P du Cros, J Greig, J-W C Alffenaar, G B Cross, C Cousins, C Berry, U Khan, P P J Phillips, G E Velásquez, J Furin, M Spigelman, J T Denholm, S S Thi, S Tiberi, G K L Huang, G B Marks, A Turkova, L Guglielmetti, K L Chew, H T Nguyen, C W M Ong, G Brigden, K P Singh, I Motta, C Lange, J A Seddon, B-T Nyang'wa, A K J Maug, M T Gler, K E Dooley, M Quelapio, B Tsogt, D Menzies, V Cox, C M Upton, A Skrahina, L McKenna, C R Horsburgh, K Dheda, B J Marais
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...
December 1, 2023: International Journal of Tuberculosis and Lung Disease