以色列临床试验注册趋势"MyTrial"
1Health Administration Department Wolfson Medical Center, Holon, Israel.
Israel journal of health policy research
|October 25, 2024
概括
以色列的临床试验注册在2016年强制实施后增加了. 然而,遵守未来的注册和国际标准需要改进,以提高研究透明度.
科学领域:
- 临床研究是临床研究.
- 卫生政策 卫生政策
- 医疗信息学医学信息学
背景情况:
- 临床试验注册对于研究的透明度和完整性至关重要.
- 自2005年以来,需要进行前性注册.
- 2015年成立的以色列MyTrial注册表于2016年成为伦理审批的强制性要求.
研究的目的:
- 分析以色列临床试验注册实践,挑战和趋势.
- 评估强制性注册对试验提交文件的影响.
- 确定需要改进的国际标准的遵守和遵守的领域.
主要方法:
- 来自MyTrial平台 (2011-2022) 的3895个临床试验记录的描述性分析.
主要成果:
- 强制性注册 (从2016年开始) 导致试验提交量大幅增加,在2020年达到顶峰.
- 大多数试验涉及药物 (56%) 或医疗器械 (33%),先进治疗试验的增加.
- 在双重注册 (MyTrial和ClinicalTrials.gov),盲目注册,未注册产品以及与官方报告一致方面观察到重大差距.
结论:
- 该研究强调了以色列在授权后临床试验注册的进展.
- 显然需要加强对未来注册和WHO-ICTRP标准的遵守.
- 解决发现的差距对于改善以色列临床研究的完整性和透明度至关重要.
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