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. 2024 Oct 24;13(1):62.
doi: 10.1186/s13584-024-00643-7.

Trends in Israeli clinical trials registration "MyTrial"

Anat Engel  1 , Ornit Cohen  2
Affiliations

Trends in Israeli clinical trials registration "MyTrial"

Anat Engel et al. Isr J Health Policy Res. .

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.

Keywords: Clinical trials; ClinicalTrials.gov; Israel; MyTrial; Registry.

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Conflict of interest statement

The authors have no conflicts of interest relevant to this article to disclose. There are no prior publications or submissions with any overlapping information, including studies and patients.

Figures

Fig. 1
Fig. 1
Trials registration trend in the Clinical Trials Registry of Israel. Number of retrospective and prospective registrations on MyTrial by year. We conducted a descriptive analysis of the trials registered in MyTrial and showed the number of trials registered per year on the x-axis. The y-axis represents the number of trials out of the Total
Fig. 2
Fig. 2
Subtyping the n of studies by their type of intervention per year. Subtyping the number of studies by their type per year, it appeared that the most common trials were medical device trials. The average indicates that every year, 295 ± 76 of the studies in the MyTrial Platform are new investigational drugs, 182 ± 75 are medical devices, 13 ± 6 are advanced therapies, and 42 ± 25 are no investigational products
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