Activities & Operations

Home shipment and collection

Direct-to-participant (DtP) shipment of investigational medicinal products (IMPs) and study materials, combined with remote biological sample collection, can reduce participant burden and improve accessibility in DCTs. However, these processes introduce operational complexity, including balancing the number of shipments against assembling comprehensive kits, and managing challenges at initiation (IoT) and end-of-trial (EoT) stages. Poorly designed logistics can lead to participant frustration, increased dropout, and data gaps.

Recommendations

Minimise participant burden by reducing the number of separate shipments while avoiding excessive storage requirements at home. Consider assembling multi-component kits for early visits but avoid sending all materials upfront if they will not be used for weeks or months. RADIAL showed that participants often misplaced or discarded unused kits, leading to unplanned resupplies. A phased approach, as in, sending critical materials initially and aligning subsequent shipments with protocol milestones, proved more effective.

Initial and final trial stages require special attention. At IoT, ensure timely delivery of all essential materials for screening and randomisation without overwhelming participants. At EoT, define clear processes for returning unused IMP, devices, and biological samples. RADIAL highlighted that unclear responsibilities for importer/exporter roles and lack of dry runs created delays and contractual challenges. Early planning, including customs and vendor agreements, mitigates these risks.

Implement overage strategies for IMP to prevent treatment interruptions due to shipment delays or temperature excursions. Provide clear instructions and support for sample return and consider courier pick-up or home nurse visits when drop-off points are unreliable. RADIAL demonstrated that direct-from-participant collection, though costly, improved success rates and reduced participant burden.

How Trials@Home reached these recommendations

We analysed operational data from the RADIAL proof-of-concept trial, which compared conventional, hybrid, and fully decentralized arms across six European countries. We reviewed shipment records, participant feedback, and vendor performance, identifying logistical bottlenecks and mitigation strategies. These insights informed practical recommendations to balance efficiency, compliance, and participant experience in future DCTs.

Further reading

Publications

Direct-to-Participant Investigational Medicinal Product Supply in Europe – Experiences from Sponsors, Site Study Staff, and Couriers.

de Jong, et al
British Journal of Clinical Pharmacology
2023
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Read the layman version

The Supply of Investigational Medicinal Product and Management of Study Materials for Decentralized Participants—Insights from the Trials@Home RADIAL Proof-of-Concept Trial.

Heath, et al
Clinical Pharmacology & Therapeutics
2025
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