New clinical trials agreement to improve UK research
pharmafile | November 3, 2006 | News story | Research and Development |Â Â Â
The Department of Health has revised its routine contract for industry-funded NHS clinical trials as a way of improving their efficiency and enhancing the NHS international research credentials.
The model clinical trials agreement was first launched in January 2003 and the changes to it are designed to cut the cost of trials carried out in NHS hospitals and allow them to start sooner.
Health minister Andy Burnham said:" This updated agreement will mean patients getting faster access to effective drugs and treatments. The NHS will also save money by reducing bureaucracy as this single agreement can be used by all trusts."
The model clinical trials agreement (mCTA) was formulated by a joint team of medical and legal advisors from the DH, the NHS, industry associations the ABPI and BIA and a number of pharmaceutical and biotech companies. It is a standard contract for industry-sponsored phase I-IV clinical trials conducted in NHS hospitals, but cannot be used for phase I trials in healthy volunteers.
The voluntary agreement is designed to be used without amendment once a trial has gained MHRA and ethics committee approval, and is available in country-specific versions for England, Scotland, Wales and Northern Ireland to reflect differences in governance and legal arrangements.
Chief executive of biotech association the BIA Aisling Burnand said: "The universal endorsement of this agreement is a tremendous achievement which will strengthen the UK's position as a world-leading location for medical research."
Use of the template contract would "significantly accelerate the initiation of trials", she added.
The new mCTA followed a review of the original agreement by the Pharmaceutical Industry Competitiveness Task Force (PICTIF) commissioned in November 2005.
This aimed to put together a new version of the agreement that would incorporate regulatory changes, such as the development of foundation hospitals, and be acceptable to all companies sponsoring trials and the NHS hospitals carrying them out.
Craig Stevenson, director of clinical research at Pfizer Global Pharmaceuticals UK, welcomed the new mCTA.
"The development of this new agreement has been a truly collaborative process aimed at improving our ability to implement, in a timely fashion, commercially sponsored studies in the UK," he said.
A further version of the mCTA is currently in development for trials managed by contract research organisations and this is expected to be published in the next few months.
