If a model based on the model agreement is submitted but contains changes, the sponsor must explain the reasons. The mCTA for industry-sponsored studies involving clinical research organizations (CRO-mCTA) has also been updated, along with the accompanying guidelines for mCTA and CRO-mCTA. Both agreements have been amended to reflect changes in legislation and guidelines, including the General Data Protection Regulation (EU) 2016/679 and the 2015 ABPI Guidelines on The Remuneration of Clinical Trials. These agreements facilitate the development of studies and reduce the time required to negotiate terms with proponents. Proponents, researchers and sites included in the models should follow specific guidelines. Revised in February 2018, the Clinical Trial Agreement (mCTA) and Clinical Research Organisation Model Clinical Trial Agreement (CRO-mCTA) models are designed to be used without modification for industry-sponsored studies of NHS/HSC patients in hospitals in the UK healthcare system. Primary care mCTA is designed to simplify and accelerate the process of approving and initiating pharmaceutical and biopharmaceutical clinical trials with primary care patients. It is expected that primary care mCTA will be used regularly and unchanged by all pharmaceutical and biopharmaceutical industry sponsors of contract clinical research in which NHS patients are recruited into primary care. In such cases, no further legal review is required, saving money and time. UK-wide Model Non-Trade Agreement (mNCA) January 2021 – The Model Non-Commercial Agreement (mNCA) is structured to meet the requirements of non-commercial sponsors and NHS (or other) bodies conducting the research. The mCTA is a standard contract that is to be used by clinical trial sponsors and NHS/HSC organisations without modification.
Previously, the 2011 version required separate agreements for each of the four nations – England, Scotland, Wales and Northern Ireland. The new model allows the use of a single agreement across the UK and streamlines the process for companies looking to conduct clinical trials across multiple sites. There are several different models of agreements, and you should use the one that best suits your type of studies and sponsorship agreements. For more information, visit the IRAS website. You can access the nationally approved standard research agreements for non-commercial and commercial research below. For studies approved by the RHS, the RHS Initial Assessment Letter (and the RHS Approval Letter) specify the appropriate agreement for each site type in a study. The document may be the Statement of Activities and Schedule of Events, an unchanged agreement template (e.B. mCTA) or another document provided by the proponent. Launched in February 2011, the Model Industry Collaborative Research Agreement (mICRA) aims to support clinical research collaborations between the pharmaceutical and biotechnology industries, universities and NHS organisations across the UK. Nationally approved model site agreements help speed up the contracting process for industry-sponsored studies conducted in the NHS by eliminating the need for site reviews and local legal arrangements. This allows trials to start earlier, improving the speed of industry-sponsored clinical trials and giving NHS patients faster access to innovative treatments.
The set of model site agreements is supported by guidelines that set out the objectives and provide details on how the agreement should be used in the development of clinical research contracts sponsored by pharmaceutical, biopharmaceutical or medical device companies. The most fundamental change is that the revised models apply to health services in England, Northern Ireland, Scotland and Wales, replacing the country-specific 2011 versions. Therefore, a single model contract for commercial clinical trials across the UK will be possible, eliminating unnecessary administration to conduct the same study across the UK. ABPI commented that „the new mCTA enjoys broad support from life sciences leaders within government across the UK for the potential to accelerate innovative research and development.“ New Department of Health model agreement raises questions about NHS relationship with industry The model clinical trials agreement for primary care research in primary care (mCTA) sponsored by the biopharmaceutical industry has been endorsed by the UK Pharmaceutical Industry Association, the BioIndustry Association, a number of general practitioners who are very active in research, the British Medical Association, the Medical Protection Society and the UK Department of Health. The Health Research Authority (HRA) supports the use of model agreements. Before a clinical trial can begin, it is important to reach an agreement between the parties establishing the respective responsibilities and obligations. In the UK, where the clinical trial is being conducted in the NHS, various model agreements, including mCTAs, have been developed as a standard contract accepted by both the pharmaceutical industry and NHS bodies. The aim is to simplify and therefore speed up the launch of studies with NHS patients in NHS hospitals. The models are intended for unchanged use, with the exception of information specific to the study. In practice, mCTAs are considered standard models, and it is difficult for the industry to propose changes without significantly increasing costs. The press release included a cheer from industry and academic leaders that Health Secretary Andy Burnham said „will mean patients will have faster access to effective medicines and treatments,“ a laudable goal. The benefits of not having to renegotiate many elements of clinical trial agreements for each sponsor, trial and center are obvious.
However, before adopting this agreement with open arms, we should look at what it actually says and what the deeper implications might be. In addition to the introduction of the new models, IRAS is putting in place formal mechanisms for feedback from NHS organisations on the content of the models and their use by sponsors and clinical research institutions. AbPI has also put in place mechanisms to obtain feedback from industry. The objective is for models to be updated as necessary to reflect changes in the regulatory and broader clinical research environment and to ensure that lessons learned are incorporated into guidelines, training and other means of communication. The mCIA aims to speed up the contracting process for studies funded by the medical device industry in NHS hospitals. It is supported by the Ministerial Medical Technology Strategy Group (MMTSG), the UK Department of Health, the National Institute for Health Research, the Association of British Healthcare Industries (ABHI), the NHS Confederation, the Medical Schools Council, the UK Clinical Research Collaboration, the NHS R&D Forum and the Institute for Clinical Research for use in an unchanged format. Participant Identification Centres (CCN-PIC) are NHS/HSC organisations that identify potential participants. In commercial contract research, NHS/HSC ICPs should be established through a subcontracting agreement with the participating organisation supported by the ICP. In the context of non-commercial research, the sponsor may request its participating organisations to create ICPs under the equivalent non-commercial subcontract. Alternatively, a template is provided that can be used if the non-commercial sponsor decides to contract its PICs directly.
An updated Model Clinical Trial Agreement (mCTA) has been published for industry-sponsored clinical trials involving patients in National Health Service (NHS) or Health and Social Services (HSC) hospitals in the UK. The triapartite agreement is intended for the case where the management of a commercial contractual clinical investigation is outsourced from the sponsor to a contract research organisation. The CRO mCIA is supported by the UK Ministries of Health, the National Institute for Health Research, the Association of British Healthcare Industries, the NHS Confederation, the Medical Schools Council, the UK Clinical Research Collaboration, the NHS R&D Forum and the Institute for Clinical Research. . . .