eSource Direct Data Capture in Investigator-Initiated Clinical Trials in Oncology

Abstract

Abstract Background Clinical trials have become larger and more complex. Thus, eSource should be used to enhance efficiency. This study aimed to investigate the impact of using direct data capture (eSource DDC) using electronic case report forms as source data on the efficiency of a late-phase, multicenter, investigator-initiated clinical trial in oncology. Methods Source data identification list, electronic data capture (EDC) database structure specifications, audit trails output from EDC, and monitoring reports were used to analyze varying collection items of DDC at each site, time from data occurrence to data entry and data finalization, and number of visits to the site and time spent at the site by clinical research associates (CRAs). Additionally, simulations were performed on the change in hours at the clinical sites during the implementation of eSource DDC. Results The percentage of fields with DDC was 61.9–84.5%, indicating variations across sites. The forms commonly defined as DDC for all sites tended to be initially entered by clinical research coordinators. No difference in time from data occurrence to data entry was observed between the DDC and the transcribed data fields. However, the DDC fields could be finalized 4 days earlier than the non-DDC fields. Additionally, although no difference was observed in the number of visits for source data verification (SDV) by CRAs, a comparison between sites that introduced eSource DDC and those that did not showed that the time spent at the site for SDV was reduced. Furthermore, the simulation results indicated that even a small amount of data to be collected or a small percentage of DDC-capable items may lead to greater efficiency when the number of subjects per site is significant. Conclusions The implementation of eSource DDC may enhance efficiency, depending on the study framework and the type and number of items to be collected.