The 6-Month RR-TB Trial the FDA Should Be Studying as a Pragmatic Design Blueprint
β’ A recent New England Journal of Medicine (NEJM) pragmatic trial tested a 6-month rifampicin-resistant tuberculosis (RR-TB) regimen, establishing a new benchmark for adaptive evidence generation. β’ The trial embedded randomization directly into existing treatment infrastructure to bypass the lengthy 18-month site qualification and rigid eligibility criteria typical of conventional Phase 3 development. β’ This approach addresses a critical public health crisis, as the WHO Global Tuberculosis Report 2025 estimates 390,000 new MDR/RR-TB cases annually and 150,000 drug-resistant TB deaths in 2024.
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