Medical societies and patient advocates across disciplines call for urgent action to make clinical trials less bureaucratic and more patient-centered, efficient and cheaper.
Excessive administrative demands lead to rising costs and complexity, stagnation of clinical research in Europe, fewer academic clinical trials and limited access to innovative treatments. Unnecessary, inefficient, overly complex or ambiguously worded regulations, guidelines, safety reporting requirements and informed consent procedures pose a threat to exactly that which they were designed to protect: the quality of clinical trials and the safety of patients.
That more flexible, risk-based and pragmatic regulation is possible, without compromising either quality or safety, was demonstrated by the guidance issued by European regulators on the management of clinical trials during the Covid-19 pandemic. 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.
At stake is the efficiency and affordability of clinical trials, and with it the quality of future health care and – ultimately and most importantly – patient safety.