Pharmaceutical industry-sponsored clinical trials involving patients in UK National Health Service hospitals will now be able to start more quickly, thanks to a new agreement which has been launched in partnership between the NHS, industry associations and other groups.
Revisions to the existing model Clinical Trials Agreement (mCTA), which covers industry-sponsored drug contract trials in NHS hospitals, have removed the need for individual site-by-site reviews in order to negotiate agreement for a trial. Instead, a single agreement will be used across the NHS.
“This updated agreement will mean patients getting faster access to effective drugs and treatments,” said Health Minister Andy Burnham. “The NHS will also save money by reducing bureaucracy, as this single agreement can be used by all Trusts,” he added.
The Department of Health (DoH) acknowledges that the old system was time-intensive and costly because of additional legal fees. The new mCTA will give both NHS Trusts and pharmaceutical and biotechnology companies a clear framework to work with, which will also help to speed up trial initiations, the DoH adds.
The mCTA covers Phase I-IV drug trials in NHS hospitals (but specifically excludes Phase I trial in healthy volunteers), and is put in place once the trial has received Medicines and Healthcare products Regulatory Agency and ethics committee approval. The new streamlined version is part of a comprehensive package of measures announced in the government’s new health research strategy, Best Research for Best Health, which was launched in January with the aim of making the UK “the best place in the world for health research, development and innovation,” according to government spokesmen.
One of the partners in developing the new agreement is the Association of the British Pharmaceutical Industry, whose medical director, Dr Richard Tiner, welcomed it for bringing together the industry, the DoH and the NHS Confederation in “ensuring that UK clinical research is competitive with the rest of the world.”
“By all the parties using it without modification, clinical trials will start faster and thus more UK patients will have the opportunity to use new medicines in a closely controlled environment,” Dr Tiner added.
Aisling Burnand, chief executive of the BioIndustry Association, said the agreement’s universal endorsement was “a tremendous achievement which will strengthen the UK’s position as a world-leading location for medical research,” while Craig Stevenson, director of clinical research at Pfizer Global Pharmaceuticals UK, described its development as ‘a truly collaborative process.” He added: “I look forward to its contribution to streamlining the R&D approval process for clinical trials.”
