The EU Regulations for Clinical Trials-Everything you Need to Know

European Union is made up of 27 countries sharing an economic and quasi-political eco-system. The EU allows for free trade between its members, usually governed by accompanying European legislation. Many legislations govern clinical trials within the jurisdiction of the EU. Part of these measures, such as trial registration, ethics, information management, and patient confidentiality, intends to increase competition with other world regions in the clinical trials sector (EU, 2020).

Currently, there is a lot of legislative effort by the EU to replace conventional clinical trial directives with progressive ones, albeit in stages slated for 2022. This article examines the overarching dispositions encountered by the entity while transitioning through the changes and the implications on clinical trials and need for diversification within them. 

Clinical Trials Directive 2001/20/EC

The Clinical Trials Directive 2001/20/EC came into effect between 2003 and 2004, it is considered recent legislation. The directive sought to standardize the conduction of interventional clinical trials in the EU and ensure equality in safeguarding public health. The directive encompassed crucial elements, including data collection, investigative materials, quality control, ethical guidelines, and the safety of subjects. It consolidated the ethical guidelines on trials involving incapacitated individuals and paediatric issues. Also, the directive guided safety rules regarding the collection and verification of adverse events on trial subjects. The legislation also standardized the registration of the trials in the Union’s clinical database and quality control requirements such as equipment and materials compliant with the region’s manufacturing standards of medicinal products. This is particularly important for cancer patients, since clinical trials are changing outcomes for them.

New Clinical Trials regulations.

The EU parliament approved Regulation EU No 536/2014 on 16^th June 2014. The legislation sought to replace the 2001/20/EC and improve the existing trial processes. However, it is yet to become operational even after its successful passage. The breadth of the regulation is vast and covers the implementation of scaled-up multi-country clinical trials. Unlike its predecessor, it has introduced new trial registration processes and adverse events reporting. A key advantage of the new regulation is a unified IT portal and a clinical trial information system. The web-based platform facilitates trial applications to EMA, communication between governments, and notifications of the involved parties. The framework has embedded tools to grant citizens access to the ongoing trials. The clinical trial regulation provides a legal basis to start, suspend, or terminate a trial. Sponsors often choose to work with a regulatory affairs CRO who can help them navigate the clinical trial regulations in specific geographies. Dokumeds is a clinical research organization with extensive experience in trial regulations in Europe and beyond.

Implications of the New EU Regulations

The new regulations seek to significantly cut down administrative costs previously associated with trial planning while maintaining the safety standards. The single point and approval system will facilitate registration and approval. Unlike the previous frameworks, the central, accessible portal would foster transparency and trust among all stakeholders, including the public. The ease of access to real-time trial information via the portal would enhance transparency and mutual trust among the stakeholders in clinical trials. Besides, it will facilitate partnerships between the public and private sectors.

Data Protection

While the new EU regulations focus on increased transparency, the region prioritizes patients’ privacy. Clinical trials will prioritize General Data Protection Regulation regulations (GDPR), especially when sharing information across sites. The GDPR provides extra coverage and protection to protected data, including personally identifiable and medical information. These measures seek to protect against data breaches, provision of consent before information sharing, and the right to revoke consent.