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Peer-reviewedCC BY 4.0The Lancet. Infectious diseases

Guiding Principles for Pragmatic Randomized Trials of Tuberculosis Treatments

  • Patrick P.J. Phillips1
  • Samuel G. Schumacher2
  • Aparna Anderson3
  • Cara Cassino4
  • Salome Charalambous5
  • Richard E Chaisson6,7
  • Gavin Churchyard5,8,9
  • Francesca Conradie10
  • Christopher Cousins11
  • Gerry Davies12
  • Susan E. Dorman13
  • Hanif Esmail14,15
11 more authors
  • Katherine Fielding16
  • Carole D. Mitnick17
  • David McNeeley18
  • Payam Nahid1
  • Karen Sanders15
  • Jodie A. Schildkraut19
  • Derek Sloan19,20
  • Gustavo E. Velásquez1,21
  • Michael Hoelscher22,23,24,25
  • Andrew Vernon18
  • Christian Lienhardt26,27
27 affiliations
  1. 1Center for Tuberculosis, UCSF Institute for Global Health Sciences, University of California, San Francisco, San Francisco, California, USA
  2. 2World Health Organization, Geneva, Switzerland
  3. 3Gates Medical Research Institute, Boston, Massachusetts, USA
  4. 4Stony Point Life Sciences Consulting LLC, New York, USA
  5. 5The Aurum Institute, Johannesburg, South Africa
  6. 6Center for Tuberculosis Research, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America
  7. 7Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America
  8. 8School of Public Health, University of Witwatersrand, Johannesburg, South Africa
  9. 9Department of Medicine, Vanderbilt University, Nashville, TN, USA
  10. 10Faculty of Health Sciences, University of the Witwatersrand, South Africa
  11. 11Institute for Infection and Immunity, City St George’s, University of London, UK
  12. 12University of Liverpool, Liverpool, UK
  13. 13Medical University of South Carolina, South Carolina, USA
  14. 14UCL Centre for Global Tuberculosis Research and WHO Collaborating Centre for Tuberculosis Research and Innovation, University College London, London, UK
  15. 15UCL Innovative Clinical Trials Unit, University College London, London, UK
  16. 16London School of Hygiene and Tropical Medicine, London, UK
  17. 17Department of Global Health & Social Medicine, Harvard Medical School, Boston, MA, USA
  18. 18NIH /NIAID, Bethesda, Maryland, USA
  19. 19Radboud University Medical Center, Nijmegen, The Netherlands
  20. 20University of St Andrews, St Andrews, UK
  21. 21Division of HIV, Infectious Diseases, and Global Medicine, University of California, San Francisco, San Francisco, California, USA
  22. 22Institute of Infectious Diseases and Tropical Medicine, LMU University Hospital, LMU Munich, Munich, Germany
  23. 23Unit Global Health, Helmholtz Zentrum München, German Research Center for Environmental Health (HMGU), Neuerburg, Germany
  24. 24German Centre for Infection Research, Partner Site Munich, 80799 Munich, Germany
  25. 25Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology, Infection and Pandemic Research, Türkenstraße 87, 80799 Munich, Germany
  26. 26French Institute for Research on Sustainable Development (IRD), University of Montpellier, Montpellier, France
  27. 27FAST-TB Program, CRDF Global, Arlington, VA, USA
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Abstract

Tuberculosis (TB) remains a major global health challenge, despite recent advances in drug and regimen development. Pragmatic randomized trials are needed to evaluate the effectiveness, safety, and tolerability of TB treatments under routine care conditions to appropriately inform practice guidelines and facilitate uptake. We propose guiding principles for pragmatic TB treatment trials. Using the PRECIS-2 framework, we address eligibility, recruitment, setting, organization of care, adherence support, outcomes, follow-up, primary analysis, data collection, and monitoring. Pragmatic trials should maximize generalizability through broad inclusion criteria, integration within routine health systems, and flexible delivery approaches while maintaining appropriate standards for participant safety, laboratory quality, and data reliability. We discuss considerations for individually randomized and cluster-randomized 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 TB treatments.

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Cite

BibTeXRIS
BibTeX
@article{phillips2026guiding,
  title = {{Guiding Principles for Pragmatic Randomized Trials of Tuberculosis Treatments}},
  author = {Patrick P.J. Phillips and Samuel G. Schumacher and Aparna Anderson and Cara Cassino and Salome Charalambous and Richard E Chaisson and Gavin Churchyard and Francesca Conradie and Christopher Cousins and Gerry Davies and Susan E. Dorman and Hanif Esmail and Katherine Fielding and Carole D. Mitnick and David McNeeley and Payam Nahid and Karen Sanders and Jodie A. Schildkraut and Derek Sloan and Gustavo E. Velásquez and Michael Hoelscher and Andrew Vernon and Christian Lienhardt},
  journal = {The Lancet. Infectious diseases},
  year = {2026},
  month = aug,
  doi = {10.1016/s1473-3099(26)00359-2},
  url = {https://doi.org/10.1016/s1473-3099(26)00359-2},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Guiding Principles for Pragmatic Randomized Trials of Tuberculosis Treatments
AU  - Patrick P.J. Phillips
AU  - Samuel G. Schumacher
AU  - Aparna Anderson
AU  - Cara Cassino
AU  - Salome Charalambous
AU  - Richard E Chaisson
AU  - Gavin Churchyard
AU  - Francesca Conradie
AU  - Christopher Cousins
AU  - Gerry Davies
AU  - Susan E. Dorman
AU  - Hanif Esmail
AU  - Katherine Fielding
AU  - Carole D. Mitnick
AU  - David McNeeley
AU  - Payam Nahid
AU  - Karen Sanders
AU  - Jodie A. Schildkraut
AU  - Derek Sloan
AU  - Gustavo E. Velásquez
AU  - Michael Hoelscher
AU  - Andrew Vernon
AU  - Christian Lienhardt
PY  - 2026
DA  - 2026/08/14
JO  - The Lancet. Infectious diseases
DO  - 10.1016/s1473-3099(26)00359-2
UR  - https://doi.org/10.1016/s1473-3099(26)00359-2
AB  - Tuberculosis (TB) remains a major global health challenge, despite recent advances in drug and regimen development. Pragmatic randomized trials are needed to evaluate the effectiveness, safety, and tolerability of TB treatments under routine care conditions to appropriately inform practice guidelines and facilitate uptake. We propose guiding principles for pragmatic TB treatment trials. Using the PRECIS-2 framework, we address eligibility, recruitment, setting, organization of care, adherence support, outcomes, follow-up, primary analysis, data collection, and monitoring. Pragmatic trials should maximize generalizability through broad inclusion criteria, integration within routine health systems, and flexible delivery approaches while maintaining appropriate standards for participant safety, laboratory quality, and data reliability. We discuss considerations for individually randomized and cluster-randomized 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 TB treatments.
SN  - 1473-3099
SN  - 1474-4457
ER  -