With Direct-to-patient (DTP) protocols on the rise due to COVID, many sponsors are having to reconsider their IMP returns and destruction strategy.
Since patients will have clinical materials in their home, how can they be returned and reconciled while still maintaining patient privacy? What are the financial implications?
Returns and destructions make up the final milestone of a clinical trial prior to closing it out. When a trial begins, it’s natural to focus on meeting that first patient-in date, and setting up the supply chain as needed.
In this audio recording Gavin Morgan, PCI’s Sr. Global Logistics Manager, discusses IMP returns and destruction and how to handle it including: what level of reconciliation will be needed; who should do the reconciliation, and should clinical materials be exported for returns and destruction.