# Utility-based optimization of Fujikawa’s basket trial design – Pre-specified protocol of a comparison study

## TL;DR

This paper outlines a study protocol to compare how utility functions and optimization algorithms can improve basket trial designs in clinical research.

## Contribution

The study introduces a novel approach to optimize basket trial designs using utility functions and numerical optimization algorithms.

## Key findings

- The study will use simulations to evaluate utility-based optimization in basket trials.
- The protocol follows the ADEMP framework for pre-specifying simulation study steps.
- The goal is to balance statistical power and type-I error inflation in borrowing mechanisms.

## 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.