Facilitating Decentralised Clinical Trials in the EU
Recently, recommendations have been published by the European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) with the aim to facilitate the conduct of decentralized clinical trials (DCTs). This was an outcome of their joint initiative called Accelerate Clinical Trials in the European Union (ACT EU).
These recommendations were put together with experts from regulatory bodies responsible for the authorization of clinical trials, members of ethics committees, good clinical practice inspectors, methodology experts and representatives of patient organisations.
Clinical trials are usually conducted at specific clinical trial sites, where patients have to travel to. By conducting DCTs it would be easier for patients to participate in clinical trials as it reduces the need to travel to central trial sites. As a result, clinical trials can be made available to a wider demographic of participants and reduce drop-out rates.
The advancement of digital tools, telemedicine and more mobile and local healthcare would enable such decentralization, including aspects such as:
- home health visits
- remote monitoring and diagnostics
- direct-to-patient shipment of study drugs
- electronic informed consent
The recommendations also include an overview of national provisions for specific DCT elements to be used in clinical trials.
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