Safety Issues

Stopping a clinical trial because of an emergent safety problem, either by a medical monitor or by a safety committee, is always a unique situation. Little useful, generalizable guidance can be provided here. These are decisions that are always taken in consultation, and the safety of potential future trial recruits must be the paramount concern (including the abrupt cessation of therapy). Trial suspension is usually the best immediate option, allowing time for collective thought, notification of regulatory authorities and wider consultations as appropriate.

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