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Trials research administration simplified


The UK’s Department of Health has announced an agreement that will enable approved industry-sponsored clinical trials to start sooner in National Health Service primary care. A standard form has now been agreed for the pharmaceutical industry to use in seeking permission from NHS primary care trusts (PCTs) for clinical trials to start in GP practices, simplifying the administration of clinical research. This will mean that industry-sponsored clinical trials involving patients in primary care in the NHS can start sooner. The move follows the announcement last year of the model Clinical Trials Agreement (mCTA) for hospitals.

The latest agreement has been launched in partnership with the Association of the British Pharmaceutical Industry and the Bioindustry Association. The deal clarifies the way that PCTs and pharmaceutical/biotech companies will negotiate the start-up of clinical trials and will allow patients to be recruited more quickly and easily. In addition, expansion of a trial to cover additional GP practices will be a more straightforward process.

The agreement was developed by the Pharmaceutical Industry Competitiveness Task Force Clinical Research Working Group in association with the NHS R&D Forum (Primary Care Working Group), and it has the support of the National Research Ethics Service (formerly COREC).

National Electronic Library for Medicines 13/04/2007


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