Secondary use of routinely collected patient data in a clinical trial: An evaluation of the effects on patient recruitment and data acquisition

Purpose: Clinical trials are time-consuming and require constant focus on data quality. Finding sufficient time for a trial is a challenging task for involved physicians, especially when it is conducted in parallel to patient care. From the point of view of medical informatics, the growing amount of electronically available patient data allows to support two key activities: the recruitment of patients into the study and the documentation of trial data. Methods: The project was carried out at one site of a European multicenter study. The study protocol required eligibility assessment for 510 patients in one week and the documentation of 46-186 data elements per patient. A database query based on routine data from patient care was set up to identify eligible patients and its results were compared to those of manual recruitment. Additionally, routine data was used to pre-populate the paper-based case report forms and the time necessary to fill in the remaining data elements was compared to completely manual data collection. Results: Even though manual recruitment of 327 patients already achieved high sensitivity (88%) and specificity (87%), the subsequent electronic report helped to include 42 (14%) additional patients and identified 21 (7%) patients, who were incorrectly included. Pre-populating the case report forms decreased the time required for documentation from a median of 255 to 30s. Conclusions: Reuse of routine data can help to improve the quality of patient recruitment and may reduce the time needed for data acquisition. These benefits can exceed the efforts required for development and implementation of the corresponding electronic support systems. (C) 2012 Elsevier Ireland Ltd. All rights reserved.