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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

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish GB
Article number1051025
JournalFrontiers in Medicine
Volume9
DOIs
StatePublished - 10 Nov 2022
Externally publishedYes

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

  1. SDG 16 - Peace, Justice and Strong Institutions
    SDG 16 Peace, Justice and Strong Institutions

Keywords

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

ASJC Scopus subject areas

  • General Medicine

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