Reducing Bureaucracy in Clinical Research: A Call for Action

he increasing administrative burden associated with conducting clinical trials is a threat to patient safety, independent academic clinical research, and access to affordable innovation. While the Clinical Trials Regulation 1 — adopted by the European Parliament in 2014 to replace the Clinical Trials Directive 2 (from 2001) and fi nally expected to become applicable in the course of 2020 — will go some way in addressing bureaucracy overload, more action is needed. This article discusses the issues resulting from the exponential growth of regulatory and administrative requirements for the conduct of clinical studies and the impact this is having on researchers and patients. It also describes how the European Hematology