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Moving from culture-based to simpler- or faster-to-measure biomarkers as efficacy surrogates may enhance this advantage. We performed a systematic review of treatment efficacy biomarkers in adults with tuberculosis. Platform trials can span different development phases. We grouped biomarkers as: \u03b1, bacterial load estimates used in phase 2a trials; \u03b2, early and end-of treatment end points, phase 2b-c trials; \u03b3, posttreatment or trial-level estimates, phase 2c-3 trials. We considered as analysis unit (biomarker entry) each combination of biomarker, predicted outcome, and their respective measurement times or intervals. Performance metrics included: sensitivity, specificity, area under the receiver-operator curve (AUC), and correlation measures, and classified as poor, promising, or good. Eighty-six studies included 22 864 participants. From 1356 biomarker entries, 318 were reported with the performance metrics of interest, with 103 promising and 41 good predictors. Group results were: \u03b1, mycobacterial RNA and lipoarabinomannan (LAM) in sputum, and host metabolites in urine; \u03b2, mycobacterial RNA and host transcriptomic or cytokine signatures for early treatment response; and \u03b3, host transcriptomics for recurrence. A combination of biomarkers from different categories could help in designing more efficient platform trials. Efforts to develop efficacy surrogates should be better coordinated.<\/jats:p>","DOI":"10.1093\/infdis\/jiad482","type":"journal-article","created":{"date-parts":[[2023,11,13]],"date-time":"2023-11-13T18:02:16Z","timestamp":1699898536000},"page":"1584-1595","source":"Crossref","is-referenced-by-count":6,"title":["A Systematic Review of Potential Biomarkers for Bacterial Burden and Treatment Efficacy Assessment in Tuberculosis Platform-Based Clinical Trials"],"prefix":"10.1093","volume":"229","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7238-8337","authenticated-orcid":false,"given":"Juan","family":"Espinosa-Pereiro","sequence":"first","affiliation":[{"name":"Infectious Diseases Department, Vall d\u2019Hebr\u00f3n University Hospital, Universitat Aut\u00f3noma de Barcelona , Barcelona , Spain"},{"name":"International Health Program, Catalan Institute of Health , Barcelona , Spain"},{"name":"Centro de Investigaci\u00f3n Biom\u00e9dica en Red de Enfermedades Infeccioass, Instituto 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Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9252-7106","authenticated-orcid":false,"given":"Norbert","family":"Heinrich","sequence":"additional","affiliation":[{"name":"Center for International Health, University Hospital, Ludwig Maximilian University Munich , Munich , Germany"},{"name":"German Center for Infection Research , Munich , Germany"},{"name":"Division of Infectious Diseases and Tropical Medicine, University Hospital, Ludwig Maximilian University Munich (DZIF), Partner Site Munich, Munich , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2194-5447","authenticated-orcid":false,"given":"Adri\u00e1n","family":"S\u00e1nchez-Montalv\u00e1","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department, Vall d\u2019Hebr\u00f3n University Hospital, Universitat Aut\u00f3noma de Barcelona , Barcelona , Spain"},{"name":"International Health Program, Catalan 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