Faster Start Times For Clinical Trials Mean Better Treatment For NHS Patients
The Department of Health announced an agreement that will enable approved industry-sponsored clinical trials to start sooner in NHS 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. It follows the model Clinical Trials Agreement (mCTA) for hospitals announced last year.
The agreement is launched in partnership with The Association of the British Pharmaceutical Industry (ABPI) and the Bio Industry Association (BIA). It clarifies the way that NHS 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 additional GP practices will be a more straightforward process.
This agreement does not in anyway affect the safety of patient trials. It is about cutting bureaucracy, saving time and getting trials up and running faster so that patients can reap the benefits sooner.
The new PCT 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).
Director General of Research and Development Professor Sally Davies said: "This marks another positive step in our aim to develop the NHS as a world-class environment for research for the public interest working with industry. It is part of our 'busting bureaucracy' work and is in line with the commitments set out in the Government's health research strategy, Best Research for Best Health."
Richard Tiner, Medical Director, The Association of the British Pharmaceutical Industry said: "This is yet another success for the Pharmaceutical Industry Competitiveness Task Force"
Aisling Burnand, Chief Executive of the BioIndustry Association said: "We welcome the use of this new agreement to facilitate the rapid sign-off of clinical trials involving medicines in primary care. This is a positive development which will be important for UK-based bioscience companies."
Professor Paul Wallace, Director of the Primary Care Research Network in England, said: "This agreement represents a significant advance in facilitating industry sponsored clinical trials in Primary Care."
This agreement is the latest positive addition to a programme of work which includes the development of commercial and non-commercial mCTAs and the research passport. It supports the policy on NHS Permission for R&D Involving NHS patients.