The Clinical Trials Regulation 536/2014 can be a catalyst for clinical research in the EU if its ambition is matched by a shift in mindset across the research ecosystem. In addition, making Europe a more attractive location for clinical research affords patients the opportunity to access the very latest advances in treatment as early as possible.

EFPIA, representing the research-based pharmaceutical industry in Europe, welcomes the long-awaited application of the Clinical Trials Regulation including the go-live of the Clinical Trials Information System (CTIS). The CTIS is a key element of the new framework for clinical research. It provides a single-entry point for clinical trial application submission, authorisation and supervision in the EU and the European Economic Area (EEA).

The CTIS is the culmination of intensive collaboration between various stakeholders, including EFPIA members and EU regulators. This collaboration has delivered the structure, system and processes needed for application of the Regulation. By working together, Europe’s clinical research stakeholders have streamlined, at a practical level, how clinical trials are approved and regulated.

Throughout this process, our shared goal has been to ensure that the EU remains a competitive place to conduct clinical research. It facilitates European patients having the opportunity to access new clinical trials while ensuring the highest levels of protection to trial participants and safeguarding the integrity of the data generated from the trials.

The Regulation will strengthen oversight and harmonisation across Member States through coordinated safety assessment. This will improve the robustness of safety data on medicines under development.

Building on progress

The welcome advances ushered in by the Regulation must inspire a broader and sustained effort to drive competitiveness in European clinical research. In this fast-moving and highly competitive global environment, there are new advances on the horizon and fresh challenges ahead. How we respond to these together will shape Europe’s future as a clinical research hub and importantly, the availability of clinical trials for patients across Europe.

Clinical trial designs are becoming more innovative, delivering greater efficiencies, and enabling a more diverse patient population to participate in trials. Digitalisation of trials brings new tools for conducting studies that are more inclusive and more convenient for patients. These advances should be embraced.

However, changes can bring new levels of complexity in the management, running and oversight of trials. The implementation of the Clinical Trials Regulation is an opportunity to ensure this does not slow down and over-burden the process for approval, start-up and running of trials. Nor should the new framework hinder the acceptance of evidence generated from those trials.

‘This is the beginning of an exciting new phase for clinical research in Europe,’ said Nathalie Moll, EFPIA Director General. ‘The work is not finished as the system will need to evolve and develop over time. We must ensure that this landmark moment for European clinical research is accompanied by a change in the hearts and minds of those overseeing and conducting clinical trials so Europe can be at the forefront of clinical research and European citizens get the early opportunity to participate in clinical trials.’

EFPIA calls upon all stakeholders to embrace the changes needed and to make the application of the Clinical Trials Regulation a European success story.