Health Administration Department Wolfson Medical Center, Holon, Israel.
Research and Innovation Authority, Wolfson Medical Center, Holon, Israel.
Isr J Health Policy Res. 2024 Oct 24;13(1):62. doi: 10.1186/s13584-024-00643-7.
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".
A total of 3,895 clinical trial records from 2011 to December 2022 were retrieved from the MyTrial platform and subjected to descriptive analysis.
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.
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.
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，《赫尔辛基宣言》要求在招募受试者前对试验进行前瞻性注册。在以色列，MyTrial 注册处于 2015 年成立，用于注册干预性试验，并于 2016 年成为伦理批准的强制性要求。本研究旨在使用当地的 MyTrial 注册表分析以色列临床试验注册的实践、挑战和趋势。
从 MyTrial 平台检索了 2011 年至 2022 年 12 月的 3895 份临床试验记录，并进行了描述性分析。
由于强制性注册，2016 年至 2021 年注册数量显著增加，2020 年达到峰值（733 项试验），2022 年减少（462 项试验），可能与 COVID-19 有关。大多数试验涉及药物（56%）或医疗器械（33%）。从地理位置上看，53%的试验来自以色列中部。只有 39%的患者在 MyTrial 和 ClinicalTrials.gov 上都有登记。65%的试验没有盲法。47%的试验使用未注册的产品。56%的试验尚未开始招募。自 2016 年以来，高级治疗试验的数量稳步增加，2022 年达到 19 项。注册试验和官方政府报告之间存在差距。
这些发现为我们了解以色列目前临床试验注册的现状提供了有价值的信息，并强调了需要提高前瞻性注册的合规性，以及遵守世卫组织国际临床试验注册平台标准的必要性。
