UK introduces new agreement to speed up clinical trials and medicines R&D

Evotec and Sanofi to combat infectious diseases
Credit: Viacheslav Lopatin

Life Science leaders have welcomed a new agreement that promises to make it easier for life-changing medicines and vaccines R&D to take place across different parts of the UK.

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).