LAUSR

In the last few years, clinical trials have become more complex to carry out, mainly because of the increasing volume of needed bureaucratic documents. Therefore, the conduction of academic clinical trials is decelerated, with consequent limited access for patients to cutting‐edge therapeutics. Moreover, the considerable bureaucratic workload limits the time that can be dedicated to patients, decreasing the quality of studies. Both scientific societies and patient associations advocate actions to decrease the bureaucratic burden of clinical trials, making them more practical and less expensive. The most relevant issues include: the safety reporting, as usually the description of suspected unexpected serious adverse reactions (SUSARs) need a burdensome requirement of documents; the informed consent, which is usually long and written with jargon‐ridden terms; regulation and guidelines which are often written vaguely, leading to misinterpretation of rules, as, in examples, for general data protection regulation (GDPR) requirements. An advancement toward a leaner regulation has already been given by the Guidance on the Management of Clinical Trials during the COVID‐19 pandemic, released by the European Commission in March 2020. However, more comprehensive actions are needed to prevent the rarefaction of clinical research in Europe, including the revision of International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use guidelines on Good Clinical Practice (GCP), with the aim of reducing bureaucracy burden and make trials safe, more affordable and understandable by patients. The BioMed Alliance, an organisation representing 36 leading biomedical societies in Europe, including the UEG, has gathered a multidisciplinary coalition of medical societies and patient advocates, to release a joint statement ‘Reducing bureaucracy in clinical trials: now is the time!’, calling for urgent measures to reduce the bureaucracy of clinical trials and make them more efficient and patient‐based, and less expensive, and developing practical recommendations, summarised below, concerning: (I) safety reporting; (II) informed consent; (III) regulatory guidelines; (IV) harmonisation of requirements across the EU. HARMONISATION AND SIMPLIFICATION OF ADVERSE EVENTS REPORTING