PUTTING PATIENTS FIRST IN CLINICAL RESEARCH | New EU Recommendations to Reduce Trials Bureaucracy

As Prof. Martin Dreyling, Chair of the Coalition for Reducing Bureaucracy, explains: “The current safety requirements for investigators are disproportionately burdensome, to the point that they may obscure relevant safety signals instead of effectively ensuring participant safety.” Patients are also directly affected, as they are often confronted with complex and lengthy informed consent forms that can make trial participation more difficult.

To address these challenges, the Thalassaemia International Federation (TIF) joined the Coalition for Reducing Bureaucracy in Clinical Trials, launched in 2020 by the European Hematology Association (EHA) in collaboration with the Biomed Alliance. This cross-disciplinary initiative brings together medical societies and patient advocates who first delivered a joint statement, followed by an initial set of recommendations in 2021.

The Coalition has now released a new set of recommendations that build on the 2021 proposals, incorporate stakeholder feedback, and reflect early lessons from implementation of the EU Clinical Trials Regulation. The 2025 Coalition recommendations focus on creating a more harmonized EU regulatory framework, streamlining and rationalizing safety reporting, and ensuring that informed consent procedures are more inclusive and patient-centered.

Together, the proposed measures aim to reduce unnecessary bureaucracy, allowing researchers to focus on delivering innovative treatments to patients while strengthening safety across Europe.

View the Recommendations HERE.