Pharma Welcomes UK-Wide Applicability Of Revised Model Clinical Trials Agreement
Executive Summary
The pharmaceutical industry has welcomed the UK's updated model clinical trials agreement that sponsors can now use to rapidly sign off contracts when undertaking clinical trials in hospitals run by the national health services throughout the country.
The UK has issued updated templates of its "model clinical trials agreement" that pharmaceutical companies and contract research organizations can use, without modifications, for all industry-sponsored trials in National Health Service/Health and Social Care hospitals.
The revised templates are expected to speed-up the start of commercial trials in the UK as they will allow sponsors to sign off contracts more quickly so that trials can get underway. In 2016, the Medicines and Healthcare products Regulatory Agency received 804 applications for commercial clinical trials.
There are separate templates of the model agreement for use by pharmaceutical companies (mCTA) and CROs (CRO-mCTA). Although the updated templates came into effect on March 1, trial sponsors and NHS/HSC organizations are being advised to "exercise pragmatism in managing the transition."
The pharmaceutical industry has welcomed the revised model agreement as – unlike its earlier 2011 version – it can be used for trials across England, Northern Ireland, Scotland and Wales, "cutting out unnecessary administration to run the same study across the UK," the Association of the British Pharmaceutical Industry said in a statement.
Until now, companies have had to spend time preparing contracts for the same study in each of the four countries of the UK. The new model agreement "will negate this requirement and should result in a faster and smoother set up process of commercial studies across the UK," said Sophie Gillmore, chair of the ABPI's Clinical Research Expert Network and a clinical project lead at AstraZeneca UK.
The UK-wide use of the model agreement was made possible by using standard wording to take into account, where appropriate, any legal and administrative differences between the countries of the UK. For example, the agreements no longer refer to an "NHS Trust" as a contracting party, but to a "Participating Organisation."
Other key changes include:
- Updated data protection clauses: The responsibilities of the parties have been more clearly specified with respect to managing the consent process.
- Freedom of information and confidentiality: There are now separate clauses dealing with these issues.
- Declaration of Helsinki: There is clarity on which version of the Declaration of Helsinki would apply to a trial.
- Clinical trial compensation: The 2015 clinical trial compensation guidelines have been included as an appendix.
Users of the revised model agreement will not have to select specific provisions or make any other amendments to these clauses as the updated mCTAs have been drafted so that the relevant legislation/legal system applies, according to the collaborative UK initiative that runs the Integrated Research Application System (IRAS), which is a single system for applying for permission and approval for health and social/community care research in the UK.
The IRAS has also issued further guidance on how – and under which circumstances – the templates should be used. Apart from adding trial-specific information to the mCTAs, all the UK health departments strongly recommend that trial sponsors use the mCTAs without modification.
The IRAS and the ABPI have established formal mechanisms to obtain feedback on the new mCTAs from NHS/HSC organizations and the industry, respectively. The feedback will be considered by a group, which aims to ensure that the mCTAs are iterated as necessary, and that lessons learned in practice are incorporated into guidance, training and other means of communication.
Pragmatic Uptake
Urging pragmatism on the uptake of the new mCTAs, the IRAS said that any party to a contract negotiation that has already commenced on the basis of the 2011 version should not propose the use of the 2018 version where this would delay the contracting process.
Even where a sponsor has yet to propose a contract template to a site, the IRAS officials said: "We would expect that sites demonstrate pragmatism in continuing to accept unmodified 2011 versions whilst sponsors (and CROs) finalise their internal change management processes" to transition to the 2018 version.
The first mCTA was issued in 2003 and it only applied to trials conducted by pharmaceutical companies. (Also see "Clinical Trials" - Pink Sheet, 13 Feb, 2003.) The first version for CROs was published in 2007. The 2018 version is the result of joint efforts by the UK government and the bio-pharmaceutical industry, supported by the Ministerial Industry Steering Group.
From the editors of Scrip Regulatory Affairs.