The National Institute for Health Research Clinical Research Network has welcomed today’s (11 January 2011) report by the Academy of Medical Sciences into simplifying the clinical research governance system, calling it “a shot in the arm for all those who have been working to reduce unnecessary red-tape around clinical research”.
The Academy of Medical Science’s report calls for urgent changes to be made to the regulation and governance of health research in the UK, to reduce unnecessary delays, bureaucracy and complexity, without compromising patient safety.
In November 2008, the Clinical Research Network introduced a new streamlined system for researchers seeking permission to run clinical studies in NHS sites on its own portfolio of research studies.This system has resulted in significantly reduced set-up times for many research studies*, and has been the driving force behind a 66% uplift in the number of patients participating in its portfolio of clinical trials.**
However, Dr Jonathan Sheffield, chief executive of the Clinical Research Network, agrees with the Academy of Medical Sciences that more could, and should, be done to simplify the system.Speaking about today’s report, he said:
"The Academy of Medical Science’s report is a shot in the arm for all those who, like ourselves, have been working to reduce the red-tape around clinical research.Maintaining the safety and rights of patients is paramount, but many researchers see the amount of regulation required to set up a study as akin to using a sledgehammer to crack a nut.We need a system that encourages a proportionate response.”
In addition to calling for a more streamlined system, the Academy of Medical Sciences report also called for a change in the culture of the NHS to embed health research as a core function.
Dr Sheffield commented, “We know from our own work that many NHS doctors, nurses and executives are passionate about research – but we accept that there are still many hearts and minds to be won over.Indeed, we will soon be launching a major strategy to engage NHS medical professionals, and convince them to work with us in breaking down the barriers to increased research activity, so that more patients can benefit from access to clinical studies."
Notes to editors:
The Clinical Research Network runs “CSP” – the Coordinated System for Gaining NHS Permissions.Using this system, the Clinical Research Network has run a pilot project to reduce the set-up times for commercial pharmaceutical trials in the North West of England.This has resulted in set-up times of just 54 days (compared with an industry benchmark of 80 days), and several studies being the first in the world to recruit a patient.
In 2010, patient recruitment into Clinical Research Network portfolio studies totalled 500,000, compared with 300,000 in 2009.