EMA: ‘No Going Back’ On Decentralized Trials
A senior official from the European Medicines Agency says the COVID-19 pandemic has changed the future clinical trials landscape for good.
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The Danish medicines regulator has set out its expectations on key elements of decentralized clinical trials as part of Denmark’s ongoing effort to develop a robust regulatory framework in this area.
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.
The International Council for Harmonisation has delivered the first of a two-part project to modernize the international good clinical practice framework by finalizing changes to its primary efficacy guideline.