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

Letter

Harmful impact of EU clinical trials directive

...and so has trial of melatonin in cancer related weight loss...

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

EDITOR—The editorial by Hemminki and Kellokumpu-Lehtinen on the harmful impact of the EU Clinical Trials Directive highlights important issues that need to be addressed before investigator led cancer research becomes a thing of the past.1 The directive was supposed to protect patients by minimising biasing influences on clinical studies. The reality is that it has made it all but impossible to carry out researcher led studies without the financial and logistical backing of the pharmaceutical industry.

We recently successfully negotiated the new and long EU research directive road, through the process of clinical governance, sponsorship, and ethics approval to run a double blind placebo controlled trial of melatonin in cancer related weight loss. Unfortunately, after 18 months our research quest had to be abandoned because the directive decreed that we needed to have an investigational medicinal product licence. This was not stipulated at the start of the process.

. . . [Full text of this article]

Max Watson, research fellow

Belfast City Hospital, Belfast BT9 7AB alimaxuk@yahoo.com


Add to CiteULike CiteULike   Add to Complore Complore   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us   Add to Digg Digg   Add to Reddit Reddit   Add to Technorati Technorati    What's this?

Relevant Article

Harmful impact of EU clinical trials directive
Akseli Hemminki and Pirkko-Liisa Kellokumpu-Lehtinen
BMJ 2006 332: 501-502. [Extract] [Full Text] [PDF]

Access jobs at BMJ Careers
Whats new online at Student BMJ