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The homogeneity assumption of a Simon Phase II clinical trial is commonly violated due to excess variation in the response known as response heterogeneity. Using a general framework to model heterogeneity, we investigate its effects on the operating characteristics of the Simon trial design using the standard practice of averaging responses. We show that, under heterogeneity and averaging, the Simon designs have higher than expected errors which may result in false negative and false positive Phase II outcomes. Keywords: Simon Trial, Phase II, heterogeneity Introduction Simon Phase II designs are single arm trial designs used to estimate efficacy for an experimental treatment. The primary assumption for this type of trial is the assumption of response homogeneity. Response homogeneity is defined as the variance of the response being bounded by the variance of a binomial distribution given a response rate, π. 1 In practice, this assumption may be violated with the response variation greater than expected. An explanation for the increase in response variation or response heterogeneity is the existence of unique subgroups in the population.

The effects of heterogeneity on Simon Phase II clinical trial design operating characteristics