When are uncontrolled trials in TB scientifically and ethically justified: Borrowing wisdom from early AIDS clinical trials.

McKenna, Lindsay; Frick, Mike; Alarcón-Guizado, Valentina A; Davies, Geraint; Furin, Jennifer J; Guglielmetti, Lorenzo; Heinrich, Norbert; Low, Marcus et al. · Clin Infect Dis · 2026

review · Level V

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Abstract

Tuberculosis treatment trials have used various comparison strategies. To inform trial design for novel tuberculosis regimens, we applied an existing framework for evaluating when uncontrolled trials might be justified. We conclude that the conditions are not met for tuberculosis treatment and that uncontrolled phase 3 trials should not be performed.