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Updated: Mar 14, 2026

System for Efficacy and Cytotoxicity Screening of Inhibitors Targeting Intracellular Mycobacterium tuberculosis
Published on: April 5, 2017
When are Uncontrolled Trials in TB Scientifically and Ethically Justified: Borrowing Wisdom From Early AIDS Clinical
Lindsay McKenna1, Mike Frick1, Valentina A Alarcón-Guizado2
1Tuberculosis Project, Treatment Action Group, New York, New York, USA.
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.
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