A revised model Clinical Trial Agreement (mCTA) for industry sponsored clinical trials has been launched today. The revised mCTA has been developed and agreed by the Association of the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIA), the NHS and the Department of Health and endorsed by the Council of Heads of Medical Schools. The Agreement is designed to speed up the contracting process for industry sponsored trials in patients in the NHS, allowing approved trials to begin more quickly. It will also save money for the NHS and companies by removing the need for legal review of trial specific agreements.

UKCRC Partners strongly advocate the routine use of the Agreement without modification – (see UKCRC Partners' statement)

The mCTA was originally developed in 2003 by the Department of Health and the ABPI for use in industry sponsored contract research in patients in NHS hospitals. The revised agreement now takes into account evolving legislation and research governance requirements; changes that have taken place in the NHS, particularly the creation of Foundation Trusts; NHS and industry experience of using the first version of the Agreement; and industry undertakings to register trials and publish research findings.

Versions of the mCTA have been developed for use in England, Northern Ireland, Scotland and Wales to ensure compliance with the law and to reflect institutional arrangements across the UK.

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