{
  "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.",
  "abstract_shown": true,
  "affiliations": [
    "Center for Tuberculosis, UCSF Institute for Global Health Sciences, University of California, San Francisco, San Francisco, California, USA",
    "World Health Organization, Geneva, Switzerland",
    "Gates Medical Research Institute, Boston, Massachusetts, USA",
    "Stony Point Life Sciences Consulting LLC, New York, USA",
    "The Aurum Institute, Johannesburg, South Africa",
    "Center for Tuberculosis Research, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America",
    "Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America",
    "School of Public Health, University of Witwatersrand, Johannesburg, South Africa",
    "Department of Medicine, Vanderbilt University, Nashville, TN, USA",
    "Faculty of Health Sciences, University of the Witwatersrand, South Africa",
    "Institute for Infection and Immunity, City St George’s, University of London, UK",
    "University of Liverpool, Liverpool, UK",
    "Medical University of South Carolina, South Carolina, USA",
    "UCL 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",
    "London School of Hygiene and Tropical Medicine, London, UK",
    "Department of Global Health & Social Medicine, Harvard Medical School, Boston, MA, USA",
    "NIH /NIAID, Bethesda, Maryland, USA",
    "Radboud University Medical Center, Nijmegen, The Netherlands",
    "University of St Andrews, St Andrews, UK",
    "Division of HIV, Infectious Diseases, and Global Medicine, University of California, San Francisco, San Francisco, California, USA",
    "Institute 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 (HMGU), Neuerburg, Germany",
    "German Centre for Infection Research, Partner Site Munich, 80799 Munich, Germany",
    "Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology, Infection and Pandemic Research, Türkenstraße 87, 80799 Munich, Germany",
    "French Institute for Research on Sustainable Development (IRD), University of Montpellier, Montpellier, France",
    "FAST-TB Program, CRDF Global, Arlington, VA, USA"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 23,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Patrick P.J. Phillips"
    },
    {
      "affs": [
        1
      ],
      "name": "Samuel G. Schumacher"
    },
    {
      "affs": [
        2
      ],
      "name": "Aparna Anderson"
    },
    {
      "affs": [
        3
      ],
      "name": "Cara Cassino"
    },
    {
      "affs": [
        4
      ],
      "name": "Salome Charalambous"
    },
    {
      "affs": [
        5,
        6
      ],
      "name": "Richard E Chaisson"
    },
    {
      "affs": [
        4,
        7,
        8
      ],
      "name": "Gavin Churchyard"
    },
    {
      "affs": [
        9
      ],
      "name": "Francesca Conradie"
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    {
      "affs": [
        10
      ],
      "name": "Christopher Cousins"
    },
    {
      "affs": [
        11
      ],
      "name": "Gerry Davies"
    },
    {
      "affs": [
        12
      ],
      "name": "Susan E. Dorman"
    },
    {
      "affs": [
        13,
        14
      ],
      "name": "Hanif Esmail"
    },
    {
      "affs": [
        15
      ],
      "name": "Katherine Fielding"
    },
    {
      "affs": [
        16
      ],
      "name": "Carole D. Mitnick"
    },
    {
      "affs": [
        17
      ],
      "name": "David McNeeley"
    },
    {
      "affs": [
        0
      ],
      "name": "Payam Nahid"
    },
    {
      "affs": [
        14
      ],
      "name": "Karen Sanders"
    },
    {
      "affs": [
        18
      ],
      "name": "Jodie A. Schildkraut"
    },
    {
      "affs": [
        18,
        19
      ],
      "name": "Derek Sloan"
    },
    {
      "affs": [
        0,
        20
      ],
      "name": "Gustavo E. Velásquez"
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    {
      "affs": [
        21,
        22,
        23,
        24
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      "name": "Michael Hoelscher"
    },
    {
      "affs": [
        17
      ],
      "name": "Andrew Vernon"
    },
    {
      "affs": [
        25,
        26
      ],
      "name": "Christian Lienhardt"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/eckmsfnepaz0h.bib",
  "cited_by": 1,
  "doi": "10.1016/s1473-3099(26)00359-2",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC7619440/",
  "id": "eckmsfnepaz0h",
  "issns": [
    "1473-3099",
    "1474-4457"
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  "landing_url": "https://doi.org/10.1016/s1473-3099(26)00359-2",
  "language": "en",
  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Article"
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      "openalex",
      "2725|Tuberculosis Research and Epidemiology"
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  "openalex": "W7203467630",
  "pdf_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC7619440/pdf/EMS217862.pdf",
  "pmcid": "PMC7619440",
  "pmid": "42600623",
  "published": "2026-08-14",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/eckmsfnepaz0h.ris",
  "sources": [
    {
      "first_seen": "2026-11-03T12:23:01Z",
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      "url": "https://doi.org/10.1016/s1473-3099(26)00359-2"
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  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2725|Tuberculosis Research and Epidemiology",
      "subfield": "infectious-disease"
    }
  ],
  "title": "Guiding Principles for Pragmatic Randomized Trials of Tuberculosis Treatments",
  "title_text": "Guiding Principles for Pragmatic Randomized Trials of Tuberculosis Treatments",
  "type": "peer-reviewed",
  "updated_at": "2026-11-04T12:20:42Z",
  "url": "https://research.draconitic.com/paper/eckmsfnepaz0h",
  "venue": "The Lancet. Infectious diseases",
  "versions": []
}