BMJ  2004;328:1036 (1 May), doi:10.1136/bmj.328.7447.1036

News

Squeezing academic research into a commercial straitjacket

Susan Mayor

London

New EU regulations for clinical trials come into effect this week. Susan Mayor talks to academics about the danger they pose to research

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

A new European directive on clinical trials that takes effect this week may seriously damage academic medical research by applying a "one size fits all" approach to the organisation of clinical trials that is more suited to trials designed for the registration of new drugs by pharmaceutical companies.

The aim of the European Union Clinical Trials Directive (2001/20/EC) was to harmonise the approval and monitoring of clinical research in different countries in Europe and to set pan-European standards of protection for all participants in clinical trials. It requires that all trials have a single sponsor, who carries full responsibility and liability, including covering the costs of all drugs or devices used in a study. This concept is familiar to commercial clinical research, where a pharmaceutical company is generally the sole sponsor of a trial. However, publicly funded research studies have previously generally operated as collaborations in which partners oversee different . . . [Full text of this article]

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Rapid Responses:

Read all Rapid Responses

You can have more than one sponsor
Kiain J.D. Balloch
bmj.com, 30 Apr 2004 [Full text]
The EU Directive may prevent many useful clinical trials of modest proportions with minimal risk
Trevor LP Watts
bmj.com, 30 Apr 2004 [Full text]
What is it about academics?
Malcolm VandenBurg
bmj.com, 3 May 2004 [Full text]
EU directive is damaging.
Sue M Richards
bmj.com, 5 May 2004 [Full text]
Do investigators know about the EU directive?
Moira MB Mungall, et al.
bmj.com, 12 May 2004 [Full text]
NOT ALL BAD NEWS
Janet H Darbyshire
bmj.com, 5 Jun 2004 [Full text]
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