Paradigm shifts in clinical trials enabled by information technology.

The use of the world wide web for clinical trials changes the processes of performing clinical research in several fundamental ways. Greatly improved security, monitoring capability, and accuracy and timeliness of study conduct can be achieved while lowering cost. Data quality is enhanced while co-ordinating centre effort is reduced. The web provides a natural environment for linking the various components of clinical research, leading to new levels of simplicity and efficiency. It also enhances opportunities for recruitment of study investigators and patients. Other information technology tools and databases can be used to assist in this regard as well. Web-based trials change the relationship of the investigator site to the study and the site to the co-ordinating centre. Different roles and responsibilities lead to simplified processes and more and higher quality data. Many standard co-ordinating centre activities, such as randomization, protocol implementation and amending, document tracking, adverse event reporting, site monitoring, report generation and data analysis are all fundamentally changed in a web-based trial. Opportunities are enhanced to identify potential investigators and support their successful study conduct. As the role of investigator sites is changed in web-based research, more primary care medical providers can be attracted to research, providing more typical patients to studies than those sometimes available through more traditional research sites, especially those at academic study sites. Other activities can now be co-ordinated electronically with the advent of the web. The Institutional Review Board (IRB) can use online tools to control investigator participation, resulting in improved study efficiency and patient safety. A web-based research pharmacy provides tremendous efficiencies in managing and distributing study medications. Financial payments to the sites can be performed and recorded electronically, or even administered based on timeliness and quality of the data. Our early experience with web-based trials indicates that there can be tremendous gains in study efficiency and accuracy by restructuring processes, roles and responsibilities through a comprehensive centralized, web-based trial. The future appears bright for web-based clinical trials. Copyright 2001 John Wiley & Sons, Ltd.