Abstract:
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In comparative clinical endpoint studies with a binary outcome, a generic product (TEST) and the Reference Listed Drug (RLD) are considered to be equivalent if the 90% confidence interval for the difference in success or cure rates between the two products is within [-20%, 20%]. This method, however, is not equally sensitive for delimiting a difference between TEST and RLD across the response range. This is particularly problematic when the success rate for RLD is expected to be low. Therefore we propose a two-step method instead. Through simulation, we show that our proposed method can control the passing probability for products with relatively low success rate, and meanwhile maintain high power with reasonable sample size when Test and RLD are actually equivalent.
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