Clinical Research in Europe: putting quality and patient safety first. Recommendations by the Coalition for Reducing Bureaucracy in Clinical Trials

Accumulating administrative burdens put at risk the quality of clinical trials and the safety of patients. Investigators are overwhelmed by legal, regulatory and sponsor requirements to the extent that they struggle to focus on what really matters: the safety, efficacy, and effectiveness of a treatment. Patients are confronted with informed consent forms and procedures that often
are hard to understand, and that tend to be compliance rather than patient centric. 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. With the needs of investigators and patients as starting point, whilst taking into account stakeholders’ views and
interests, the Coalition for Reducing Bureaucracy in Clinical Trials developed a first set of recommendations in 2021. Encouraging responses to these recommendations from many in the clinical trials ecosystem, combined with the early lessons from the implementation of the EU’s Clinical Trials Regulation
(in effect since January 2022) 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 this 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.