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Phase 3 Pivotal Trials

Meaning

Phase 3 Pivotal Trials represent the definitive, large-scale stage of clinical research conducted just before a new drug or intervention is submitted for regulatory approval. These trials are designed to confirm the efficacy and monitor the safety of the treatment in a large, diverse patient population, often involving hundreds to thousands of participants across multiple global centers. The term “pivotal” signifies that the results of this phase are the primary, critical evidence used by regulatory agencies like the FDA to determine whether a new product’s benefits outweigh its risks for widespread public use.