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How individuals with spinal cord injury in the United States access and assess information about experimental therapies and clinical trials: results of a clinical survey.美国脊髓损伤个体如何获取和评估实验疗法及临床试验信息:一项临床调查结果。
Spinal Cord Ser Cases. 2020 Nov 23;6(1):103. doi: 10.1038/s41394-020-00354-6.
4
The challenge of recruitment for neurotherapeutic clinical trials in spinal cord injury.脊髓损伤神经治疗临床试验招募面临的挑战。
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Clinical Trials Registration and Results Information Submission. Final rule.临床试验注册与结果信息提交。最终规则。
Fed Regist. 2016 Sep 21;81(183):64981-5157.
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Feasibility of patient recruitment into clinical trials of experimental treatments for acute spinal cord injury.急性脊髓损伤实验性治疗临床试验中患者招募的可行性。
J Clin Neurosci. 2012 Oct;19(10):1338-43. doi: 10.1016/j.jocn.2012.02.015. Epub 2012 Aug 24.

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.

DOI:10.1038/s41393-024-00980-z
PMID:38499760
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11003861/
Abstract

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.

摘要

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。