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

Amos J de JongYared Santa-Ana-TellezMira G P ZuidgeestRenske J GrupstraFatemeh JamiAnthonius de Boer Helga Gardarsdottirnull null

Published in: British journal of clinical pharmacology (2023)

Several DtP IMP supply models are implemented in clinical trials conducted in Europe. In this study, three main DtP IMP models were identified, which can be referenced when describing these approaches for regulatory approval.

Keyphrases

clinical trial
phase ii
mental health
transcription factor
open label
phase iii
study protocol