‘Coalition for reducing bureaucracy in clinical trials’ releases its 2025 recommendations to accelerate innovation and improve patient access

This growing administrative burden not only slows innovation but also diverts the attention and time of healthcare professionals (HCPs) away from patient care. With its newly released 2025 Recommendations, the Coalition aims to drive reform in order to make clinical trials more efficient, patient-centered, and accessible across the EU.

Across Europe, investigators report being overwhelmed by increasing legal, regulatory, and sponsor-driven requirements. These obligations have become so extensive that they often prevent researchers from dedicating enough attention to what truly matters: patient safety and high-quality clinical care.

Patients also face significant burdens. Informed consent forms (ICFs) have become longer and more complex, often shaped by compliance needs rather than patient comprehension. As a result, many patients struggle to fully understand trial information, which can discourage participation and undermine trust between doctor and patient.

The Coalition argues that unless these barriers are addressed, Europe risks failing in its ambition to remain a world leader in clinical research and medical innovation.

The Coalition’s 2025 Recommendations propose a series of practical, proportionate reforms that are designed to streamline trial procedures while maintaining high standards of patient safety. These include:

• Making informed consent forms patient-centered by moving legalistic and highly technical information to appendices.
• Reducing excessive and inefficient reporting requirements between investigators and sponsors or CROs.
• Creating standardised EU-wide templates to harmonise documentation and reduce duplication across Member States.
• Introducing a centralised EU safety reporting platform, simplifying the fragmented systems currently used by investigators.
• Ensuring proportionality in regulatory requirements, avoiding a ‘one-size-fits-all’ approach.
• Improving and extending the Reporting Member State (RMS)-led assessment, ensuring more predictable and coordinated trial evaluations.
• Simplifying procedures for academic sponsors, who are disproportionately affected by complex administrative demands.

By reducing bureaucracy, Europe can create an environment where innovation reaches patients more quickly, and clinicians can devote their time to what they do best: providing care, not managing paperwork.

Stakeholders across the research and healthcare sectors are encouraged to engage with the Coalition, explore the full recommendations, and join the movement toward a more efficient and patient-centered clinical trial landscape.

Read the joint statement by medical societies and patient advocates here.