Abstract:
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Group sequential trial methodology employed in clinical trials is analytically a multivariate normal distribution situation. But, theoretical results have shown that all the necessary computations to implement the methodology, can be carried out using only bivariate normal distribution. For students, leave alone multivariate normal distribution, even dealing with bivariate normal distribution is a daunting task. There are standard software packages available for implementing group sequential methodology. But even for professionals using such software, the computations carried out in them are from a black box. This is more so for students and for non-statistician professionals engaged in clinical trials like programmers. One alternative way is to introduce them to group sequential methodology with simple terminology and hands on procedures using a free bivariate normal distribution calculator that can be downloaded from an internet website. The procedures given in the paper provide a rigorous introduction to group sequential methodology with hands on experience on computations and have been tested successfully in training computer programmers working in clinical trials area.
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