Evidence map›Paper›PMID 41823882›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2026

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

Lindsay McKenna, Mike Frick, Valentina A Alarcón-Guizado, Geraint R Davies, Jennifer J Furin, Lorenzo Guglielmetti, Norbert Heinrich, Marcus Low, Mariama Mahmoud, Vidya Mave and 5 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Lindsay McKennaTuberculosis Project, Treatment Action Group, New York, New York, USA.
Mike FrickTuberculosis Project, Treatment Action Group, New York, New York, USA.ORCID 0000-0002-3316-1930
Valentina A Alarcón-GuizadoDirección de Prevención y Control de Tuberculosis, Dirección General de Intervenciones Estratégicas en Salud Pública, Ministerio de Salud, Lima, Peru.
Geraint R DaviesDepartment of Clinical Infection, Microbiology and Immunology, Institute of Infection, Veterinary and Ecological Sciences, University of Liverpool, Liverpool, United Kingdom.ORCID 0000-0002-3819-490X
Jennifer J FurinDepartment of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA.
Lorenzo GuglielmettiDepartment of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, Verona, Italy.ORCID 0000-0003-0886-9635
Norbert HeinrichGerman Center for Infection Research, Munich Partner Site, Institute of Infectious Diseases and Tropical Medicine, LMU University Hospital, LMU Munich, Munich, Germany.ORCID 0000-0001-9252-7106
Marcus LowSpotlight, Cape Town, South Africa.ORCID 0000-0002-4325-2297
Mariama MahmoudNational Leprosy and Tuberculosis Control Program, Ministry of Health, Freetown, Sierra Leone.ORCID 0009-0000-0782-1934
Vidya MaveCenter for Infectious Diseases in India, Johns Hopkins India, Pune, India.ORCID 0000-0001-8509-4517
Norbert NdjekaSchool of Medicine, Division of Infectious Diseases, Johns Hopkins University, Baltimore, Maryland, USA.
Patrick P J PhillipsUniversity of California SanFrancisco Center for Tuberculosis, University of California San Francisco, San Francisco, California, USA.ORCID 0000-0002-6336-7024
Samuel SchumacherGlobal Programme on Tuberculosis and Lung Health, World Health Organization, Geneva, Switzerland.
Mark HarringtonTreatment Action Group, New York, New York, USA.
Carole D MitnickDepartment of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, Verona, Italy.ORCID 0000-0002-3455-658X

Funding

Fondi Ricerca CorrenteIRCCSItalian Ministry of HealthL. G.Sacro Cuore Don Calabria Hospital
6 · The paper itself

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.

Indexed as

Antitubercular AgentsClinical Trials as TopicClinical Trials, Phase III as TopicTuberculosisAcquired Immunodeficiency SyndromeHumansResearch DesignAntitubercular Agentsevidencehigh evidentiary standardsinternally controlled trialsrandomizedtuberculosis

Identifiers

PMID41823882
PMCPMC13537119

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.