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

Area of Science:

• Clinical Trial Design
• Biostatistics
• Pharmaceutical Research

Background:

• Multi-Arm, Multi-Stage (MAMS) designs facilitate comparing multiple therapies across trial phases.
• Factorial designs combined with MAMS enhance efficiency over traditional fixed designs.
• Factorial Adaptive Multi-Arm Multi-Stage (FAST) designs integrate factorial and MAMS approaches.

Purpose of the Study:

• To explore design choices for FAST trials.
• To assess the impact of analysis type, timing, and effect size on FAST trial operating characteristics.
• To evaluate the potential benefits of FAST designs compared to MAMS and factorial designs.

Main Methods:

• Simulation studies were employed to analyze FAST designs.
• The impact of analysis type, timing, and effect size on trial operating characteristics was assessed.
• Analysis approaches varied based on data type for multiple outcomes.

Main Results:

• FAST designs offer a framework for potential improvements over MAMS and factorial trials.
• Design implementation decisions significantly influence trial operating characteristics.
• Simulation results highlight the importance of analysis timing and type.

Conclusions:

• FAST trials can potentially offer advantages similar to both MAMS and factorial designs.
• Thorough exploration of design aspects during the planning phase is essential for FAST trials.
• The chosen design elements critically impact the success and efficiency of FAST trials.