BMJ  2004;329:1044 (30 October), doi:10.1136/bmj.329.7473.1044

Letter

Compulsory registration of clinical trials

Maybe European research should be protected

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

EDITOR—The merits of transparency of clinical research from the ethics point of view are not to be disputed. The request of the International Committee of Medical Editors for a publicly accessible registry seems exaggerated in its present form, and we agree with Abbasi's points.^{1 2}

A further, more serious, development is the fact that, in practice, a monopoly is created—namely, the unavoidable use of the US based registry www.clinicaltrials.gov. We emphasise this point because a monopoly already exists with direct and substantial impact on European clinical trials.

The standardised international terminology that is required by the now implemented European Directive 2001/20/EC is clearly the terminology of MedDRA (Medical Dictionary for Regulatory Activities). It can be obtained only from a single source and must be purchased on the basis of an annual subscription.

The maintenance and support service organisation for MedDRA is Northrop Grumman, one of the Pentagon's prime . . . [Full text of this article]

ernst.singer@meduniwien.ac.at, Ethics Committee of the Medical University of Vienna, Borschkegasse 8b, A-1090 Vienna, Austria

Ethics Committee of the Medical University of Vienna, Borschkegasse 8b, A-1090 Vienna, Austria

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Compulsory registration of clinical trials

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