EU Makes Only Limited Use Of Remote Clinical Trial Monitoring
While regulators worldwide are opening up to the possibility of remote verification of source data from clinical trial sites because of COVID-19 restrictions, this approach is finding less favor in the EU, mainly because of strict data protection rules.
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A senior regulator from the European Medicines Agency says that while the EU General Data Protection Regulation can be intellectually challenging, the law is needed, and it should not deter companies from conducting decentralized clinical trials because of concerns they might have over the use digital tools to capture and process patient and trial data.
The upcoming EU guideline on decentralized clinical trials is the result of a “learning by doing” exercise and builds on various pilots and initiatives launched by different member states.
The COVID-19 pandemic has given a new impetus to Sweden’s ongoing efforts to support decentralized clinical trials.