临床试验的伦理与责任。
Ethics and accountability for clinical trials.
机构信息
Neuroethics Canada, Division of Neurology, Department of Medicine, University of British Columbia, Vancouver, BC, Canada.
International Collaboration on Repair Discoveries (ICORD), University of British Columbia, Vancouver, BC, Canada.
出版信息
Spinal Cord. 2024 Apr;62(4):192-194. doi: 10.1038/s41393-024-00980-z. Epub 2024 Mar 18.
In May 2023, a disclaimer posted on ClinicalTrials.gov dismisses accountability for the accuracy of registered information. For spinal cord injury, inconsistencies in intervention classification, phase designation, and lack of study protocols and results threaten the integrity of the database and put users at risk. An investment in what the resource should be rather than what it is not will give it the authority commensurate with the requirements for its regulatory use and informed decision-making for prospective trial participants.
2023 年 5 月，ClinicalTrials.gov 上发布了一则免责声明，免除了对注册信息准确性的责任。对于脊髓损伤，干预分类、阶段指定以及缺乏研究方案和结果的不一致性，威胁到数据库的完整性，并使用户面临风险。对资源应该是什么而不是不是什么进行投资，将赋予它与监管使用要求和未来试验参与者知情决策相称的权威。
Zotero 插件