Mapping and analysis of the EU legislation on Remote Decentralised Clinical Trials including legal, regulatory, ethical and stakeholder recommendations for the conduct of the pan-EU pilot (D4.1)

The Innovative Medicines Initiative (IMI) Trials@Home project is a large multinational private-public partnership launched in 2019 to explore the concept of remote decentralised clinical trials (RDCTs). Within this project, work package 4 (i.e., EAGLE) was tasked to map and analyse the regulatory, ethical, good clinical practice (GCP) and legal aspects of the current European Union (EU) environment relevant to RDCTs.

Since clinical trials (CTs) are authorised and supervised at the national level in the EU, relevant national legislation and guidance can impact CT conduct differently throughout Europe. This deliverable aims to map and analyse the pre-COVID-19 legal and ethical framework at the EU and Member State (MS) levels to identify opportunities and challenges and provide recommendations to others on conducting RDCTs. The mapping includes EU and national legislations, including legal, regulatory, ethical and GCP aspects that may be relevant to RDCTs.

Eleven EU MSs were included in the mapping following criteria on the number of registered CTs and geographical location within Europe to ensure a suitable representation. Regulations at the national level for some remote trial activities in few countries were found. This type of regulations or guidance might already exist in standard operating procedures, policies or codes of conduct at the site level. Whilst compulsory to adhere to, these rules are much harder to monitor and enforce and might have high variability between sites and countries. The COVID-19 pandemic forced the clinical research community to re-evaluate how to manage CTs. During this period, Health Authorities have allowed sponsors to use alternative methods to ensure CTs’ continuation. Even though decentralised clinical trial activities have been commonly conducted in some countries included in the EU mapping, the relevant regulations are still evolving. Provisions need to be incorporated in the regulations to ensure participants’ safety and RDCTs’ results robustness.