When are uncontrolled trials in TB scientifically and ethically justified: Borrowing wisdom from early AIDS clinical trials
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.
Authors
- Marcus Low (ORCID: https://orcid.org/0000-0002-4325-2297)
- Mike Frick (ORCID: https://orcid.org/0000-0002-3316-1930)
- Jennifer Furin (ORCID: https://orcid.org/0000-0002-0825-7199)
- Norbert Ndjeka (ORCID: https://orcid.org/0000-0001-6200-1592)
- Samuel G. Schumacher (ORCID: https://orcid.org/0000-0002-6136-206X)
- Lindsay McKenna (ORCID: https://orcid.org/0000-0002-4703-0835)
- Carole D. Mitnick (ORCID: https://orcid.org/0000-0002-3455-658X)
- Mariama Mahmoud
- Norbert Heinrich
- Geraint Davies (ORCID: https://orcid.org/0000-0002-3819-490X)
- Mark Harrington
- Valentina Alarcon-Guizado
- L. Guglielmetti
- V. Mave
- Patrick P J Phillips
Institutions
- nLIGHT (United States) (US)
- Harvard University (US)
- University of Liverpool (GB)
- University of California, San Francisco (US)
- Treatment Action Group (US)
- Ospedale Sacro Cuore Don Calabria (IT)
- World Health Organization (CH)
- National Department of Health (PG)
- German Center for Infection Research (DE)
- Ministerio de Salud Pública (EC)
- Ministerio de Salud (BO)
- Ministry of Health (MN)
- Johns Hopkins Center for Communication Programs (US)
- Harvard Global Health Institute (US)
- University of San Francisco (US)
- Ludwig-Maximilians-Universität München (DE)
Publication Details
- Journal
- Clinical Infectious Diseases
- Published
- 2026-03-11
- DOI
- https://doi.org/10.1093/cid/ciag175
- Primary Topic
- Tuberculosis Research and Epidemiology
- Type
- article
- Field-Weighted Citation Impact
- 0.00