TY - JOUR T1 - Reducing bureaucracy in clinical trials, now is the time! JF - RMD Open JO - RMD Open DO - 10.1136/rmdopen-2022-002202 VL - 8 IS - 1 SP - e002202 AU - Loreto Carmona Y1 - 2022/02/01 UR - http://rmdopen.bmj.com/content/8/1/e002202.abstract N2 - Over the last few years, clinical trials have become increasingly difficult and expensive to conduct, due in great measure to the disproportionate volume of bureaucratic demands involved. Direct consequences of the rising costs and complexity are the stagnation of clinical research in Europe, fewer academic clinical trials and limited accessibility to innovative treatments.1–3 Crucially, excessive administrative demands limit the time that clinical researchers can dedicate to their patients, with potential negative consequences for the quality of studies and patient safety.The Biomedical Alliance in Europe (BioMed Alliance) is a non-profit organisation representing 36 European research and medical societies, including the European Alliance of Associations of Rheumatology (EULAR), with the goal of improving the health and well-being of all European citizens by promoting the interests of researchers and healthcare professionals across all medical disciplines (https://www.biomedeurope.org/). BioMed Alliance, thus, provides a platform to speak with a unified voice and interact with EU policymakers on key topics in the European healthcare field, and to ensure that the European Research Area is supported with sustainable research policies, among other aims.Together with patient advocates, the BioMed Alliance is calling for urgent actions to diminish bureaucratic burdens and move towards more patient-centred, risk-based, pragmatic, efficient and cheaper trials. In particular, solutions are needed for the following issues:Conservative definitions of Suspected Unexpected Serious Adverse Reactions (SUARs) … ER -