The science of web-based clinical trial management

Good science requires good data. Careful observation and precise measurement are fundamental to scientific progress and nowhere more so than for multicenter clinical trials, where the details of data management are sometimes considered during scientific reviews. Operation of successful and efficient multicenter studies makes increasingly intensive use of web-based functions and directed database design attractive for almost every aspect of coordination and communication. This technology has advanced considerably over the last five or ten years and continues to evolve rapidly. Recent changes in the regulatory environment due to HIPAA created a sudden and ongoing need for adaptation in transmission of electronic data. All things considered, web-based data management is one of the most critical, dynamic and dare we say exciting areas of study coordination. The design of computer systems for study coordination is increasingly an intellectual challenge. There is a variety of software available for the design of customized database management, web applications and webpage design; in addition, many "off-the-shelf" systems promise suites of functions that can be adapted to specific studies with minimal effort. Web-based systems include data entry, of course, but often extend to code generation tools for forms and data validation, document management, shipment and specimen tracking, transmission of nonform data (e.g., laboratory measurements), report management and reports on live data, query resolution, adjudication of study outcomes, scheduling for participant visits, and other study management tasks. It may be tempting to simplify things by using an off-the-shelf system instead of developing a customized one, but it is important to recognize that both have limitations and it can be difficult to assess the trade offs. Off-the-shelf applications may be implemented more quickly, but they may not take full advantage of available technology or current thinking on system design. Customization takes longer to implement and requires more highly trained personnel, but can be designed with participating clinics' internal organization and other unique study aspects in mind. This may lead to savings in the long run for studies of substantial scope. In some environments a coordinating center is faced with many similar trials, or, like a contract research organization, is able to require a high level