Trends in Israeli clinical trials registration "MyTrial".

IF 3.5 4区 医学 Q1 HEALTH POLICY & SERVICES Israel Journal of Health Policy Research Pub Date : 2024-10-24 DOI:10.1186/s13584-024-00643-7
Anat Engel, Ornit Cohen
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Abstract

Background: Clinical trial registration is critical for research transparency and integrity. Since 2005, the Declaration of Helsinki has required prospective registration of trials before subject recruitment. In Israel, the MyTrial registry was established in 2015 to register interventional trials and became mandatory in 2016 for ethical approval. The study aimed to analyze the registration practices, challenges, and trends in clinical trial registration in Israel using the local registry "MyTrial".

Methods: A total of 3,895 clinical trial records from 2011 to December 2022 were retrieved from the MyTrial platform and subjected to descriptive analysis.

Results: A significant increase occurred from 2016 to 2021 due to mandated registration, with a peak in 2020 (733 trials) and a decrease in 2022 (462 trials), likely due to COVID-19. Most of the trials included drugs (56%) or medical devices (33%). Geographically, 53% were from central Israel. Only 39% of the patients were registered at both MyTrial and ClinicalTrials.gov. 65% had no blinding. 47% featured unregistered products. 56% had not started recruitment. Since 2016, the number of advanced therapy trials has steadily increased, reaching 19 in 2022. There are gaps between registered trials and official government reports.

Conclusion: These findings provide valuable insights into the current landscape of clinical trial registration in Israel and highlight the need for improvements in compliance with prospective registration and adherence to the WHO-ICTRP standards.

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以色列临床试验注册 "MyTrial "的趋势。
背景:临床试验注册对于研究的透明度和完整性至关重要。自 2005 年起,《赫尔辛基宣言》就要求在招募受试者之前对试验进行前瞻性注册。在以色列,MyTrial 登记处于 2015 年建立,用于登记介入性试验,并于 2016 年成为伦理审批的强制性规定。本研究旨在分析以色列利用当地注册机构 "MyTrial "进行临床试验注册的做法、挑战和趋势:方法:从 "MyTrial "平台检索了2011年至2022年12月的3895条临床试验记录,并进行了描述性分析:由于强制注册,2016年至2021年的临床试验数量大幅增加,2020年达到高峰(733项试验),2022年有所减少(462项试验),这可能是由于COVID-19的影响。大多数试验包括药物(56%)或医疗器械(33%)。从地域上看,53%的试验来自以色列中部。只有39%的患者同时在MyTrial和ClinicalTrials.gov上注册。65%的试验没有盲法。47%的患者使用未注册产品。56%尚未开始招募。自2016年以来,晚期治疗试验的数量稳步增长,2022年达到19项。注册试验与官方政府报告之间存在差距:这些发现为了解以色列临床试验注册的现状提供了有价值的见解,并强调了改进前瞻性注册和遵守世界卫生组织-ICTRP标准的必要性。
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来源期刊
CiteScore
6.20
自引率
4.40%
发文量
38
审稿时长
28 weeks
期刊最新文献
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