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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...
Autores principales: | , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2022
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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. |
format | Online Article Text |
id | pubmed-9685308 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
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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