Cross-disciplinary appeal for less bureaucracy,
improved patient safety,
and better trials

The Coalition for Reducing Bureaucracy in Clinical Trials

In September 2020 a broad cross-disciplinary coalition of medical societies and patient advocates issued the joint statement ‘Reducing bureaucracy in clinical trials: now is the time!’. The statement calls for urgent action to make clinical trials less bureaucratic and more patient-centred, efficient and cheaper. At stake are the quality of clinical trials, access to innovative treatments and, crucially, patient safety. The Coalition calls on regulators, policymakers, sponsors, ethics committees and other stakeholders to collaborate to ensure that regulatory guidelines, safety reporting requirements and informed consent procedures do not harm what they are meant to protect: clinical trial quality and patient safety.

Since then, the Coalition has developed a series of concrete and consensus-based recommendations for reducing administrative burdens in clinical trials, clustered around four main themes: Safety reporting, informed consent, regulatory guidelines, and harmonisation of requirements across the EU.

These recommendations reflect, first and foremost, the views and needs of investigators and patients, but have taken in as much as possible the views of regulators, sponsors, ethics committees and other stakeholders. Their willingness to engage in dialogue and join the search for realistic, pragmatic and broadly-supported solutions has been invaluable in enhancing the quality and relevance of these recommendations.

The Coalition's achievements

Since its creation in 2020, the Coalition for Reducing Bureaucracy in Clinical Trials has:

  • Increased awareness of administrative burdens and the risk they pose to the quality of clinical trials and the safety of patients
  • Served as the common voice of academic investigators and patient advocates in discussions on the emerging EU clinical trials governance framework
  • Developed Coalition Recommendations for Reducing Bureaucracy in Clinical Trials (Nov. 2021)
  • Engaged in and influenced the drafting of implementation guidance on the EU Clinical Trials Regulation
  • Engaged in and influenced the revision of ICH guidelines, particularly ICH E6(R3)
  • Contributed to the development of guidance on randomized controlled trials by the Good Clinical Trials Collaborative
  • Ensured that reducing administrative burdens are firmly on the agenda of the ACT EU initiative
  • Ensured active involvement of Coalition members in ACT EU
  • Successfully lobbied for inclusion of the ethics community in the EU regulatory framework for clinical trials
  • Established ongoing dialogues with policymakers, regulators, sponsors, CROs, ethics committees and other stakeholders
  • Exchanged information with interested organizations in the UK, US, Canada and other countries outside the EU


For more on the Coalition’s work between 2020 and 2023, read the full article on its achievements.

For information on the current activities of the Coalition, please contact the coordination team at bureaucracyinCTs@ehaweb.org.