Evidence map›Paper›PMID 42600623›Full record

ReviewThe Lancet. Infectious diseases2026

Guiding principles for pragmatic randomised trials of tuberculosis treatments.

Patrick P J Phillips, Samuel G Schumacher, Cara Cassino, Salome Charalambous, Richard E Chaisson, Gavin J Churchyard, Francesca Conradie, Christopher Cousins, Geraint Davies, Susan E Dorman and 12 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in The Lancet. Infectious diseases, 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

22 authors.

Patrick P J PhillipsCenter for Tuberculosis, UCSF Institute for Global Health Sciences, University of California, San Francisco, San Francisco, CA, USA. Electronic address: patrick.phillips@ucsf.edu.
Samuel G SchumacherWHO, Geneva, Switzerland.
Cara CassinoStony Point Life Sciences Consulting, Benson, VT, USA.
Salome CharalambousThe Aurum Institute, Johannesburg, South Africa; School of Public Health, University of Witwatersrand, Johannesburg, South Africa; Department of Medicine, Vanderbilt University, Nashville, TN, USA.
Richard E ChaissonCenter for Tuberculosis Research, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Gavin J ChurchyardThe Aurum Institute, Johannesburg, South Africa; School of Public Health, University of Witwatersrand, Johannesburg, South Africa; Department of Medicine, Vanderbilt University, Nashville, TN, USA.
Francesca ConradieDepartment of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Christopher CousinsInstitute for Infection and Immunity, City St George's, University of London, London, UK.
Geraint DaviesDepartment of Clinical Infection, Microbiology and Immunology, University of Liverpool, Liverpool, UK.
Susan E DormanMedical University of South Carolina, Charleston, SC, USA.
Hanif EsmailUCL Centre for Global Tuberculosis Research and WHO Collaborating Centre for Tuberculosis Research and Innovation, University College London, London, UK; UCL Innovative Clinical Trials Unit, University College London, London, UK.
Katherine FieldingLondon School of Hygiene and Tropical Medicine, London, UK.
Carole D MitnickDepartment of Global Health & Social Medicine, Harvard Medical School, Boston, MA, USA.
David McNeeleyNational Institutes of Health/ National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.
Payam NahidCenter for Tuberculosis, UCSF Institute for Global Health Sciences, University of California, San Francisco, San Francisco, CA, USA.
Karen SandersUCL Innovative Clinical Trials Unit, University College London, London, UK.
Jodie A SchildkrautDepartment of Pulmonary Disease, Radboud University Medical Center, Nijmegen, Netherlands.
Derek J SloanDepartment of Pulmonary Disease, Radboud University Medical Center, Nijmegen, Netherlands; School of Medicine, University of St Andrews, St Andrews, UK.
Gustavo E VelásquezCenter for Tuberculosis, UCSF Institute for Global Health Sciences, University of California, San Francisco, San Francisco, CA, USA; Division of HIV, Infectious Diseases, and Global Medicine, University of California, San Francisco, San Francisco, CA, USA.
Michael HoelscherInstitute of Infectious Diseases and Tropical Medicine, LMU University Hospital, LMU Munich, Munich, Germany; Unit Global Health, Helmholtz Zentrum München, German Research Center for Environmental Health, Neuerburg, Germany; German Centre for Infection Research, Partner Site Munich, Munich, Germany; Fraunhofer Institute for Translational Medicine and Pharmacology, Immunology, Infection and Pandemic Research, Munich, Germany.
Andrew A VernonNational Institutes of Health/ National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.
Christian LienhardtFrench Institute for Research on Sustainable Development, University of Montpellier, Montpellier, France; FAST-TB Program, CRDF Global, Arlington, VA, USA.

Funding

Aurum Clinical Trials UnitUM1AI154463 · NIAID · AURUM INSTITUTE NPC · PI Gavin John Churchyard · 2021 to 2026
$8.1M
Multidisciplinary Clinical Research and Mentoring in Tuberculosis DiagnosticsK24AI104830 · NIAID · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI DORMAN, SUSAN E · 2015 to 2019
$790k
NIAID NIH HHS K24 AI104830NIAID NIH HHS UM1 AI154463
6 · The paper itself

Abstract

Tuberculosis remains a major global health challenge, despite recent advances in drug and regimen development. Pragmatic randomised trials are needed to evaluate the effectiveness, safety, and tolerability of new tuberculosis treatments under routine care conditions to appropriately inform practice guidelines and facilitate uptake. In this Review, we propose guiding principles for pragmatic tuberculosis treatment trials. Using the PRECIS-2 framework, we address eligibility, recruitment, setting, organisation of care, adherence support, outcomes, follow-up, primary analysis, data collection, and monitoring. Pragmatic trials should maximise generalisability through broad inclusion criteria, integration within routine health systems, and flexible delivery approaches while maintaining appropriate standards for participant safety and data reliability. We discuss considerations for individually randomised and cluster-randomised designs, outcome definitions, risk-proportionate monitoring, and streamlined data collection. Adoption of these principles will improve the generation of real-world evidence and facilitate global implementation of effective tuberculosis treatments.

Identifiers

PMID42600623
PMCPMC7619440

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.