结核病治疗临床试验的标准
P du Cros1, J Greig2, J-W C Alffenaar3
1Burnet Institute, Melbourne, VIC, Monash Infectious Diseases, Monash Health, Melbourne, VIC, Australia.
概括
实施最佳实践标准可以加强结核病 (TB) 治疗试验. 这些十一项标准旨在改善证据生成,效率以及将研究转化为政策和实践.
科学领域:
- 临床研究 临床研究
- 公共卫生 公共卫生
- 传染性疾病 传染性疾病
背景情况:
- 结核病 (TB) 治疗试验需要提高价值,速度和证据稳定性.
- 实施最佳实践标准对于加强结核病研究至关重要.
研究的目的:
- 定义和建立结核病 (TB) 治疗试验的最佳实践标准.
- 提高结核病研究产生的证据的质量,效率和影响.
主要方法:
- 一个全球专家小组使用了Delphi过程和7点的利克特等级.
- 标准草案被反复评分和修订,以达成共识.
主要成果:
- 定义了结核病治疗试验的11个关键标准.
- 标准涵盖数据质量,社区参与,包容性,高效设计,治理,患者参与,药理动力学/药理动力学成分,结果措施 (复发,后续),协调,生物银行和能力建设.
结论:
- 预计已建立的标准将提高结核病试验中证据生成的效率和有效性.
- 这些标准将有助于将研究成果转化为改善结核病政策和临床实践.
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