Standards for clinical trials for treating TB.
Standards for clinical trials for treating TB.
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DOI：
10.5588/ijtld.23.0341
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发表时间：
2023-12-01
期刊：
影响因子：
--
通讯作者：
Marais BJ
中科院分区：
文献类型：
--
作者：
du Cros P;Greig J;Alffenaar JC;Cross GB;Cousins C;Berry C;Khan U;Phillips PPJ;Velásquez GE;Furin J;Spigelman M;Denholm JT;Thi SS;Tiberi S;Huang GKL;Marks GB;Turkova A;Guglielmetti L;Chew KL;Nguyen HT;Ong CWM;Brigden G;Singh KP;Motta I;Lange C;Seddon JA;Nyang'wa BT;Maug AKJ;Gler MT;Dooley KE;Quelapio M;Tsogt B;Menzies D;Cox V;Upton CM;Skrahina A;McKenna L;Horsburgh CR;Dheda K;Marais BJ
通过实施最佳做法标准，可以提高结核病治疗试验产生的证据的价值、完成速度和可靠性。一个全球专家小组参加了一个德尔菲过程，使用7分制的李克特量表对标准草案进行评分和修订，直到达成共识。确定了11项标准：标准1，关于结核治疗方案的高质量数据对于为临床和规划管理提供信息至关重要;标准2，结核试验所解决的研究问题应与受影响社区相关，这些社区应被纳入所有试验阶段;标准3，试验应尽一切努力尽可能具有包容性;标准4，应考虑最有效的审判设计，以便在不影响质量的情况下，尽可能迅速和具有成本效益地改进证据基础;标准5，试验管理应符合公认的良好临床实践;标准6，试验应调查和报告促进最佳参与护理的策略;标准7，在可能的情况下，结核病试验应包括药代动力学和药效学部分;标准8，结果应包括疾病复发和治疗后后遗症的频率;标准9，结核病试验应旨在协调各项研究的关键结果和数据结构;标准10，结核病试验应包括生物库;标准11，治疗试验应投资于加强当地试验和结核病规划工作人员的能力。这些标准应提高证据生成的效率和效力，并将研究成果转化为政策和实践。
The value, speed of completion and robustness of the evidence generated by TB treatment trials could be improved by implementing standards for best practice. 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. 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. These standards should improve the efficiency and effectiveness of evidence generation, as well as the translation of research into policy and practice.
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影响因子：
2.5
作者：
Carrion Martin, A. I.;Derrough, T.;Jansa, J. M.
通讯作者：
Jansa, J. M.
影响因子：
158.5
作者：
Conradie, Francesca;Diacon, Andreas H.;Spigelman, Melvin
通讯作者：
Spigelman, Melvin
影响因子：
11.8
作者：
Alffenaar, Jan-Willem C.;Gumbo, Tawanda;Migliori, Giovanni Battista
通讯作者：
Migliori, Giovanni Battista
贝达喹啉-Pretomanid-利奈唑胺治疗耐药结核病的方案。
DOI：
10.1056/nejmoa2119430
发表时间：
2022-09-01
期刊：
The New England journal of medicine
影响因子：
--
作者：
通讯作者：
--
影响因子：
5.2
作者：
Bateson, Anna;Canseco, Julio Ortiz;McHugh, Timothy D.;Witney, Adam A.;Feuerriegel, Silke;Merker, Matthias;Kohl, Thomas A.;Utpatel, Christian;Niemann, Stefan;Andres, Sonke;Kranzer, Katharina;Maurer, Florian P.;Ghodousi, Arash;Borroni, Emanuele;Cirillo, Daniela Maria;Wijkander, Maria;Toro, Juan C.;Groenheit, Ramona;Werngren, Jim;Machado, Diana;Viveiros, Miguel;Warren, Robin M.;Sirgel, Frederick;Dippenaar, Anzaan;Koeser, Claudio U.;Sun, Eugene;Timm, Juliano
通讯作者：
Timm, Juliano