有效的临床项目管理,简化临床试验

M. Patel
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引用次数: 2

摘要

临床研究行业使用项目管理工具支持药物开发过程需要大量的时间和精力。问题是,临床试验是项目吗?临床试验已经定义了开始和结束,不管它是否会持续几个月到10-15年。进行临床试验的财力和人力资源都是有限的。将临床试验作为一个项目来处理是非常健康的,这样可以使管理得到良好的定义和结构。每个临床试验的交付成果都是独一无二的,但它可以被定义为结果。临床试验的特点是逐步细化,精心准备的临床试验方案(CTP)就是一个逐步发展的例子。管理临床试验需要有效的试验管理,无论其规模和复杂性如何。在过去的三十年里,工业界发明并重新发明了审判管理轮。为了提高成功和及时的交付,是时候制定标准的试验管理指南了。
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Effective Clinical Project Management to Streamline Clinical Trial
There is serious amount of time and efforts involved in clinical research industry supporting the drug development process with the project management tool. The question arise is, is clinical trial project? Clinical trial has defined beginning and end, no matter whether it will continue for several months to 10-15 years. The finance and human resources for conducting those trials are finite It is quite healthy to handle clinical trial as a project which makes management well defined and structured. The deliverable of every clinical trials is unique, but it can be defined as result. clinical trial is always characterized by its progressive elaboration and a well-prepared clinical trial protocol (CTP) is an example of a step of development. Managing clinical trial required efficient trial management, whatever the size and complexity it is. For the past three decades, industry has invented and reinvented the trial management wheel. To improve the successful and timely delivery, it is time to produce standard trial management guidelines.
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