Methodology
Phase III
Pivotal phase: efficacy vs. standard of care.
Phase III trials are large (1000-3000 subjects), randomized, controlled, usually multicenter. Compare the new treatment with current standard. Basis for FDA/EMA regulatory approval.
Methodology
Pivotal phase: efficacy vs. standard of care.
Phase III trials are large (1000-3000 subjects), randomized, controlled, usually multicenter. Compare the new treatment with current standard. Basis for FDA/EMA regulatory approval.