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Implementation of data protection laws in the European Union and in California is associated with a move of clinical trials to countries with fewer data protections

The European Union implemented data privacy laws in mid-2018 and the state of California enacted a similar law several weeks later. These regulations affect medical data collection and analysis. It is unclear if they achieve this goal in the realm of clinical trials. Here we investigate the effect o...

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Autores principales: Yom-Tov, Elad, Ofran, Yishai
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9685308/
https://www.ncbi.nlm.nih.gov/pubmed/36438038
http://dx.doi.org/10.3389/fmed.2022.1051025
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author Yom-Tov, Elad
Ofran, Yishai
author_facet Yom-Tov, Elad
Ofran, Yishai
author_sort Yom-Tov, Elad
collection PubMed
description The European Union implemented data privacy laws in mid-2018 and the state of California enacted a similar law several weeks later. These regulations affect medical data collection and analysis. It is unclear if they achieve this goal in the realm of clinical trials. Here we investigate the effect of these laws on clinical trials through analysis of clinical trials recorded on the US's ClinicalTrials.gov, the World Health Organization's International Clinical Trials Registry Platform and scientific papers describing clinical trials. Our findings show that the number of phase 1 and 2 trials in countries not adhering to these data privacy laws rose significantly after implementation of these laws. The largest rise occurred in countries which are less free, as indicated by the negative correlation (−0.48, p = 0.008) between the civil liberties freedom score of countries and the increase in the number of trials. This trend was not observed in countries adhering to data privacy laws nor in the paper publication record. The rise was larger (and statistically significant) among industry funded trials and interventional trials. Thus, the implementation of data privacy laws is associated a change in the location of clinical trials, which are currently executed more often in countries where people have fewer protections for their data.
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spelling pubmed-96853082022-11-25 Implementation of data protection laws in the European Union and in California is associated with a move of clinical trials to countries with fewer data protections Yom-Tov, Elad Ofran, Yishai Front Med (Lausanne) Medicine The European Union implemented data privacy laws in mid-2018 and the state of California enacted a similar law several weeks later. These regulations affect medical data collection and analysis. It is unclear if they achieve this goal in the realm of clinical trials. Here we investigate the effect of these laws on clinical trials through analysis of clinical trials recorded on the US's ClinicalTrials.gov, the World Health Organization's International Clinical Trials Registry Platform and scientific papers describing clinical trials. Our findings show that the number of phase 1 and 2 trials in countries not adhering to these data privacy laws rose significantly after implementation of these laws. The largest rise occurred in countries which are less free, as indicated by the negative correlation (−0.48, p = 0.008) between the civil liberties freedom score of countries and the increase in the number of trials. This trend was not observed in countries adhering to data privacy laws nor in the paper publication record. The rise was larger (and statistically significant) among industry funded trials and interventional trials. Thus, the implementation of data privacy laws is associated a change in the location of clinical trials, which are currently executed more often in countries where people have fewer protections for their data. Frontiers Media S.A. 2022-11-10 /pmc/articles/PMC9685308/ /pubmed/36438038 http://dx.doi.org/10.3389/fmed.2022.1051025 Text en Copyright © 2022 Yom-Tov and Ofran. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Medicine
Yom-Tov, Elad
Ofran, Yishai
Implementation of data protection laws in the European Union and in California is associated with a move of clinical trials to countries with fewer data protections
title Implementation of data protection laws in the European Union and in California is associated with a move of clinical trials to countries with fewer data protections
title_full Implementation of data protection laws in the European Union and in California is associated with a move of clinical trials to countries with fewer data protections
title_fullStr Implementation of data protection laws in the European Union and in California is associated with a move of clinical trials to countries with fewer data protections
title_full_unstemmed Implementation of data protection laws in the European Union and in California is associated with a move of clinical trials to countries with fewer data protections
title_short Implementation of data protection laws in the European Union and in California is associated with a move of clinical trials to countries with fewer data protections
title_sort implementation of data protection laws in the european union and in california is associated with a move of clinical trials to countries with fewer data protections
topic Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9685308/
https://www.ncbi.nlm.nih.gov/pubmed/36438038
http://dx.doi.org/10.3389/fmed.2022.1051025
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