A free gift: an adaptive strategy in a single-arm trial using an exact test through the binomial distribution.
For medical product development within the same generation, single-arm trial designs are commonly implemented to test the performance of the new product against an objective performance criterion. When the primary endpoint is binary and the sample size is moderate, an exact test through the binomial distribution is usually used. This article shows that it is a free gift to add an adaptive component to a fixed-sample-size design so that when the interim result is marginal, the adaptive feature can be activated without any penalty. A hypothetical example is used to illustrate the application of this method.
Abbott Vascular-Biostatistics, Santa Clara, California 95054, USA. jin.wang@av.abbott.com
Jin
J
Wang
D016010:Binomial Distribution; D002986:Clinical Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data*; D003627:Data Interpretation, Statistical; D054855:Drug-Eluting Stents; D023381:Endpoint Determination; D006801:Humans; D015233:Models, Statistical; D012107:Research Design / Q000706:statistics & numerical data*; D018401:Sample Size