We would like to draw your attention to today’s launch of the model Clinical Trial Agreement for pharmaceutical and biopharmaceutical industry sponsored research in primary care (Primary Care mCTA). This is the latest in the series of model clinical trial agreements developed by NIHR.
The model Clinical Trial Agreement for pharmaceutical and biopharmaceutical industry sponsored research in primary care (Primary Care mCTA) has been developed and agreed by the Association of the British Pharmaceutical Industry, the BioIndustry Association, a number of highly research-active general Practitioners, the British Medical Association, the Medical Protection Society and the UK health departments. The Health Research Authority supports the use of model agreements.
The Primary Care mCTA is designed to simplify and therefore speed up the process for signing off and initiating pharmaceutical and biopharmaceutical clinical trials involving patients in primary care. It is intended that the Primary Care mCTA is used routinely without modification by all pharmaceutical and biopharmaceutical industry sponsors of contract clinical research in which NHS patients are recruited in primary care. In such cases, no further review is necessary, saving money and time. The launch of this new agreement is another positive step to develop the NHS as a world class environment for health research, and its development demonstrates the willingness of GPs to collaborate on reducing the barriers to clinical research.
As with previous agreements, versions for England, Scotland, Wales & Northern Ireland can all be viewed at the following link on the UKCRC website:
HSC R&D Division