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Phase 3 Trials

Meaning

Phase 3 Trials represent the third and penultimate stage of clinical research, designed to definitively confirm the efficacy, monitor the safety, and assess the overall benefit-risk profile of a new drug or therapeutic intervention. These large-scale, multi-center, randomized controlled trials involve hundreds to thousands of participants and compare the new treatment against a placebo or the current standard of care. For novel hormonal therapies, Phase 3 results provide the critical, generalizable knowledge required by regulatory bodies like the FDA for market approval and subsequent clinical integration.