UK-wide life science leaders welcome new version of mCTA, notes ABPI

A new version of the model Clinical Trials Agreement (mCTA), aimed at speeding up clinical trials and medicines research, has been welcomed by life science leaders across the whole of the UK, according to the Association of the British Pharmaceutical Industry (ABPI).

In contrast to previous versions of the mCTA, this new one will enable a single model contract for commercial R&D to be used across the whole of the UK — England, Wales, Scotland and Northern Ireland. This should reduce administration burden when running the same trial across each nation of the UK.

Set to come into force from today (1 March 2018), it is hoped that this updated mCTA will be used by companies and NHS research sites without changes, which should also reduce the administration burden that has been experienced prior to a clinical trial starting.

“At present, companies have to spend time preparing contracts in each of the four nations of the UK for the same study,” stated Sophie Gillmore, chair of the ABPI’s Clinical Research Expert Network and a clinical project lead at AstraZeneca UK. “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.”

“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,” added Ricky Verrall, head of Chief Scientist Office of the Scottish government. “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.”

“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,” commented Professor Jon Bisson, director of Health and Care Research Wales. “The collaborative approach commends the routine, unmodified use of the model Clinical Trial Agreement and we endorse its use.”

“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,” explained 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. “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.”

The new agreement resulted from the joint work of the UK government and the biopharma industry — through the ABPI and with the support of the Ministerial Industry Steering Group (MISG).