The new version of the Model Clinical Trials Agreement (mCTA) will allow a single model contract for commercial R&D to be used in England, Scotland, Wales and Northern Ireland, cutting out unnecessary administration to run the same study across the UK.
Unlike previous versions, the latest mCTA will be able to be used across the whole of the UK. It has also been updated to reflect current practice and regulations.
It is hoped that this updated agreement will be used by companies and NHS research sites without changes which will reduce the time for administration before clinical trials get started.
804 applications for commercial clinical trials were received by the Medicines and Healthcare products Regulatory Agency (MHRA) in 2016. The new Model Clinical Trials Agreement (mCTA) is set to come into force on 1 March 2018.
Although the February 2018 mCTAs replace the 2011 versions, it is expected that both Sponsors (CROs) and NHS/HSC organisations exercise pragmatism in managing the transition. Further information can be found on the IRAS site.
The newest mCTA is a result of joint working between the UK government and the bio-pharmaceutical industry – through the ABPI and supported by the Ministerial Industry Steering Group (MISG)*.
Sophie Gillmore, Chair of the ABPI’s Clinical Research Expert Network and a Clinical Project Lead at AstraZeneca UK welcomed the new mCTA on behalf of the pharmaceutical industry, saying:
“At present, companies have to spend time preparing contracts in each of the four nations of the UK for the same study. The new mCTA will negate this requirement and should result in a faster and smoother set up process of commercial studies across the UK. This is good news for research and development of new medicines and should ultimately benefit patients.”
The new mCTA has wide support from life science leaders in government across the UK for the potential it has to speed up innovative research and development.
Ricky Verrall, Head of Chief Scientist Office of the Scottish Government, said:
“Scotland has been at the core of negotiations to develop the new model Clinical Trial Agreement (mCTA). Delivering a single UK agreement streamlines the research environment across the whole of the UK and improves our international competitiveness.
“This collaborative approach is an important step forward and supports our ongoing commitment to create an efficient, supportive and enabling environment for industry-sponsored trials.”
Dr Janice Bailie, Assistant Director of the Health and Social Care R&D Division, Northern Ireland Public Health Agency, said:
“The work done with the commercial sector to revise this model agreement will be invaluable for Northern Ireland – Health and Social Care Trusts and commercial sponsors can rapidly sign off contracts so that trials can get underway, giving patients earlier access to innovative new investigative treatments.”
Professor Jon Bisson, Director of Health and Care Research Wales, said:
“In Wales, we have worked alongside our commercial and UK government colleagues to develop a model agreement that will make a major contribution to improving the speed, ease and efficiency of high quality research for the benefit of patients. The collaborative approach commends the routine, unmodified use of the model Clinical Trial Agreement and we endorse its use.”
Teresa Allen, Interim Chief Executive of the Health Research Authority – a non-departmental government agency which oversees unified national system for the governance of health research, sponsored by the UK Department of Health and Social Care – says:
“This is an important update, streamlining the system across the UK. The UK remains committed to delivering world-leading set-up timeframes for high-quality research, and work like this is central to that. We look forward to continuing to work with our UK colleagues, the ABPI and other stakeholders, to see the mCTA maintained as a trusted document for unmodified use by sponsors and NHS sites.”
You can find the revised model clinical trial agreement and guidance notes in our directory of resources.