Launch of revised model Clinical Trial
Agreement
30 October 2006
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.
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.