Stopping Rules

Stopping rules define a safety criteria primarily used in early phase clinical trials to determine when the study needs to be paused or halted.

These rules are constructed to be in the form of a standardized algorithm based approach that fulfills the regulatory requirements while taking into account the design and anticipated risks of the trial.

Source: Coates, S., Täubel, J., & Lorch, U. (2018). Practical risk management in early phase clinical trials. European Journal of Clinical Pharmacology, 75(4), 483–496.