1 MRC Clinical Trials Unit at UCL, University College London, London, UK.
2 Faculty of Health, Education and Life Sciences, Birmingham City University, Birmingham, UK.
Clin Trials. 2017 Oct;14(5):451-461. doi: 10.1177/1740774517725697. Epub 2017 Aug 22.
There is real need to change how we do some of our clinical trials, as currently the testing and development process is too slow, too costly and too failure-prone often we find that a new treatment is no better than the current standard. Much of the focus on the development and testing pathway has been in improving the design of phase I and II trials. In this article, we present examples of new methods for improving the design of phase III trials (and the necessary lead up to them) as they are the most time-consuming and expensive part of the pathway. Key to all these methods is the aim to test many treatments and/or pose many therapeutic questions within one protocol.
我们确实需要改变进行某些临床试验的方式,因为目前的测试和开发过程过于缓慢、成本过高且容易失败——我们经常发现新的治疗方法并不比现有标准更好。在开发和测试途径上的大部分重点都集中在改进 I 期和 II 期试验的设计上。在本文中,我们提出了改进 III 期试验设计(以及必要的前期准备)的新方法示例,因为它们是该途径中最耗时和最昂贵的部分。所有这些方法的关键都是旨在在一个方案中测试多种治疗方法和/或提出许多治疗问题。