ERS has joined with medical societies and patient advocates across disciplines to call for urgent action to make clinical trials less bureaucratic, more patient-centred and cheaper.
The statement points to the excessive administrative demands of clinical trials which lead to rising costs and complexity, stagnation of clinical research in Europe, fewer academic clinical trials and limited access to innovative treatments, as well as unnecessary, inefficient, overly complex or ambiguously worded regulations, guidelines, safety reporting requirements and informed consent procedures which pose a threat to the quality of clinical trials and the safety of patients.
The statement argues that more flexible, risk-based and pragmatic regulation, without compromising either quality or safety is possible and was demonstrated by the guidance issued by European regulators on the management of clinical trials during the COVID-19 pandemic, and that a substantial and structural reduction of bureaucracy in clinical trials must be the shared goal of clinical researchers, patient advocates, policymakers and regulators at EU and national levels, ethics committees and the pharmaceutical industry.