EU regulators issue guidance on decentralised trials

The EU has published new recommendations aiming to encourage the use of decentralised clinical trials (DCTs) – and to make sure patients who participate in them have their wellbeing safeguarded.

The recommendations are part of the ACT EU initiative between the European Commission, the European Medicines Agency (EMA), and the Heads of Medicines Agencies (HMA) group – launched earlier this year – and are intended to further develop the EU's role as a centre for clinical research.

In a statement, the regulators note that the aim of DCTs – enabled by digital tools, telemedicine, and more mobile and local healthcare – is to make it easier for patients to participate in clinical trials by reducing the need to travel to central trial sites.

This approach, which relies on home health visits, remote monitoring and diagnostics, direct-to-patient shipment of study drugs, and electronic informed consent, has the potential to make clinical trials available to a wider demographic of participants and reduce drop-out rates, they add.

The document (PDF) acknowledges that DCT design elements are already being used in clinical research, having gained momentum during the COVID-19 pandemic. A recent Medidata study found, for example, that 43% of trials deployed at least one DCT technology before the pandemic, but that has now risen to 55% and is predicted to climb further to 66% in the next five years.

There is, however, still a need for guidance in areas like sponsor/investigator responsibility, electronic informed consent, delivery of the experimental medical product, and trial-related procedures at home, as well as data management and trial monitoring.

A key consideration in the context of oversight responsibility is that, with patients visiting an investigation site less frequently, alternate methods of monitoring their health status and data need to be used.

Trial participants, investigators, and service providers involved in the trial should receive training on how to use the digital tools employed in the trial, to ensure proper data collection, review, and transmission, says the document.

There is also advice on the informed consent process, such as the initial interview, digital information leaflets, and methods to get signatures, as well as issues that should be considered if investigational drugs are being delivered to patients at their homes.

There is also an overview of national provisions for specific DCT elements to be used in clinical trials.

"These recommendations under ACT EU are a first and important step towards clarifying the use of decentralised clinical trials in the EU/EEA by the European medicines regulatory network," say the partners. "They are expected to evolve as knowledge increases and experience is gained."

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