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Regulations and Decentralized Trials in Europe

With recent EU regulatory recommendations made around DCTs, here’s everything you need to know.

The European Union (EU) recently issued new regulatory recommendations for Decentralized Clinical Trials. This will significantly impact clinical research in the region. The recommendations reflect the EU’s efforts to embrace the latest digital technologies. Improving efficiency and effectiveness of clinical trials while maintaining high standards of patient safety and data quality.

Background on the EU Recommendations

Decentralized Clinical Trials (DCTs) use digital technologies to facilitate the conduct of clinical research outside traditional clinical trial sites. These trials can include a variety of remote activities, such as electronic consent, telemedicine visits, and remote monitoring. Decentralized trials offer benefits including increased patient accessibility and convenience, reduced costs, and accelerated recruitment and data collection.

As a result, the European Union (EU) has released regulatory recommendations for decentralized clinical trials. These recommendations are an extension of the existing regulatory framework for clinical research in the region. Additionally, this framework includes the Clinical Trials Regulation 536/2014 and the International Council for Harmonisation (ICH) guidelines for Good Clinical Practice (GCP).

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) worked together with stakeholders from academia, industry, and patient organizations to develop the new recommendations.

What’s New to the European Regulations with Regard to DCTs?

One of the main changes since the last regulatory recommendations for DCTs in the EU is the recognition of the need for flexibility and adaptability. The new recommendations acknowledge that the use of digital technologies can enable more personalized and patient-centric clinical research. But, as a result, also require a risk-based approach to ensure data integrity, privacy, and security. The recommendations also emphasize the importance of involving patients and the public in the design and conduct of DCTs. This is to ensure that their needs and preferences are taken into account.

The new recommendations provide guidance for sponsors, Contract Research Organizations (CROs), and clinical trial sites on how to interpret and apply the regulatory requirements for DCTs. For example, the recommendations clarify the regulatory requirements for electronic informed consent (eConsent). Including the need for a secure and reliable platform, a clear and understandable format, and the ability to provide additional information and support to participants. Another point is to also provide guidance on the use of telemedicine in clinical trials. Including the need for appropriate training and certification of healthcare professionals, and the need for robust data privacy and security measures.

TL:DR? Here’s a Summary of How The EU Recommendations Will Impact the Region

Overall, the new EU regulatory recommendations for DCTs are expected to facilitate the adoption of digital technologies in clinical research. As I have noted, will improve patient access and engagement. And reduce the burden on traditional clinical trial sites. However, their implementation may also require significant changes in the way clinical trials are designed, conducted, and monitored. Sponsors, CROs, and sites will need to invest in appropriate infrastructure, technology, and training to ensure that decentralized trials meet regulatory and ethical standards and provide high-quality and reliable data.

The new EU regulatory recommendations for decentralized clinical trials are due to the changing landscape of clinical research and the potential of digital technologies to transform the way trials are conducted. While the recommendations provide valuable guidance and support, their implementation will require a collaborative and adaptive approach from all stakeholders involved in clinical research. Altogether, by embracing the opportunities and challenges of decentralized trials, the EU can further enhance its position as a leader in clinical research and innovation.

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European Medicines Agency. (2021). Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) Pandemic.

European Medicines Agency. (2022). EMA/HMA Joint Big Data Task Force.

International Council for Harmonisation. (2016). Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2).

European Medicines Agency. (2021). Clinical Trials Information System (CTIS).

European Medicines Agency. (2021). Draft Regulatory Guidance on Decentralized Clinical Trials.