In February 2018, the Integrated Research Application System (IRAS) issued revised versions of the template model Clinical Trial Agreement (mCTA) and Clinical Research Organisation model Clinical Trial Agreement (CRO-mCTA, used where clinical research organisations undertake site management responsibilities on behalf of the sponsor). The new mCTAs are designed to be used without modification for industry-sponsored trials in the national health service (NHS), and have been updated to reflect current practice and regulations. The new mCTAs should be used from 1 March 2018.
Before any clinical trial can commence, it is important to have an agreement in place between the parties, setting out the relative responsibilities and obligations. In the UK, where the clinical trial will be run in the NHS, various template agreements, including the mCTAs, have been developed as a standard form contract accepted by both the pharmaceutical industry and the NHS bodies. The aim is to simplify and, therefore, speed up the initiation of studies involving NHS patients in NHS hospitals. The templates are intended to be used without modification, with the exception of trial-specific information. In practice, the mCTAs are seen as default templates, and it is difficult for industry to propose any amendments without considerable increased costs.
The changes to the 2018 versions are not substantial, and aim to reflect current guidance and legislation. The Guidance Notes accompanying the mCTAs provide further background, an overview of the changes, and information on how and when the templates should be used. The key changes to the 2018 templates are:
- The mCTAs are drafted in standard form to facilitate the uniform application across the UK, for example the term “NHS Trust” has been replaced with “participating organisation”.
- The mCTAs more clearly specify the responsibilities of the parties regarding managing consent as applicable to Principal Investigators and Sub-Investigators.
- The clauses dealing with freedom of information and confidentiality have been separated.
- References to legislation and guidance have been clarified to be clear which version is applicable to the trial (in most cases, the most recent version).
- The most recent version of the clinical trial compensation guidelines have been included. These guidelines provide a simple and quick procedure where clinical trial subjects are compensated for any injury that may occur as a result of the clinical trial, without the clinical trial subject having to go to Court to obtain compensation.
The most fundamental change is that the revised templates are applicable to the health services in England, Northern Ireland, Scotland and Wales, replacing the 2011 nation-specific versions. As such, a single model contract for commercial clinical trials will be possible in all of the UK, cutting out unnecessary administration to run the same study across the UK. The ABPI has commented that “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”.
Alongside the launch of the new templates, the IRAS is establishing formal mechanisms for feedback from NHS organisations on the content of the templates and their use by sponsors and clinical research organisations. The ABPI has also established mechanisms for obtaining feedback from industry. The aim is for the templates to be updated as necessary to reflect changes in the regulatory and wider clinical research environment, and to ensure that lessons learned are incorporated into guidance, training and other means of communication.