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Standards for clinical trials for treating TB

du Cros, P; Greig, J; Alffenaar, JWC; Cross, GB; Cousins, C; Berry, C; Khan, U; ... Marais, BJ; + view all (2023) Standards for clinical trials for treating TB. The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease , 27 (12) pp. 885-898. 10.5588/ijtld.23.0341. Green open access

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Abstract

BACKGROUND: The value, speed of completion and robustness of the evidence generated by TB treatment trials could be improved by implementing standards for best practice.METHODS: A global panel of experts participated in a Delphi process, using a 7-point Likert scale to score and revise draft standards until consensus was reached.RESULTS: 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 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, 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 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 invest in capacity strengthening of local trial and TB programme staff.CONCLUSION: These standards should improve the efficiency and effectiveness of evidence generation, as well as the translation of research into policy and practice.

Type: Article
Title: Standards for clinical trials for treating TB
Location: France
Open access status: An open access version is available from UCL Discovery
DOI: 10.5588/ijtld.23.0341
Publisher version: https://doi.org/10.5588/ijtld.23.0341
Language: English
Additional information: This article is Open Access under the terms of the Creative Commons CC BY licence. (https://creativecommons.org/licenses/by/4.0/)
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
URI: https://discovery.ucl.ac.uk/id/eprint/10183662
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