Parmar M K, Spiegelhalter D J, Freedman L S
MRC Cancer Trials Office, Cambridge, U.K.
Stat Med. 1994;13(13-14):1297-312. doi: 10.1002/sim.4780131304.
In this paper we describe the design and monitoring of two large randomized trials being conducted through the British Medical Research Council (MRC) Cancer Trials Office. In particular we discuss the issues involved in the design of the trials, specifying the null and alternative hypotheses and how the design has influenced the monitoring procedure used. From these two examples, and some other MRC experiences, we suggest some basic considerations which could be applied to many MRC and other trials.
在本文中,我们描述了通过英国医学研究理事会(MRC)癌症试验办公室开展的两项大型随机试验的设计与监测情况。我们特别讨论了试验设计中涉及的问题,明确了原假设和备择假设,以及设计如何影响所采用的监测程序。从这两个例子以及MRC的其他一些经验中,我们提出了一些基本的考量因素,这些因素可应用于许多MRC及其他试验。