Methodological review to develop a list of bias items for adaptive clinical trials: Protocol and rationale

ABSTRACT Background Randomized-clinical trials (RCTs) are the gold-standard for comparing health care interventions, but can be limited by early termination, feasibility issues, and prolonged time to trial reporting. In contrast, adaptive clinical trials (ACTs), which are defined by pre-planned modifications and analyses that occur after starting patient recruitment, are gaining popularity as they can streamline trial design and time to …