Randomised clinical trials in critical care: past, present and future

Area of Science:

• Critical care medicine
• Clinical trial methodology

Background:

• Randomised clinical trials (RCTs) are the benchmark for unbiased evidence.
• Critical care RCTs face limitations: optimistic effect sizes, dichotomized outcomes, narrow focus, inflexibility, and inefficiency.

Purpose of the Study:

• To review the history and challenges of critical care RCTs.
• To explore novel methods and adaptive designs for improving RCTs in critical care.

Main Methods:

• Overview of RCT history and critical care RCT limitations.
• Discussion of recent developments: research programs, standardized protocols, alternative outcomes, Bayesian statistics, platform trials, and clinical integration.

Main Results:

• Identified key challenges in current critical care RCTs.
• Presented novel approaches like adaptive and platform trials, and Bayesian statistics as potential solutions.
• Outlined advantages and disadvantages of these innovative methods.

Conclusions:

• Critical care RCTs can be improved through novel designs and methods.
• Adaptive and platform trials, alongside Bayesian analysis, offer enhanced flexibility and efficiency.
• Informed clinicians and researchers on choosing appropriate RCT methodologies for critical care research.