EHA-led Coalition for Reducing Bureaucracy in Clinical Trials publishes new recommendations
The Coalition for Reducing Bureaucracy in Clinical Trials (RBinCT) has published its 2025 Recommendations, offering concrete solutions to improve the quality, efficiency, and patient-centricity of clinical research in Europe.
Founded and led by EHA, the Coalition brings together medical societies and patient advocates committed to reducing unnecessary administrative burdens in clinical trials.
Stating the problem
Clinical trials are increasingly weighed down by legal, regulatory, and sponsor-driven requirements. Investigators struggle to focus on treatment safety and efficacy due to excessive paperwork.
Patients face informed consent procedures that are often difficult to understand and prioritize compliance over clarity.
Since 2020, the Coalition has urged regulators, sponsors, ethics committees, and policymakers to make trials more efficient and patient-centered.
Introducing the 2025 Recommendations
Building on its 2021 Recommendations and early lessons from the EU Clinical Trials Regulation (CTR), the Coalition now presents a more comprehensive set of recommendations.
Structured into three sections—Regulatory, Safety Reporting, and Informed Consent—the 2025 Recommendations aim to deliver short- and medium-term improvements that are practical and feasible.
Regulatory harmonization across the EU
Fragmented regulatory frameworks across Member States discourage sponsors from initiating trials, especially in smaller countries. Harmonization is urgently needed to expand patient access.
The Coalition supports broader adoption of the Reporting Member State-led assessment introduced by the CTR, and calls for EU standardized templates.
We also propose proportional regulatory requirements based on trial risk levels.
Streamlining safety reporting
Safety reporting procedures are a major source of inefficiency and investigator burnout. Duplication across platforms and unclear sponsor protocols obscure critical safety signals.
The Coalition recommends centralizing safety reporting, reducing redundant submissions, and aligning sponsor practices with CTR principles. These changes would allow investigators to focus more on research and patient care.
Patient-centered informed consent
Informed Consent Forms (ICFs) are often long and filled with technical jargon, discouraging participation and undermining equity.
The Coalition recommends moving legal language to appendices and presenting essential information in plain, accessible language. Experts within and consulted by the Coalition developed a patient-friendly ICF template incorporating thorough patient feedback.
A shared responsibility
The 2025 Recommendations do not aim to eliminate all bureaucracy. Instead, they target rules and procedures that fail to enhance trial quality or patient safety.
Their combined implementation would ease the burden on investigators, improve trial efficiency, and make Europe a more attractive hub for high-quality clinical research.
The Coalition calls on all stakeholders—regulators, sponsors, Ethics Committees, and policymakers—to commit to reducing bureaucracy and placing patient needs at the heart of clinical trials.