The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2023
Standards for clinical trials for treating TB.
СтатьяПоддержка службы здравоохранения СШАПоддержка NIH: внешняя программаПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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du Cros P, Greig J, Alffenaar J-W C, Cross G B, Cousins C, Berry C, Khan U, Phillips P P J, Velásquez G E, Furin J, Spigelman M, Denholm J T, Thi S S, Tiberi S, Huang G K L, Marks G B, Turkova A, Guglielmetti L, Chew K L, Nguyen H T, Ong C W M, Brigden G, Singh K P, Motta I, Lange C, Seddon J A, Nyang'wa B-T, Maug A K J, Gler M T, Dooley K E, Quelapio M, Tsogt B, Menzies D, Cox V, Upton C M, Skrahina A, McKenna L, Horsburgh C R, Dheda K, Marais B J
Аннотация
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.