Expert comment: FAST-EU: Accelerating clinical trials to boost Europe’s competitiveness

EU struggles to attract clinical trials

The EU’s appeal as a region for conducting clinical trials has declined, with the share of clinical trials sharply dropping over the past decade – from 22% in 2013 to 12% in 2023 (EFPIA 2024).

Although progress has been made to reverse this trend through the implementation of the EU Clinical Trial Regulation (CTR 536/2014) and the introduction of the Clinical Trials Information System (CTIS), which provides a single portal for clinical trials in the EU, many challenges still remain for companies conducting trials in the region.

National efforts

Alongside these EU-wide initiatives, several member states have introduced national incentives to improve conditions for conducted clinical trials, including but not limited to:

• Faster patient enrolment – an area in which EU still lags significantly behind the US and China
• Increased patient retention – achieved by reducing patient burden through measures such as patient focused protocols and enhanced mechanisms for building trust
• Robust clinical trial infrastructure – a collaborative ecosystem supported by national regulations aligned with the EU-wide regulatory framework
• Decentralised clinical trials – leveraging technological and digital solutions to enable more clinical trials to be conduct outside traditional hospital settings
• Leveraging data for Real World Evidence (RWE) – an area of strength for the Nordic countries, thanks to their comprehensive health registries
  
  

Streamlining multinational trials even further

To accelerate the work even further several Medical Agencies as well as Ethics Committees have committed to test a coordinated fast-track approach for evaluating multinational clinical trials in what has become known as FAST-EU (Facilitating and Accelerating Strategic Trials) which will launch in January 2026.

The goal is to streamline coordination between authorities and ethics committees, enhance predictability for clinical trial sponsors and reinforce confidence in the European regulatory system.

FAST-EU aims to make Europe a more efficient and attractive region for clinical trials, benefiting sponsors, patients, and the broader healthcare system. It will be interesting to follow its development in the coming years.