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

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.

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 or other address. Other models have involved delivering IMPs from local and central pharmacies.

These are the finding of a study conducted by researchers on behalf of Europe’s Trials@Home Consortium, which examined how direct-to-participant (DtP) IMP supply has been used in clinical trials in Europe.

As noted by the study authors, DtP supply of IMPs can enable the decentralization of drug trials – decentralized clinical trials (DCTs) are trials in which activities are conducted in participants’ homes and local settings, rather than at investigative sites, potentially improving accessibility and reducing the burden on participants.