September 25, 2020

Coalition Statement published today

ESICM joins Coalition of European Medical Societies calling for urgent action to reduce bureaucracy in CTs

ESICM has joined forces with the European Hematology Association (EHA) and other medical societies and patient advocates across disciplines in a coalition calling for urgent action to make clinical trials less bureaucratic and more patient-centered, efficient and cheaper.

The joint statement, published earlier today, explains that 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 are designed to protect: the quality of clinical trials and the safety of patients.

More flexible, risk-based and pragmatic regulation is possible, without compromising either quality or safety, and this has been demonstrated in 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.

Read the joint statement by medical societies and patient advocates, here.

 

 

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