Abstract
Internet-based clinical trials (IBCTs) are rapidly changing the current paradigms of clinical research, data management, statistical analyses, medical writing, and even regulatory submissions and reviews. Competitive forces are driving the implementation of IBCTs in that they provide cost-effective solutions for streamlining areas such as patient enrollment, data entry, query management, communications, regulatory review, and project management. By reducing data entry errors through the use of online edit and logic checks, there is improved data quality as well as a reduction in the time to database lock.
Company-sponsored clinical research has always had project management as an important component. By providing online reports directly from the database, IBCTs significantly improve the project management aspects of clinical research and reduce or even eliminate many project management expenses. Within 2 years, by necessity, sponsored clinical research will use some form of Internet-based system to assist in the conduct of clinical trials. This will occur as: (i) the prices for Internet-based systems fall with more competition; (ii) there is increasing confidence in the use of electronic data; and (iii) economies of scale develop as studies with similar designs, architectures, and business rules are implemented.
Benefits, structural changes, examples of cost savings, practical recommendations for program implementation, and selected metrics (measurements of system performance) are presented. While the benefits for IBCTs are in the areas of randomized controlled trials, postmarketing studies, patient registry studies, and project and safety management, this article focuses on randomized controlled trials. This article is based on IBCT experience in the US, Europe, and the Middle East.
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Mitchel, J.T., You, J., Kim, Y.J. et al. Internet-Based Clinical Trials. Pharm Dev Regul 1, 29–39 (2003). https://doi.org/10.1007/BF03257363
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DOI: https://doi.org/10.1007/BF03257363