Lecture "Context-dependent Measures in Clinical Trials"

In November 27 Ksenia Kasianova (HSE) delivered a lecture «Context-dependent measures in clinical trials»

Abstract: In many rare disease Phase II clinical trials, two objectives are of interest to an investigator: maximizing the statistical power and maximizing 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 a response-adaptive designs based on a concept of context-dependent (weighted) information criteria were proposed as a method which can provide the means for achieving this balance. Due to built-in parameters of these novel designs, the balance between the statistical power and the number of patients that respond to the treatment can be tuned explicitly. The asymptotic properties of these measures are studied in order to construct intuitive criteria for arm selection. The proposed designs based on information-theoretical criteria are compared to several alternative approaches. For example, it is shown that via tuning of the built-in parameter, one can find designs resulting in сomparable to the fixed equal randomization’s power but a greater number of patients responded in the trials.
Ksenia Kasianova_presentation.pdf