White paper: Rapidly Switching to Direct-To-Patient Protocols

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Rapidly Switching to Direct-To-Patient Protocols

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.

This white paper will answer the following questions:

  • How does the courier know where to go?
  • In this COVID-19 situation, how would you handle Direct-to-Patient when the site is closed with no access to trial product?
  • What does the actual delivery look like during this time of COVID-19?
  • Are there any countries where it would be more difficult to implement DTP due to COVID-19?
  • Each state (in the USA) has its own requirements. Can the central pharmacy ship to any location in the US?
  • How does PCI support the DTP process?
  • What if the clinical site doesn’t want materials returned, can we ship the material back to the US or must we use a local depot?
  • When a courier delivers clinical supplies, how long does it take for the temp data to get back to the sponsor?
  • Is the process of DTP in Canada the same as the US?

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