BMJ  2006;332:501-502 (4 March), doi:10.1136/bmj.332.7540.501

Editorial

Harmful impact of EU clinical trials directive

Academic clinical research in cancer seems to have no future in Europe

The first 150 words of the full text of this article appear below.

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 . . . [Full text of this article]

Cancer Gene Therapy Group, University of Helsinki and Department of Oncology, Helsinki University Central Hospital, FIN-00014 Finland
(akseli.hemminki@helsinki.fi)

Tampere University Hospital, Tampere, FIN-33521 Finland
(Pirkko-Liisa.Kellokumpu-Lehtinen@uta.fi)

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Rapid Responses:

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Harmful impact of EU clinical trials directive

Christopher D Hanning, et al.
bmj.com, 3 Mar 2006 [Full text]

Re: Harmful impact of EU clinical trials directive

Max Watson
bmj.com, 5 Mar 2006 [Full text]

Harmful impact of EU clinical trials directive

Christopher D Mitchell
bmj.com, 7 Mar 2006 [Full text]

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