By Rich Nelson, Sr. Manager Global Logistics, PCI Pharma Services
In the midst of the COVID-19 pandemic, clinical trial sponsors are having to quickly find alternative methods to keep their trials moving forward as challenges arise such as clinical sites having to close, or patients being unable to travel to the sites for safety reasons.
To keep clinical trials on track, Direct-To-Patient (DTP) shipments have significantly increased since March 2020. As of April 17, 2020, the FDA is allowing DTP shipments to be used as an alternate distribution method without amending the clinical protocol. If you have questions regarding what exactly is allowed, please contact your local IRB or FDA office and have your regulatory group confirm this before proceeding with Direct-To-Patient shipments.
It is important to remember that the term ‘Direct-To-Patient’ can be misleading, as an intermediary stop will always be required for DTP shipments, be it a central pharmacy or a clinical site. Kits can never go directly to patients from a central depot. Therefore, using experienced courier partners is extremely helpful to navigate DTP, especially if a sponsor is switching to the DTP method rapidly.