Clinical Operations Online (Cool)—A World Wide Web-Based Approach to Running Clinical Trials: Results from Two International Multicenter Gastrointestinal Trials

Abstract

Internet solution for online communication of clinical research data between the investigator, the clinical study monitor, a central laboratory for blood and urine analysis, and Astra Hassle AB was evaluated in two international multicenter studies involving 894 patients from 78 centers in 9 countries across Europe and Canada. For access to the common information space, a security system combining a unique user name and one-time passwords was used. The Internet application allowed investigators to create patient records and enter data for existing patients into the electronic case report form (eCRF). Certain data were checked immediately at data entry, resulting in automaticallygenerated questions. Additional data checks were also performed on data each night, the results of which were made available for the monitors using the Web application. Thanks to the immediate availability of clinical study data and the data checks, the study monitors were able to monitor the eCRFs and generate questions on unclear or inconsistent data, both immediately after they had been entered at the study site, and within 24 hours after data entry using the data checks.Measures of lead times clearly showed positive effects. The time from last data available to clean file was, on average, six days. The additional workload was considered reasonable, despite the use of a paper workbook as a back-up in these studies. This is the first time this concept and technology has been reported, and it suggests a shiji in paradigm. From a scientific, time, resource, and logistic point of view, an approach based on use of the World Wide Web offers advantages to paper-based systems.

Electronic Data Capture-Selecting an EDC System

“…30 Leveraging technology to do new things or to do things in new ways changes, i.e., gaining benefit from the technology requires re-engineering organizational processes. 10,[12][13][14][15][16][17][18][19] [III] As such, organizational processes should be expected to change as the organization implements new technology. Organizational process changes when implementing EDC can be significant because EDC touches organizational processes involving the collection, processing, and use of data during a study.…”

“…It has been argued that the real gains from EDC come with use of the technology to re-engineer processes. 10,[12][13][14][15][16][17][18][19] Organizations must decide to what extent a new system needs to support existing processes for data collection, management, and monitoring versus offer new ways of working. EDC system selection and implementation usually involves many stakeholders including, but not limited to, project management, data management, clinical management, biostatistics, and information technology.…”