Adapt to survive and thrive: the time is now for adaptive platform trials for preterm birth

Area of Science:

• Perinatal clinical research
• Clinical trial methodology
• Bayesian statistics

Background:

• Traditional two-arm randomized trials with frequentist analysis present limitations for perinatal research.
• Unique challenges in perinatology necessitate innovative research approaches.
• Current methods may not be optimal for addressing complex perinatal health questions.

Purpose of the Study:

• To discuss the challenges in perinatal clinical research.
• To propose adaptive platform trials (APTs) with Bayesian methodology as a solution.
• To improve outcomes for preterm birth through enhanced research designs.

Main Methods:

• Utilizing a master protocol for efficient simultaneous assessment of multiple interventions.
• Implementing adaptive designs allowing interventions to enter or leave the platform.
• Employing Bayesian methodology for data analysis within APTs.

Main Results:

• APTs can overcome specific issues inherent in perinatal clinical research.
• This approach allows for continuous evaluation and adaptation of interventions.
• Potential for more efficient and responsive clinical research in perinatology.

Conclusions:

• Adaptive platform trials with Bayesian methods are well-suited for perinatology.
• Successful implementation requires careful consideration of design and requirements.
• APTs offer a promising pathway to advance preterm birth research and improve infant outcomes.