Response adaptive designs for Phase II trials with binary endpoint based on context-dependent information measures.

ABSTRACT: In many rare disease Phase II clinical trials, two objectives are of interest to an investigator: maximising the statistical power and maximising the number of patients responding to the treatment. These two objectives are competing, therefore, clinical trial designs offering a balance between them are needed. Recently, it was argued that response-adaptive designs such as families of multi-arm bandit (MAB) methods could provide the means for achieving this balance. Furthermore, response-adaptive designs based on a concept of context-dependent (weighted) information criteria were recently proposed with a focus on Shannon's differential entropy. The information-theoretic designs based on the weighted Renyi, Tsallis and Fisher informations are also proposed. Due to built-in parameters of thes

SUBMITTER: Kasianova K 

PROVIDER: S-EPMC7985674 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature