Regulatory Acceptance of Adaptive Changes
Regulatory Acceptance of Adaptive Changes Understanding Regulatory Acceptance of Adaptive Modifications in Clinical Trials Introduction: Balancing Flexibility and Integrity Adaptive designs allow clinical trials to evolve based on accumulating interim data. Mid-trial modifications—such as sample size re-estimation, dropping or adding arms, or adjusting randomization ratios—can improve efficiency and patient safety. However, regulators require strict safeguards…