The Coalition for Reducing Bureaucracy in Clinical Trials, which includes a broad range of medical societies and patient organisations, has published an updated set of recommendations which aim to reduce bureaucracy in clinical trials while putting quality and patient safety first.
Accumulating administrative burdens are putting the quality of clinical trials and the safety of patients at risk. Investigators are overwhelmed by legal, regulatory, and sponsor requirements, making it increasingly difficult to focus on what truly matters: the safety, efficacy, and effectiveness of treatments. Meanwhile, patients often face complex informed consent forms and procedures that prioritise compliance over clarity and patient-centredness.
Since 2020, a broad cross-disciplinary coalition of medical societies and patient advocates, including the BioMed Alliance, has been urging regulators, policymakers, sponsors, Ethics Committees, and other stakeholders to make clinical trials less bureaucratic, more efficient and patient-centred. With the needs of investigators and patients as a starting point, and while considering stakeholders’ views and interests, the Coalition for Reducing Bureaucracy in Clinical Trials developed an initial set of recommendations in 2021.
Encouraged by the positive response from across the clinical trial ecosystem, and informed by early experiences with the EU Clinical Trials Regulation (effective since January 2022), the Coalition has now released a more detailed set of ‘Coalition Recommendations’. These also reflect growing concern about the EU’s global competitiveness in clinical research.
The new recommendations are structured into three key areas: Regulatory, Safety Reporting, and Informed Consent. They are accompanied by clarifications and two simplified, patient-friendly informed consent form templates, developed in close collaboration between patient advocates, clinicians, and ethics experts.
Read the full recommendations here: Recommendations by the Coalition for Reducing Bureaucracy in Clinical Trials
