du Cros, P 
ORCID: 0000-0002-3599-029X, Greig, J ORCID: 0000-0003-2732-0023, Alffenaar, J-WC, Cross, GB, Cousins, C ORCID: 0009-0004-9055-509X, Berry, C, Khan, U, Phillips, PPJ, Velásquez, GE ORCID: 0000-0003-1438-0692, Furin, J et al (show 30 more authors)
(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.
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Abstract
<b>BACKGROUND:</b> The value, speed of completion and robustness of the evidence generated by TB treatment trials could be improved by implementing standards for best practice.<b>METHODS:</b> 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.<b>RESULTS:</b> 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.<b>CONCLUSION:</b> These standards should improve the efficiency and effectiveness of evidence generation, as well as the translation of research into policy and practice.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Humans, Tuberculosis, Biological Specimen Banks, Clinical Trials as Topic |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Systems, Molecular and Integrative Biology |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 05 Mar 2024 08:34 |
| Last Modified: | 17 Mar 2024 19:08 |
| DOI: | 10.5588/ijtld.23.0341 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3179123 |
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