Improving the efficiency of drug resistant tuberculosis treatment trials: a time-to-event alternative marker for bacteriological response and adaptive minimization for randomization

Using a model of mycobacterial burden changes over time as an alternative indicator of treatment response, combined with a minimization procedure during the randomization process, significantly reduced the sample size which could, if validated, enhance the efficiency of RR-TB clinical trial design.

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Publication Details

Journal
BMC Medical Research Methodology
Published
2025-11-25
DOI
https://doi.org/10.1186/s12874-025-02697-w
Primary Topic
Tuberculosis Research and Epidemiology
Type
article
Field-Weighted Citation Impact
0.00

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article

Improving the efficiency of drug resistant tuberculosis treatment trials: a time-to-event alternative marker for bacteriological response and adaptive minimization for randomization

Annelies Van Rie, Elise De Vos, Steven Abrams
BMC Medical Research Methodology
Tuberculosis Research and Epidemiology
article

Improving the efficiency of drug resistant tuberculosis treatment trials: a time-to-event alternative marker for bacteriological response and adaptive minimization for randomization

Annelies Van Rie, Elise De Vos, Steven Abrams
article en

Abstract

Using a model of mycobacterial burden changes over time as an alternative indicator of treatment response, combined with a minimization procedure during the randomization process, significantly reduced the sample size which could, if validated, enhance the efficiency of RR-TB clinical trial design.

BMC Medical Research MethodologyVol. 25(1)
University of Antwerp (BE), Province of Antwerp (BE), Instituut voor Tropische Geneeskunde (BE), Hasselt University (BE)
Fonds Wetenschappelijk Onderzoek, Vlaamse regering
Openalex Percentile: Top 57%
Tuberculosis Research and Epidemiology
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Improving the efficiency of drug resistant tuberculosis treatment trials: a time-to-event alternative marker for bacteriological response and adaptive minimization for randomization — Annelies Van Rie, Elise De Vos, et al. · BMC Medical Research Methodology (2025) | TGRS Research Map | TGRS