This paper deals with the basic principles involved in sample size calculation of phase III cancer clinical trials. It illustrates the concepts and factors determining the sample size. Various examples of phase III cancer clinical trials are provided and the sample size is calculated taking into account the assumptions made. The examples provided include sample sizes for comparing proportions and sample sizes for comparing survival times. Several special topics are also discussed including choice of endpoint, number of treatment groups, factorial designs and equivalence trials.
Copyright 1999 W.B. Saunders Company Ltd.