Which statement best describes stopping rules in a trial's data safety monitoring plan?

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Stopping rules are the predefined criteria that determine whether a trial should stop before its planned end based on interim data. In a data safety monitoring plan, an independent committee reviews safety (and sometimes efficacy) data at set points. If the interim analyses show unacceptable risk to participants, the stopping rules authorize stopping the trial early to protect them. This protective action reflects the ethical obligation to minimize harm while avoiding unnecessary exposure to a study with ongoing safety concerns. Increasing sample size does not automatically ensure safety, and stopping rules are not optional or limited to marketing plans—they are a fundamental part of trial safety and are actively reviewed.