A New Software Development Methodology for Clinical Trial Systems

Li-Min Liu
<span title="">2013</span> <i title="Hindawi Limited"> <a target="_blank" rel="noopener" href="https://fatcat.wiki/container/qealiiqfznhzppsutrnxz7eogq" style="color: black;">Advances in Software Engineering</a> </i> &nbsp;
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
more &raquo; ... 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.
<span class="external-identifiers"> <a target="_blank" rel="external noopener noreferrer" href="https://doi.org/10.1155/2013/796505">doi:10.1155/2013/796505</a> <a target="_blank" rel="external noopener" href="https://fatcat.wiki/release/hyjmg5lmerfcndlondgkbyrdla">fatcat:hyjmg5lmerfcndlondgkbyrdla</a> </span>
<a target="_blank" rel="noopener" href="https://web.archive.org/web/20200211215815/http://downloads.hindawi.com/archive/2013/796505.pdf" title="fulltext PDF download" data-goatcounter-click="serp-fulltext" data-goatcounter-title="serp-fulltext"> <button class="ui simple right pointing dropdown compact black labeled icon button serp-button"> <i class="icon ia-icon"></i> Web Archive [PDF] <div class="menu fulltext-thumbnail"> <img src="https://blobs.fatcat.wiki/thumbnail/pdf/8a/e3/8ae310fb7db5f1b8e6744942527f648f061f737b.180px.jpg" alt="fulltext thumbnail" loading="lazy"> </div> </button> </a> <a target="_blank" rel="external noopener noreferrer" href="https://doi.org/10.1155/2013/796505"> <button class="ui left aligned compact blue labeled icon button serp-button"> <i class="unlock alternate icon" style="background-color: #fb971f;"></i> hindawi.com </button> </a>