Denmark Finds Sponsors ‘Overburdening’ Study Sites To Support Decentralized Trials

Inspections, Scientific Advice Procedures Reveal Multiple Challenges

A senior Danish GCP Inspector highlights instances of clinical trial sites facing burdensome procedures to support decentralized trials and discusses other challenges posed by such studies.

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DCTs should neither compromise patient safety and data integrity, nor result in increased burden at trial sites • Source: Alamy

Decentralized trials (DCTs) can make research faster and more efficient as they allow all or most trial activities to be done remotely in or near a patient’s home. However, if not designed or executed well, such studies can miss the efficiency goal.

The Danish Medicines Agency has come across several instances of clinical trial sites being placed under “undue pressure” to support...

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