The Coalition for Reducing Bureaucracy in Clinical Trials (RBinCT), which includes a broad range of medical societies, patient organisations, and BioMed Alliance has published a new article online in Nature Medicine outlining concrete recommendations to simplify and streamline clinical trials in Europe.
The article highlights how complex and fragmented regulatory requirements, disproportionate safety reporting obligations, and lengthy, overly technical informed consent forms place significant strain on investigators and patients without improving patient safety or research quality.
To address these challenges, the Coalition puts forward recommendations in three key areas: improving the EU regulatory framework, streamlining safety reporting, and making informed consent more patient-centred. The recommendations build on lessons learned from the implementation of the EU Clinical Trials Regulation and are grounded in the real-life experiences of investigators and patient advocates.
Read the full recommendations here: Reduce bureaucracy in clinical trials now | Nature Medicine
