Strategies for changing the test statistic during a clinical trial.
This article discusses the design of a clinical trial where a new treatment will be compared to a control. For a specific type of endpoint, there are a wide variety of test statistics that can be used. Also, the investigator must decide how many patients to accrue in each arm as well as the duration of the study. After an interim look at the data, the investigator may decide that a different test statistic would be more powerful or that more patients or longer follow-up is needed. In this article, we discuss a strategy for making these types of changes. This strategy controls the probability of making a type I error and can result in a procedure that has higher power than the test without adaptation.
Lawrence
John
J
Division of Biometrics I, Food and Drug Administration, Rockville, MD 20852, USA.
D002986:Clinical Trials as Topic / Q000379:methods / Q000706:statistics & numerical data*; D004311:Double-Blind Method; D006801:Humans; D015233:Models, Statistical; D011237:Predictive Value of Tests; D011897:Random Allocation; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000706:statistics & numerical data