Generalized Design of Basket Trials with P-value Combination Test

TL;DR

This paper introduces a flexible, generalized framework for basket trial design using P-value combination tests, extending the P&P approach beyond binary endpoints for broader application.

Contribution

It proposes a novel, P-value based framework for basket trials that enhances flexibility and applicability of the pruning and pooling approach.

Findings

Framework allows use of any P-values for decision making

Enhances flexibility of basket trial designs

Broadens application beyond binary endpoints

Abstract

The oncology exploratory basket trial design with pruning and pooling (P&P) approach has gained increasing popularity in recent years for its simplicity and efficiency. This method was proposed based on binary endpoint, limiting its wider application. This short communication proposed a generalized framework of using P-value combination test to implement pruning and pooling process in basket trials. Only P-values of any type of statistical testing from each cohort are needed for decision making, which provides great flexibility for basket trial designs with P&P approach.