Design considerations for Factorial Adaptive Multi-Arm Multi-Stage (FAST) clinical trials.

ABSTRACT:

Background

Multi-Arm, Multi-Stage (MAMS) clinical trial designs allow for multiple therapies to be compared across a spectrum of clinical trial phases. MAMS designs fall under several overarching design groups, including adaptive designs (AD) and multi-arm (MA) designs. Factorial clinical trials designs represent a combination of factorial and MAMS trial designs and can provide increased efficiency relative to fixed, traditional designs. We explore design choices associated with Factorial Adaptive Multi-Arm Multi-Stage (FAST) designs, which represent the combination of factorial and MAMS designs.

Methods

Simulation studies were conducted to assess the impact of the type of analyses, the timing of analyses, and the effect size observed across multiple outcomes on trial operat

SUBMITTER: Beall J 

PROVIDER: S-EPMC11391813 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature