Pharmaceutical industry-sponsored clinical trials involving UK primary care patients will now be able to get underway more quickly, thanks to a new partnership between the National Health Service, the government and industry.
The Association of the British Pharmaceutical Industry and the Bio Industry Association have reached agreement with the NHS and the Department of Health on a new standard form for manufacturers to use when seeking permission from NHS Primary Care Trusts to conduct clinical trials in general practice. As well as enabling a speedier start for trials, the agreement clarifies how pharmaceutical and biotechnology companies negotiate trial start-ups with PCTs, will allow patients to be recruited more quickly and easily and make the expansion of a trial to additional GP practices more straightforward, says the Department.
The initiative, which follows the model Clinical Trials Agreement put in place in October last year to enable industry-sponsored trials in NHS hospitals to start sooner, was developed by the joint industry/government Pharmaceutical Industry Competitiveness Task Force’s (PICTIF) Clinical Research Working Group, in association with the NHS R&D Forum (Primary Care Working Group). It supports the Department’s NHS Permission for R&D Involving NHS Patients policy and has the backing of the National Research Ethics Service.
A positive development for UK bioscience
Industry leaders have welcomed the new agreement, with ABPI medical director Richard Tiner describing it as “yet another success for PICTIF,” and BIA chief executive Aisling Burnand calling it "a positive development which will be important for UK-based bioscience companies.”
The partners stress that the initiative will not affect the safety of patient trials in any way. “It is about cutting bureaucracy, saving time and getting trials up and running faster so that patients can reap the benefits sooner,” said the Department.