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Explore how DSMBs review safety signals, assess benefit risk, manage interim analyses, and document trial decisions. This guide explains the evidence, controls, and inspection-ready records pharmaceutical teams need to strengthen clinical trial oversight and support regulatory compliance
Novartis paused eight clinical trials of an experimental CAR-T therapy for autoimmune and neurological disorders in late August after 3 patient deaths linked to a severe immune response. The Swiss drugmaker is reviewing the safety events with independent safety boards