Crossmark

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

Crossref DOI link: https://doi.org/10.1186/s12874-025-02697-w

Published Online: 2025-11-25

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

De Vos, Elise

Van Rie, Annelies

Abrams, Steven
Funding

Funding for this research was provided by:

Research Foundation Flanders (FWO) Odysseus grant (G0F8316N)

Research Foundation Flanders (FWO) for Applied biomedical research with a primary social finality grant (T001018N)
License Information

Text and Data Mining valid from 2025-11-25

Version of Record valid from 2025-11-25
More Information

Article History

Received: 26 December 2024

Accepted: 30 September 2025

First Online: 25 November 2025

Declarations

:

: The SMARTT trial received ethical approval from the ethics committees of the University of the Free State Health Sciences Research Ethics Committee (UFS-HSD2019/0364/2004), Stellenbosch University Health Research Ethics Committee (N19/07/100), and the University of Antwerp (21/18/239). Written, informed consent to participate was obtained from all piloting participants. The EXIT-RIF study was approved by the Human Research Ethics Committee of the University of the Witwatersrand in South Africa (M111139) and the Institutional Review Board of the University of North Carolina at Chapel Hill in the United States (11-2273) and was conducted in accordance with the ethical principles of the Declaration of Helsinki. Approval of study activities was obtained from relevant health authorities. Participants gave verbal consent by phone (recorded). Waiver of consent was obtained for patients who had died or were LTFU from TB care prior to study enrolment and could not be contacted despite multiple attempts.

: Not applicable.

: The authors declare no competing interests.

Document is current

Any future updates will be listed below