报告试验协议和完成试验的指导方针因COVID-19大流行和其他减轻性情况而被修改:CONSERVE 2021声明
Aaron M Orkin1,2, Peter J Gill3, Davina Ghersi4
1Division of Emergency Medicine, Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada.
JAMA
|June 21, 2021
概括
像COVID-19这样的减轻性情况可能会改变随机试验. 为了提高透明度和有效性,CONSERVE指南改善了对这些关键试验修改的报告.
科学领域:
- 临床试验方法
- 研究伦理
- 科学报告标准
背景情况:
- 由于减轻性情况 (例如,COVID-19) 导致随机试验的非计划性修改带来了重大的方法,伦理和分析挑战.
- 现有的报告准则为记录这些重要的试验改变提供了不完整的指导,可能会损害研究的有效性.
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