eSource-Enabled vs. Traditional Clinical Trial Data Collection Methods: A Site-Level Economic Analysis

摘要

Directly extracting data from site electronic health records for updating clinical trial databases (eSource) can reduce site data collection times and errors. We conducted a study to determine clinical trial characteristics that make eSource vs. traditional data collection methods more and less economically attractive. The number of patients a site enrolls, the number of study data elements, study coordinator data collection times, and the percent of study data elements that can be extracted via eSource software all impact eSource economic attractiveness. However, these factors may not impact all clinical trial designs in the same way.