临床试验的伦理和责任。

IF 2.1 4区医学 Q3 CLINICAL NEUROLOGY

Spinal cord Pub Date : 2024-03-18 DOI:10.1038/s41393-024-00980-z

Tanya A. Barretto, Wolfram Tetzlaff, Judy Illes

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引用次数: 0

摘要

2023 年 5 月，ClinicalTrials.gov 网站上发布了一条免责声明，否认对注册信息的准确性负责。就脊髓损伤而言，干预分类、阶段划分的不一致以及研究方案和结果的缺失威胁着数据库的完整性，并给用户带来风险。投资于该资源应该成为什么而不是什么，将赋予其与监管使用要求和未来试验参与者知情决策相称的权威性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Ethics and accountability for clinical trials

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.

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来源期刊

Spinal cord 医学-临床神经学

CiteScore

4.50

自引率

9.10%

发文量

142

审稿时长

2 months

期刊介绍： Spinal Cord is a specialised, international journal that has been publishing spinal cord related manuscripts since 1963. It appears monthly, online and in print, and accepts contributions on spinal cord anatomy, physiology, management of injury and disease, and the quality of life and life circumstances of people with a spinal cord injury. Spinal Cord is multi-disciplinary and publishes contributions across the entire spectrum of research ranging from basic science to applied clinical research. It focuses on high quality original research, systematic reviews and narrative reviews. Spinal Cord''s sister journal Spinal Cord Series and Cases: Clinical Management in Spinal Cord Disorders publishes high quality case reports, small case series, pilot and retrospective studies perspectives, Pulse survey articles, Point-couterpoint articles, correspondences and book reviews. It specialises in material that addresses all aspects of life for persons with spinal cord injuries or disorders. For more information, please see the aims and scope of Spinal Cord Series and Cases.