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.
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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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