Utility-based optimization of Fujikawa's basket trial design – Pre-specified protocol of a comparison study
arxiv(2024)
Abstract
Basket trial designs are a type of master protocol in which the same therapy
is tested in several strata of the patient cohort. Many basket trial designs
implement borrowing mechanisms. These allow sharing information between similar
strata with the goal of increasing power in responsive strata while at the same
time constraining type-I error inflation to a bearable threshold. These
borrowing mechanisms can be tuned using numerical tuning parameters. The
optimal choice of these tuning parameters is subject to research. In a
comparison study using simulations and numerical calculations, we are planning
to investigate the use of utility functions for quantifying the compromise
between power and type-I error inflation and the use of numerical optimization
algorithms for optimizing these functions. The present document is the protocol
of this comparison study, defining each step of the study in accordance with
the ADEMP scheme for pre-specification of simulation studies.
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