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.
Changes to an ICH guideline could help drug companies that are being deluged with post-approval safety information to cut down on noisy, low-value data.