Harmful impact of EU clinical trials directive: Trial of alerting drug in fibromyalgia has had to be abandoned...

doi:10.1136/bmj.332.7542.666

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

Letter

Harmful impact of EU clinical trials directive

Trial of alerting drug in fibromyalgia has had to be abandoned...

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

EDITOR—Hemminki and Kellokumpu-Lehtinen show the impactof the EU Clinical Trials Directive and the resulting additionalcost and bureaucratic delays on cancer drug research.¹ It hasbecome almost impossible for academic researchers to initiateand conduct pharmaceutical trials without the involvement ofa pharmaceutical company, particularly in areas that do notattract much funding or involve a drug that is close to theend of or outwith patent protection.

We recently abandoned attempts to conduct a trial of an alertingdrug in patients with fibromyalgia. The Trials Directorate ofthe Medicines and Healthcare products Regulatory Agency (MHRA)was as helpful as possible within the limits of the regulations,but the cumulative burden of regulatory requirements and delays,both locally and nationally, resulted in the modest grant fromthe pharmaceutical company being almost exhausted before wecould even begin to contemplate the recruitment of a singlepatient.

We endorse . . . [Full text of this article]

Christopher D Hanning, consultant in sleep medicine, Patricia Rentowl, research assistant

Leicester General Hospital, Leicester LE5 4PW chris.hanning@uhl-tr.nhs.uk

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Harmful impact of EU clinical trials directive: Akseli Hemminki and Pirkko-Liisa Kellokumpu-Lehtinen
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