Developments in European Clinical Trial Agreements

Lawyers Tim Worden

In their article associate Tim Worden and partner Benjamin Grzimek examine recent developments in clinical trials agreements in three major European jurisdictions (the UK, France and Germany).

The UK has two model clinical trial agreements, one for use by a sponsor and a trial site, the other for use where a contract research organisation is also involved.  The use of the agreements in unamended form is strongly endorsed by the UK Government, although it is not compulsory.

There is no universal standard clinical trial agreement in Germany.  Recent changes in German employee inventions law have necessitated a review of the structure and contents of clinical trial agreements used in Germany.

Although there is a standard form clinical trials agreement available for use in France, it is not endorsed by the French Government and its use is not compulsory.  From a sponsor's perspective, the standard agreement does not deal adequately with the ownership of intellectual property arising from the trial, or publication rights.

This article was published in the November edition of International Clinical Trials. For more information, please click here