Direct-to-Participant Supply of Investigational Medicinal Products

This article is a research study that investigates the current practices of direct-to-participant (DtP) supply of investigational medicinal products (IMPs) in clinical trials in Europe. The study aims to outline how DtP IMP supply has been utilized in Europe, identifying advantages and disadvantages as well as barriers and facilitators related to its implementation. The research was conducted through semi-structured interviews with representatives from sponsor companies, courier services, and site study staff involved in the dispensing and delivery of IMPs. Data were collected and analyzed using thematic analysis during interviews held from May to November 2021. The findings indicate that various models of DtP IMP supply are in use, including shipment from investigative sites, central pharmacies, and local pharmacies. The study concludes that while the site-to-participant shipment is not hindered by regulatory barriers, challenges such as participant privacy and regulatory oversight were noted, highlighting the need for harmonized regulations regarding DtP supply practices in Europe.