Clinical trials are crucial to modern healthcare industries, and information technologies have been employed to improve the quality\r\nof data collected in trials and reduce the overall cost of data processing.While developing software for clinical trials, one needs to\r\ntake into account the similar patterns shared by all clinical trial software. Such patterns exist because of the unique properties of\r\nclinical trials and the rigorous regulations imposed by the government for the reasons of subject safety. Among the existing software\r\ndevelopment methodologies, none, unfortunately, was built specifically upon these properties and patterns and therefore works\r\nsufficientlywell. In this paper, the process of clinical trials is reviewed, and the unique properties of clinical trial system development\r\nare explained thoroughly. Based on the properties, a new software development methodology is then proposed specifically for\r\ndeveloping electronic clinical trial systems. A case study shows that, by adopting the proposed methodology, high-quality software\r\nproducts can be delivered on schedule within budget.With such high-quality software, data collection, management, and analysis\r\ncan be more efficient, accurate, and inexpensive, which in turn will improve the overall quality of clinical trials.
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