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Trends in Israeli clinical trials registration "MyTrial"
1Health Administration Department Wolfson Medical Center, Holon, Israel.
Israel Journal of Health Policy Research
|October 25, 2024
Summary
Clinical trial registration in Israel increased after mandatory implementation in 2016. However, compliance with prospective registration and international standards requires improvement for enhanced research transparency.
Area of Science:
- Clinical research
- Health policy
- Medical informatics
Background:
- Clinical trial registration is essential for research transparency and integrity.
- Prospective registration has been required since 2005.
- Israel's MyTrial registry, established in 2015, became mandatory for ethical approval in 2016.
Purpose of the Study:
- To analyze clinical trial registration practices, challenges, and trends in Israel.
- To evaluate the impact of mandatory registration on trial submissions.
- To identify areas for improvement in compliance and adherence to international standards.
Main Methods:
- Descriptive analysis of 3,895 clinical trial records from the MyTrial platform (2011-2022).
Main Results:
- Mandatory registration (from 2016) led to a significant increase in trial submissions, peaking in 2020.
- Most trials involved drugs (56%) or medical devices (33%), with a rise in advanced therapy trials.
- Significant gaps were observed in dual registration (MyTrial and ClinicalTrials.gov), blinding, unregistered products, and alignment with official reports.
Conclusions:
- The study highlights progress in clinical trial registration in Israel post-mandate.
- There is a clear need to enhance compliance with prospective registration and WHO-ICTRP standards.
- Addressing identified gaps is crucial for improving the integrity and transparency of clinical research in Israel.
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