BioWorld International Correspondent
LONDON - A new national agreement for clinical trials carried out in the UK's National Health Service will save money and enable trials to start sooner.
At present, proposed trials have to be reviewed and approved on a site-by-site basis, but in the future, a single agreement will be valid across the country.
Announcing the Clinical Trials Agreement, Health Minister Andy Burnham said it would save the NHS money by reducing bureaucracy. "[It is] a good example of the government, the NHS, universities and industry working together to enhance the UK clinical research environment."
The new agreement is for industry-sponsored trials in NHS hospitals, from Phase I to Phase IV in patients. It excludes Phase I trials in healthy volunteers.
Aisling Burnand, CEO of the UK BioIndustry Association, which helped to broker the agreement, said, "Use of this template contract will significantly accelerate the initiation of trials. The BIA fully recommends its use to our members and supports its widespread adoption."
Jonathan Michael, CEO of Guy's and St Thomas's Hospital in London, said the hospital would put the agreement into use immediately. "Having been involved in its development, we readily appreciate how much it will smooth the way for the faster and easier establishment of trials for the benefit of the NHS, our academic partners, the UK pharmaceutical industry and ultimately, therefore, the patients."
The new trials agreement is part of package of measures set out in the government's new health research strategy, "Best Research for Best Health," published in January. That set the objective of making the UK the best place in the world for health research, development and innovation.
Craig Stevenson, director of clinical research at Pfizer UK, said the development of the agreement had been a collaborative process, and it should speed up the start of commercial studies. "I look forward to its contribution to streamlining the R&D approval process for clinical trials."
As part of moves to improve the research environment for health research, the government previously set up the UK Clinical Research Collaboration to provide a single national framework for trials. Liam O'Toole, chief executive of the collaboration, said efficient regulatory processes are a fundamental building block of a first-class clinical research environment, adding the model agreement "is an important step in this process."
The government said the agreement would ensure more clinical trials take place in the UK. Clinical research costing around £3 billion (US$5.7 billion) per annum now is carried out in the UK.