Medical societies and patient advocates across disciplines call for urgent action to make clinical trials less bureaucratic and more patient-centered, efficient and cheaper.
To achieve this, stakeholders cooperate in a new coalition addressing excessive bureaucracy in clinical trials and the BioMed Alliance plays an active role.
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.
The Coalition to reduce bureaucracy in Clinical trials is continuing its work through working groups which aim to formulate proposed solutions and recommendations for each of the main issues identified in the statement.