Risk Mitigation In Direct-To-Patient Clinical Trials

By Nicole Gray, Director, Strategic Supply Solutions, Catalent

The COVID-19 pandemic has disrupted every part of “normal” day-to-day life, including clinical trials and the traditional way of conducting them. Many clinical sites found themselves acting as a shipping department, trying to make sure all of their patients received their drug safely and on time. CRAs performed remote oversight visits, virtual site tours, and virtual accountability audits. Sponsors quickly began to rethink their Direct-to-Patient (DTP) approach as patients increasingly requested that their study drugs be shipped to their homes.

Use and acceptance of DTP may have grown faster due to the pandemic, but the overall trend toward the decentralized clinical trial (DCT)/DTP model was on the rise pre-2020 and is projected to grow significantly over the next few years. Sponsors that can add flexibility into their protocol designs, standard operating procedures and quality oversight process will be able to effectively benefit from utilizing the DTP model.

A well-planned DTP study can be beneficial to patients and sponsors, but this model can prove to be more complex to get started than the traditional model.

This article reviews how to mitigate risk in DTP studies and how DTP studies mitigate operational risks.