Harmful impact of EU clinical trials directive

Innovative clinical and translational research, instigated and conducted by motivated physician-scientists, has had an important part in the development of modern oncology. For example, adjuvant treatments for breast and colorectal cancer, shown in randomised trials to be effective in preventing recurrence, have been developed and tested through research performed largely by academic clinicians.1^–3 Similarly, such clinicians have been responsible for researching, developing, and introducing sentinel node biopsy and breast conserving surgery, which have reduced morbidity for many hundreds of thousands of women.4 5 Yet investigator initiated academic clinical research is under threat—ironically, from a European Union directive that is aimed at protecting patients and improving research standards.

The official goals of the EU clinical trials directive, implemented in 2004,6 were to improve the protection of patients and the reliability of research reporting and to harmonise and increase the competitiveness of European clinical research. The responsibilities of the research sponsor were increased significantly, and at the outset many investigators were worried that that the labour intensive, bureaucratic, and expensive endeavour of running a clinical trial would become worse.7 In particular, academic researchers …