A model clinical trials agreement

doi:10.1136/bmj.39030.418229.BE

BMJ 2006;333:1083-1084 (25 November), doi:10.1136/bmj.39030.418229.BE (published 17 November 2006)

Editorials

A model clinical trials agreement

The Department of Health's new model agreement raises questionsabout the NHS's relation with industry

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

Good clinical research is hard to do at thebest of times, and there is a growing perception that the regulatoryenvironment is making it increasingly difficult to plan andcarry out clinical trials within a realistic time frame. A recenteditorial in the BMJ claimed that the 2004 European Union clinicaltrials directive has hindered this process.¹ Anyone who hastried to carry out a clinical trial, particularly a multicentreone, knows only too well the frustrations of seemingly endlessnegotiations during the review process. While research may bea moral duty^w1 in our search for better ways of caring, we mustalways be on guard against using patients and volunteers asa means to an end, as the TGN1412 tragedy recently emphasised.²

On 30 October 2006, the Department of Healthannounced that a model clinical trials agreement had been finalised—aremarkable achievement that should be welcomed by all . . . [Full text of this article]

Michael D E Goodyear, assistant professor

¹ Division of Medical Oncology, Department of Medicine, Dalhousie University, Halifax, NS, Canada B3H 2Y9

MGoodyear@dal.ca