Before a clinical trial can begin, it is important to have an agreement between the parties defining the responsibilities and commitments. In the United Kingdom, where the clinical trial is conducted in the NHS, different types of agreements, including MTIIs, have been developed in the form of a standard form contract, accepted by both the pharmaceutical industry and NHS bodies. The goal is to simplify and accelerate the launch of studies on NHS patients in NHS hospitals. Models must be used without modification, with the exception of test-specific information. In practice, MCCs are considered standard models and it is difficult for the industry to propose changes without significantly increasing costs. Currently, companies in each of the four countries are required to prepare contracts for the same study, but the revised models will allow the use of a single research and business development contract in England, Scotland, Wales and Northern Ireland. Launched in February 2011, the Model Industry Collaborative Research Agreement (MICRA) aims to support cooperation in clinical research involving the pharmaceutical and biotechnology industries, universities and NHS organisations in the UK. For HRA-authorized studies, HRA`s initial evaluation letter (and HRA authorization letter) specifies the corresponding agreement for each type of site in a study. The document may refer to the declaration of activity and the timing of events, to a model of agreement (for example. B mCTA) or another sponsor document.
Guidelines for new published models indicate that MCTAAs and CRO-mCTAs are constantly monitored. We can therefore see other desirable changes in the next version of the models and perhaps new changes in response to the challenges that highlight the current circumstances. Moreover, given the UK`s exit from the European Union, it would have been desirable for the revised proposals to contain language that explicitly refers to UK and UK legislation, thereby providing adequate protection after Brexit. The adoption of this more robust literature is particularly welcome in the current climate and is an important step forward in addressing the need to streamline clinical trials related to COVID-19. This need is also reflected in the accelerated authorisation procedure for COVID-19 studies, which is now only 24 to 72 hours from about 80 days. Like the 2018 models, HRA expects the new mCTA and CRO-mCTA to be used without modification. The NHS and HSC NSCs should be established through a subcontracting agreement with participating NHS and HSC organizations.