Decentralized Clinical Trials: the "Recommendation Paper" of the European Commission, EMA and the HMA network

Di Nicolò Rossi - Legal Manager

Among the incalculable costs, both in terms of human lives and from an economic point of view, the COVID-19 pandemic severely slowed many of the clinical trials underway throughout the emergency. To deal with the situation and to allow patients to continue receiving care, new trial models have emerged during the pandemic that enable the continuation of remote trials, favouring virtual interactions between doctors and their patients.

In this perspective, so-called "decentralized clinical trials" (DCTs) play a key role, which in the future, we are sure, will go on to become even more popular due to the peculiar flexibility and cost-effectiveness that distinguishes them from "traditional" clinical trials.

DCTs are characterized by less dependence on sites or data collectors, making extensive use of technological tools (such as smartphones, PCs, tablets, wearables, etc.) such as to allow home visits and study drug delivery directly to the patient's home.

As mentioned earlier, the emergency has rapidly increased (canonical) clinical trials with decentralized elements that incorporate traditional design and decentralization of patient interaction. The increasing use of this type of trial recently led the European Commission, together with the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) network, to publish the "Recommendation Paper on Decentralised Elements in Clinical Trials" late last December. 

While this recommendation is not a binding act, it can certainly be useful in discerning a harmonized perspective on the use of decentralized elements in clinical trials in the EU by the "European Medicines Regulatory Network," and is intended to facilitate the conduct of decentralized clinical trials, safeguarding the rights and well-being of participants, as well as the robustness and reliability of the data collected.

PRINEOS provides specific support for conducting decentralized studies and is available to provide more information on this topic.