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When are Uncontrolled Trials in TB Scientifically and Ethically Justified: Borrowing Wisdom From Early AIDS Clinical Trials

Year: 2026

Type: article

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.

Source: Clinical Infectious Diseases

DOI: 10.1093/cid/ciag175

Authors: Lindsay McKenna, Mike Frick, Valentina A Alarcón-Guizado, Geraint R Davies, Jennifer J Furin, Lorenzo Guglielmetti, Norbert Heinrich, Marcus Low, Mariama Mahmoud, Vidya Mave, Norbert Ndjeka, Patrick P J Phillips, Samuel Schumacher, Mark Harrington, Carole D Mitnick

Institutions: Treatment Action Group, Ministry of Health, University of Liverpool, Harvard University, Ospedale Sacro Cuore Don Calabria, LMU Klinikum, Fraunhofer Institute for Translational Medicine and Pharmacology, German Center for Infection Research, Institut für Infektions- und Tropenmedizin, Ludwig-Maximilians-Universität München, Johns Hopkins University, Department of Health, University of California, San Francisco, World Health Organization

Language: English

Topic: Statistical Methods in Clinical Trials

Subfield: Statistics and Probability

Field: Mathematics

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: hybrid

Estimated APC paid: $4,763

Funders: U.S. Department of State, Ministero della Salute, Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale", National Institutes of Health, Centers for Disease Control and Prevention

Award: G1782398782

OpenAlex ID: W7135238068

FWCI:

Cites: 15

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