Coalition for Reducing Bureaucracy in Clinical Trials
Coalition for Reducing Bureaucracy in Clinical Trials
Since 2020 a broad cross-disciplinary coalition of medical societies and patient advocates has been calling on regulators, policymakers, sponsors, Ethics Committees and other stakeholders in making clinical trials less bureaucratic and more efficient and patient-centred.
Encouraging responses to the first set of the Coalition recommendations in 2021, combined with the early lessons from the implementation of the EU’s Clinical Trials Regulation and growing concerns about the EU’s global competitiveness in clinical research, offered additional inspiration for formulating the more elaborate set of ‘Coalition Recommendations’ presented in a recently published guidance document. It is structured in three parts – Regulatory, Safety Reporting, and Informed Consent – with appended clarifications and two simplified, patient-friendly, highly fit-for-purpose Informed Consent Form templates developed by patient advocates in close collaboration with clinicians and ethics experts. The output of the coalition has been discussed on October 6th 2025 in a meeting with the EU commissions DG Sante.
ESOP is an active member and supporter of this coalition.
You can read the full publication here: https://bureaucracyincts.eu/coalition-recommendations-2025
Reported by Mirjam Crul, the Netherlands
Implementation of these recommendations would mean less bureaucratic burden for all healthcare workers involved in the execution of clinical trials. Furthermore, reducing the bureaucratic burden can make Europe more competitive for execution of clinical trials and thereby provide the opportunity for cancer patients to participate in clinical trials