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.

CCPA Consumer Privacy Act GDPR - General Data Protection Regulation clinical trials data protection and privacy

Journal

Frontiers in medicine
ISSN: 2296-858X
Titre abrégé: Front Med (Lausanne)
Pays: Switzerland
ID NLM: 101648047

Informations de publication

Date de publication:
2022
Historique:
received: 22 09 2022
accepted: 24 10 2022
entrez: 28 11 2022
pubmed: 29 11 2022
medline: 29 11 2022
Statut: epublish

Résumé

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,

Identifiants

pubmed: 36438038
doi: 10.3389/fmed.2022.1051025
pmc: PMC9685308
doi:

Types de publication

Journal Article

Langues

eng

Pagination

1051025

Informations de copyright

Copyright © 2022 Yom-Tov and Ofran.

Déclaration de conflit d'intérêts

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Références

Nature. 2020 Aug;584(7822):498
pubmed: 32843731
Eur J Pediatr. 2021 May;180(5):1371-1379
pubmed: 33462697
N Engl J Med. 2004 Sep 16;351(12):1250-1
pubmed: 15356289
Nature. 2022 Jun;606(7912):7
pubmed: 35637322
Acta Oncol. 2019 Nov;58(11):1547-1548
pubmed: 31469347
J Med Internet Res. 2020 Aug 27;22(8):e19799
pubmed: 32784191
BMJ. 2018 May 25;361:k1452
pubmed: 29802130
Eur J Hum Genet. 2020 Jun;28(6):697-705
pubmed: 32123329
Eur J Hum Genet. 2019 Aug;27(8):1159-1167
pubmed: 30996335
Eur J Health Law. 2019 Apr 24;26(2):97-119
pubmed: 31059476

Auteurs

Elad Yom-Tov (E)

Microsoft Research Israel, Hertzliya, Israel.
Faculty of Industrial Engineering and Management, Haifa, Israel.

Yishai Ofran (Y)

Hematology and Bone Marrow Transplantation Department, Sharee Zedek Medical Center, Jerusalem, Israel.
Faculty of Medicine Hebrew University of Jerusalem, Jerusalem, Israel.

Classifications MeSH