The experiences of pharmaceutical companies, study doctors and delivery couriers with delivering trial medication directly to participants in Europe

Acknowledgement & Disclaimer 

This article is not an original, it has been translated by the Trials@Home Layman Translation Team for purpose of a better understanding by a general audience. The team consists of a diverse group of Trials@Home consortium members and the members of the Trials@Home Patient Expert Panel. 

Original paper – Direct-to-Participant Investigational Medicinal Product Supply in Clinical Trials in Europe – Exploring the Experiences of Sponsors, Site Staff, and Couriers

First published: 12 July 2023, British Journal of Clinical Pharmacology

Original authors: Amos J. de Jong, Yared Santa-Ana-Tellez, Mira G. P. Zuidgeest, Renske J. Grupstra, Fatemeh Jami, Anthonius de Boer, Helga Gardarsdottir, on behalf of the Trials@Home Consortium

What is this article about?

Direct delivery of the medication being tested (the trial medication) means that patients who participate in a clinical study get their study medication directly to their homes. Participants don’t need to go to a clinic or hospital to receive the medication. It is necessary to better understand how this delivery should be done. There is no one set of rules on this in Europe. This article is about the pros and cons of delivering trial medication directly to participants, what is difficult, and what could make it easier.

The term “direct trial medication delivery to participants” will be abbreviated as “DtP” throughout the rest of the article. This stands for “direct-to-participant”.