8 septembre 2021

« Scotland has been at the centre of negotiations for the development of the new Clinical Trial Agreement (MCTA) model. The establishment of a single agreement in the UK streamlines the research environment across the UK and improves our international competitiveness. « The work done with the commercial sector to revise this type of agreement will be invaluable to Northern Ireland – healthcare and social care trusts and commercial sponsors can quickly sign contracts so that they can start studies that allow patients to access innovative new investigative treatments sooner. » The HRA welcomed two new treaty proposals that will facilitate research and development of medicine and the development of life-changing vaccines in different parts of the UK. The Clinical Trial Agreement model for primary care research (Primary Care mCTA) sponsored by the biopharmaceutical industry has been developed and approved by the Association of the British Pharmaceutical Industry, the BioIndustry Association, a number of very active GPs, the British Medical Association, the Medical Protection Society and the UK Health Services. The Health Research Authority (HRA) supports the use of model agreements. Primary Care mCTA aims to simplify and thus accelerate the process of registering and initiating pharmaceutical and biopharmaceutical clinical trials in primary care patients. The intention is for the primary care mCTA system to be used in a routine manner without modification by all pharmaceutical and biopharmaceutical industrial sponsors of clinical research, in which NHS patients are recruited into primary care. In such cases, no further legal review is required, saving money and time. Launched in February 2011, the Model Industry Collaborative Research Agreement (MICRA) aims to support clinical research cooperation involving the pharmaceutical and biotechnology industries, universities and NHS organisations across the UK. « This collaborative approach is an important step forward and supports our ongoing commitment to creating an effective, supportive and supportive environment for industry-sponsored studies. » A model clinical trial agreement (mCTA) has been published for industry-sponsored clinical trials on patients in National Health Service (NHS) or Health and Social Care (HSC) hospitals in the UK. The MCTA has also been updated for studies conducted with industry-sponsored clinical research organizations (CRO-mCTA), as well as associated 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 ABPI Clinical Trial Compensation Guidelines 2015. The MCTA is a standard contract that must be used without modification by sponsors of clinical trials and NHS/HSC organisations.

Previously, according to the 2011 version, separate agreements were needed for each of the four nations – England, Scotland, Wales and Northern Ireland.

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