Key considerations for planning adaptive platform trials: part 2

Area of Science:

• Clinical Trials Methodology
• Biostatistics
• Health Services Research

Background:

• Adaptive platform trials (APTs) are complex, flexible, and efficient randomized clinical trials (RCTs).
• APTs allow continuous addition of interventions within a core protocol, enabling perpetual operation.
• Despite benefits, planning APTs presents challenges due to limited available guidance.

Purpose of the Study:

• To provide a narrative overview of key considerations for planning adaptive platform trials.
• To offer guidance based on practical experience in planning and initiating APTs.
• To support researchers in the complex process of designing and implementing APTs.

Main Methods:

• This is the second part of a two-part series on APT planning.
• The series provides a narrative overview of essential planning considerations.
• Focuses on statistical, operational, and logistical aspects of APTs.

Main Results:

• The first part covered stakeholder involvement, population, interventions, outcomes, and adaptations.
• This part details considerations for statistics, design features, data infrastructure, operations, funding, dissemination, and implementation.
• A comprehensive list of 7 key considerations for APT planning is presented.

Conclusions:

• The guidance provided aims to assist researchers in planning adaptive platform trials.
• Effective planning is crucial for the successful implementation of APTs.
• This series contributes to the limited body of knowledge on APT design and execution.