The mICRA was developed by a working group led by NIHR`s Office of Clinical Research Infrastructure (NOCRI) and the Medical Research Council. Representatives from industry, academia, the NHS and the Intellectual Property Office worked with legal advice to develop a model agreement that could support all collaborative research scenarios. The organisations involved in the working group agreed on a favourable statement promoting its use in order to streamline the contractual process for collaborative research. If you have any questions about model contracts, contract drafting, and negotiations for clinical trials or collaborative projects in research, development and innovation, please contact Andrew Fox, Research Contracts Officer at HSC Innovations. All correspondence should be sent to ResearchContracts@innovations.hscni.net for further information and support. 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. In the past, a Model Clinical Trials Agreement (mCTA) pilot project that has taken place in this area has highlighted a number of challenges. Click here to learn more about the history of mCTA. 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. These model agreements apply to health services in England, Northern Ireland, Scotland and Wales; they replace the country-specific versions of 2011. The accompanying guidance notes provide further background information, an overview of changes from the 2011 versions, and additional information on how and under what circumstances the models should be used. In March 2020, a revised model of the Clinical Trial Agreement (mCTA) and the mCTA Clinical Research Organisation (CRO-mCTA) was published on behalf of the four UK countries and the UK Pharmaceutical Industry Association (ABPI). Proponents and CROs were encouraged to review and adopt the new models as soon as possible, allowing for a six-month transition period, after which previous versions of the models were not accepted in new IRAS submissions. The Association of the British Pharmaceutical Industry (ABPI), Health and Care Research Wales (HCRW), Health and Social Care Northern Ireland (HSC NI), the Health Research Authority (HRA, England) and NHS Research Scotland (NRS) adopted versions of the Commercial Model Clinical Trial Agreement (mCTA) and the Clinical Research Organisation Model Clinical Trial Agreement (CRO-mCTA) in March 2020. which were first published in 2003 and 2007 respectively. These model agreements were developed to streamline the approval process for commercial trials and should therefore be used without modification by sponsors conducting clinical trials on nhs/HSC patients in hospitals in the UK healthcare system. To address these challenges, the CCTCC mCTA Lead Working Group, with the support of Innovative Medicines Canada and its member companies, HealthCareCAN and many provincial clinical trial institutions, reviewed the CCTA text. While many innovative pharmaceutical companies (including members of Innovative Medicines Canada) are participating in an international Common Language Evaluation and Reconciliation (TransCelerate) initiative to address five controversial clauses in clinical trial contracts, the CLEAR clauses have also been made available for review. Click here to learn more about these current developments.
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 Model Clinical Trials Agreement for Primary Care (mCTA) sponsored by the biopharmaceutical industry has been developed and approved by the UK Pharmaceutical Industry Association, the BioIndustry Association, a number of GPs highly active in research, the British Medical Association, the Medical Protection Society and the UK Ministries of Health. The Health Research Authority (HRA) supports the use of model agreements. This agreement can only be used as a model for a retrospective non-interventional study in which the past is examined on the basis of information already available at the beginning of the study. The mCTA is funded by the sponsor and the institution (i.e., the participating organization) during which the CRO-mCTA is to be used if, in addition to these two parties, the sponsor enters into a contract with a CRO responsible for the management aspects of the on-site study. The role assigned to the parties continues to reflect the position of the RHS and the business community, which considers the sponsor as the controller of the personal data and the participating organization and the CRO as a subcontractor acting on behalf of the sponsor for the purposes of the clinical trial (clauses 6.2.1 mCTA and CRO-mCTA). 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 Model Clinical Trials Agreement (mCTA) of February 2018 and the Clinical Research Organisation Model Clinical Trials Agreement (CRO-mCTA) replace the country-specific versions and mark an important step towards streamlining the commercially sponsored study establishment across the UK healthcare system, thus avoiding unnecessary administration. 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. This clinical trial will be conducted at multiple sites under existing NIAID-sponsored contracts and grants. NIAID will act as the sponsor of the Investigational New Drug (IND) application.
NIAID contractors, fellows, research networks, clinical research sites or their investigators are not parties to this Agreement. The NHS and HSC ICPs should be established through a subcontracting agreement with the participating NHS and the HSC organisation supported by the PIC. Appropriate data processing agreements should be concluded using the model research agreement: The Model Industry Collaborative Research Agreement (mICRA), launched in February 2011, aims to support clinical research collaborations between the pharmaceutical and biotechnology industries, universities and NHS organisations across the UK. . . .