{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T11:14:42Z","timestamp":1789643682647,"version":"4.0.0"},"reference-count":0,"publisher":"International Union Against Tuberculosis and Lung Disease","issue":"12","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["int j tuberc lung dis"],"published-print":{"date-parts":[[2023,12,1]]},"abstract":"<jats:p>\n                    <jats:bold>BACKGROUND:<\/jats:bold>\n                    The value, speed of completion and robustness of the evidence generated by TB treatment trials could be improved by implementing standards for best practice.\n                    <jats:bold>METHODS:<\/jats:bold>\n                    A global panel of experts participated in a Delphi process, using a 7-point Likert scale\n to score and revise draft standards until consensus was reached.\n                    <jats:bold>RESULTS:<\/jats:bold>\n                    Eleven standards were defined: Standard 1, high quality data on TB regimens are essential to inform clinical and programmatic management; Standard 2, the research questions addressed by TB trials should be\n relevant to affected communities, who should be included in all trial stages; Standard 3, trials should make every effort to be as inclusive as possible; Standard 4, the most efficient trial designs should be considered to improve the evidence base as quickly and cost effectively as possible,\n without compromising quality; Standard 5, trial governance should be in line with accepted good clinical practice; Standard 6, trials should investigate and report strategies that promote optimal engagement in care; Standard 7, where possible, TB trials should include pharmacokinetic and pharmacodynamic\n components; Standard 8, outcomes should include frequency of disease recurrence and post-treatment sequelae; Standard 9, TB trials should aim to harmonise key outcomes and data structures across studies; Standard 10, TB trials should include biobanking; Standard 11, treatment trials should\n invest in capacity strengthening of local trial and TB programme staff.\n                    <jats:bold>CONCLUSION:<\/jats:bold>\n                    These standards should improve the efficiency and effectiveness of evidence generation, as well as the translation of research into policy and practice.\n                  <\/jats:p>","DOI":"10.5588\/ijtld.23.0341","type":"journal-article","created":{"date-parts":[[2023,12,2]],"date-time":"2023-12-02T23:30:35Z","timestamp":1701559835000},"page":"885-898","source":"Crossref","is-referenced-by-count":8,"title":["Standards for clinical trials for treating TB"],"prefix":"10.5588","volume":"27","author":[{"given":"P.","family":"du Cros","sequence":"first","affiliation":[{"name":"Burnet Institute, Melbourne, VIC, Monash Infectious Diseases, Monash Health, Melbourne, VIC, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Greig","sequence":"additional","affiliation":[{"name":"Burnet Institute, Melbourne, VIC, M\u00e9decins Sans Fronti\u00e8res (MSF), Manson Unit, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.-W. C.","family":"Alffenaar","sequence":"additional","affiliation":[{"name":"Sydney Infectious Diseases Institute (Sydney ID), and, School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Westmead Hospital, Sydney, NSW"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G. B.","family":"Cross","sequence":"additional","affiliation":[{"name":"Burnet Institute, Melbourne, VIC, Kirby Institute, University of New South Wales, Sydney, NSW, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.","family":"Cousins","sequence":"additional","affiliation":[{"name":"Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, Institute of Clinical Trials and Methodology, University College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.","family":"Berry","sequence":"additional","affiliation":[{"name":"M\u00e9decins Sans Fronti\u00e8res (MSF), Manson Unit, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"U.","family":"Khan","sequence":"additional","affiliation":[{"name":"Interactive Research and Development Global, Singapore City, Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P. P. J.","family":"Phillips","sequence":"additional","affiliation":[{"name":"UCSF Center for Tuberculosis, Division of Pulmonary and Critical Care Medicine, and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G. E.","family":"Vel\u00e1squez","sequence":"additional","affiliation":[{"name":"UCSF Center for Tuberculosis, Division of HIV, Infectious Diseases, and Global Medicine, University of California, San Francisco, San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Furin","sequence":"additional","affiliation":[{"name":"Harvard Medical School, Department of Global Health and Social Medicine, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Spigelman","sequence":"additional","affiliation":[{"name":"Global Alliance for TB Drug Development, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. 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