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A New Software Development Methodology for Clinical Trial Systems

机译：临床试验系统的新软件开发方法

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Clinical trials are crucial to modern healthcare industries, and information technologies have been employed to improve the quality of data collected in trials and reduce the overall cost of data processing. While developing software for clinical trials, one needs to take into account the similar patterns shared by all clinical trial software. Such patterns exist because of the unique properties of clinical trials and the rigorous regulations imposed by the government for the reasons of subject safety. Among the existing software development methodologies, none, unfortunately, was built specifically upon these properties and patterns and therefore works sufficiently well. In this paper, the process of clinical trials is reviewed, and the unique properties of clinical trial system development are explained thoroughly. Based on the properties, a new software development methodology is then proposed specifically for developing electronic clinical trial systems. A case study shows that, by adopting the proposed methodology, high-quality software products can be delivered on schedule within budget. With such high-quality software, data collection, management, and analysis can be more efficient, accurate, and inexpensive, which in turn will improve the overall quality of clinical trials.
机译：临床试验对现代医疗保健行业至关重要，并且已采用信息技术来提高试验中收集的数据质量并降低数据处理的总体成本。在开发用于临床试验的软件时，需要考虑所有临床试验软件共享的相似模式。之所以存在这种模式，是因为临床试验具有独特的性质，并且政府出于受试者安全的原因而制定了严格的规定。不幸的是，在现有的软件开发方法中，没有一种是专门基于这些属性和模式构建的，因此效果很好。本文对临床试验的过程进行了回顾，并对临床试验系统开发的独特性质进行了详尽的解释。基于这些特性，然后提出了一种新的软件开发方法，专门用于开发电子临床试验系统。案例研究表明，通过采用建议的方法，可以在预算内按计划交付高质量的软件产品。使用这种高质量的软件，数据收集，管理和分析可以更加高效，准确和廉价，从而提高临床试验的整体质量。

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