Coalition for reducing bureaucracy in clinical trials’ releases its 2025 recommendations

Founded in 2020 by leading medical societies and patient advocates, the Coalition for Reducing Bureaucracy in Clinical Trials is a plan to tackle one of the largest issues to clinical research in Europe: excessive and inefficient bureaucracy. Bureaucracy means having too many rules, forms, and steps to get something done. It often involves slow, complicated processes where a lot of time on paperwork.

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

Across Europe, researchers running clinical trials report being overwhelmed by increasing legal, regulatory, and sponsor-driven requirements. These obligations have become so huge that they often prevent researchers from dedicating enough attention to 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 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 inefficient reporting needs between clinical trial researchers and sponsors or CROs. (Contract Research Organisations)
• Creating standard EU-wide template to harmonise documentation and stop duplication across Member States.
• Introducing a central 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 can be 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.