Harmful impact of EU clinical trials directive: ...while paediatric oncology is being scuppered

doi:10.1136/bmj.332.7542.666-b

BMJ 2006;332:666 (18 March), doi:10.1136/bmj.332.7542.666-b

Letter

Harmful impact of EU clinical trials directive

...while paediatric oncology is being scuppered

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

EDITOR—The editorial by Hemminki and Kellokumpu-Lehtinenis a startling summary of the impact of the EU Clinical TrialsDirective and the associated national legislation on the conductof investigator led research.¹ It is remarkable how little responseor debate has emerged since the introduction of this directive:every investigator with whom I have discussed its impact complainsabout increasing bureaucracy and associated costs.

Paediatric cancer, by its nature, involves only small numbersof patients and relies almost exclusively on investigator ledtrials. Over the past few decades, there have been major advancesin the outcomes for children with leukaemia and Wilms' tumour,to choose but two conditions. In the past nearly all childrenin the United Kingdom with such conditions were included ina clinical trial. Now, however, the financial and administrativeburden that has recently been inflicted is beginning to erodethe traditionally high rates of recruitment . . . [Full text of this article]

Christopher D Mitchell, consultant paediatric oncologist

John Radcliffe Hospital, Oxford OX3 9DU chris.mitchell@paediatrics.ox.ac.uk