In brief

On 19 December 2022, the Recommendation Paper on Decentralized Elements in Clinical Trials was published on the website of the European Medicines Agency (EMA), with the aim to facilitate the conduct of decentralized clinical trials in the EU, while safeguarding the rights and well-being of participants and the robustness and reliability of the data collected.

Key takeaways

Decentralized Clinical Trials (DCTs) are characterized by the fact that some of the activities pertaining to the conduct of the clinical trial are “shifted” from the trial site to the patient’s home (“decentralization”), including, by way of example, the collection of informed consent electronically, medical visits, the administration of the medicinal product or the use of the medical device directly at the patient’s home.

In particular, the Paper provides recommendations on the following aspects concerning the conduct of the clinical trial with regard to the specific context in which the related activities are performed: (i) roles and responsibilities of the sponsor and investigator, (ii) obtaining the informed consent of the patient through validated electronic tools, (iii) delivery of the investigational medicinal product directly to the patient’s home, (iv) possibility of performing procedures under the study protocol at the patient’s home, and (v) data management and monitoring in a decentralized clinical trial context.

The Recommendations underline that the possibility of using decentralized elements in a clinical trial is, however, subject to the authorization of the national authorities of EU Member States involved in the assessment of the clinical trial.