EU Picks Up The Pace On Home Delivery Of Study Drugs
As drug companies get “really organized” about incorporating patient-centric elements in their clinical trials, a senior executive at a global courier company says the time is ripe for the EU to produce harmonized guidance on easing a clinical trial participant’s access to the study drug.
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Researchers working on behalf of the EU’s public-private Trials@Home project offer insight into practices for direct-to-participant supply of investigational medicinal products in clinical trials.
The EU recommendation paper on decentralized clinical trials (DCTs) marked an important “first step” on the direction the European regulatory network wants to take with DCTs. Member states are now focused on reviewing and tracking DCTs to gain experience before considering the need for any updates to the recommendation paper.
This second segment of a two-part Pink Sheet article on decentralized clinical trials looks at ensuring that staff at study sites are on onboard to support fast-paced change in this field, how regulatory guidance can help tackle hesitancy, and the need to transparently track such studies.