By Chuck Drucker , Brian O’Dwyer , Patrice Hugo, PhD , Charlie Fix , Caroline Keane , Guy Rachmuth, PhD
Blood self-collection devices are in various states of regulatory approval and their utility varies by the amount of blood they can collect, processing requirements by test, and the creation of tests validated to appropriate regulatory standards and guidelines. The cost of the devices vary, as does the potential cost of patient support and courier fees, but when considering the cost of a site visit or a home visit by a healthcare professional, the cost of self-collection of a blood specimen for certain applications appears favorable. Once devices are perfected and operational processes are solidified, self-collection devices should have a bright future in providing utility for decreasing patient burden in clinical trials and supporting decentralized trial designs.
This article focuses on devices that can potentially enable patients to collect their own blood in their homes for clinical trials. Through technological innovation there are several devices under development for potential self-collection of dried blood spot and liquid blood samples.