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Decentralized Trials: EU Study Explores Different Models For Directly Shipping Drugs To Patients

 
• By Vibha Sharma

Researchers working on behalf of the EU’s public-private Trials@Home project offer insight into practices for direct-to-participant supply of investigational medicinal products in clinical trials.

close up of asian female patient wear mask covering blanket unpacked medicine from pharmacy medication package box delivery service at home
Shipping Drugs Directly To Participants Can Reduce The Need For Traveling To Trial Sites • Source: Shutterstock

The EU lacks harmonized regulatory requirements on how investigational medicinal products (IMPs) can be shipped directly to study participants instead of being dispensed at clinical trial sites, but this has not deterred trial sponsors from experimenting with different approaches on this front.

The most commonly deployed model is one with the least regulatory barriers in which the IMP is shipped from the investigative site or the site's pharmacy to the participant's home...

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