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.