The Association of the British Pharmacy Industry (ABPI) has announced the release of an updated version of the model clinical trial agreement (mCTA) templates for use in industry-sponsored research conducted on NHS/HSC patients in the UK.
Summary of changes to mCTA template
The main changes from the previous version are as follows:
– A single mCTA template replaces the previously separate regional templates for England, Scotland, Northern Ireland and Wales.
– The new template includes changes to reflect current practices and regulations in the areas of data protection, freedom of information and confidentiality
In light of industry practice, the option to use either the mCTA (designed for direct contracting between pharmaceutical company sponsors and NHS hospitals) or the CRO mCTA (designed to be used where a clinical research organization contracts with an NHS hospital on behalf of a pharmaceutical company sponsor) has been retained.
While the new templates have officially replaced the 2011 versions, the ABPI has advised a pragmatic approach to implementation; for instance, if parties are already engaged in negotiations using the 2011 templates, there is no expectation to restart negotiations with the new templates. Similarly, it may take some time for both industry sponsors and NHS trusts to update their internal SOPs and guidelines to account for the changes to the mCTA templates.
The attraction of the UK as a clinical trial hub
The UK is a major hub for clinical trial research, with more than 665,000 people taking part in research studies in 2016-2017. Due to high demand for patients, 99 percent of NHS trusts and 48 percent of general medical practices actively engage in clinical research activities each year. Part of the attraction for sponsors to conduct paid clinical trials in the UK is the relative ease of recruiting patients, perhaps through online recruitment portals such as http://www.trials4us.co.uk/.
The mCTA was launched in 2003 in an effort to harmonise the contracting framework for clinical trials in the UK, with the aim of reducing the administrative time required to start a study. The mCTA has since gone through several revisions, with the last major update taking place in 2011. The templates are intended to be used without modification to ensure that both industry sponsors and NHS hospitals abide by the same contracting standards.