McKenna, L., Frick, M., Alarcón-Guizado, V. A., Davies, G., Furin, J. J., Guglielmetti, L., Heinrich, N., Low, M., Mahmoud, M., Mave, V., Ndjeka, N., Phillips, P. P. J., Schumacher, S., Harrington, M., & Mitnick, C. D. (2026). When are uncontrolled trials in TB scientifically and ethically justified: Borrowing wisdom from early AIDS clinical trials. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, ciag175. Advance online publication. https://doi.org/10.1093/cid/ciag175
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.
