The agreement will mean that drug manufacturers will have a clear framework to work with, which will allow trials to be initiated much faster. Previously trials could take a long time to start as individual reviews took place site by site to negotiate agreement for that trial. This was a time-intensive and costly procedure because of additional legal fees.
The Department of Health commented that the agreement would also mean that patients will get faster access to treatments and the NHS will save money.
The agreement is launched in partnership with the NHS, The Association of the British Pharmaceutical Industry (ABPI) and the Bio Industry Association (BIA).
“I welcome the launch of the revised model clinical trial agreement today because it brings together the industry, the Department of Health and the NHS 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,” said Dr Richard Tiner, Medical Director of the ABPI.
“Pfizer welcomes the publication of the new model clinical trial agreement,” said Craig Stevenson, director of clinical research at Pfizer, UK. “I look forward to its contribution to streamlining the R&D approval process for clinical trials.”
The agreement should ensure more clinical trials take place in the UK. Research and development in healthcare currently contributes in excess of GBP3 billion to the UK economy.