An update to the contract negotiation system for hospital-based clinical trials has come into play in the UK - in a further effort to take some of the pain out of the process and speed up trial start-up times.
In addition to fast tracking the R&D process, the move is also designed to attract more clinical trial business into the UK, where the industry has notoriously been weighed down by red tape. The rule changes apply to the country's Model Clinical Trial Agreement (mCTA) and will affect industry-sponsored Phase I-IV trials that are being managed by contract research organisations (CROs) in the UK 's National Health Service (NHS) hospitals. Phase I trials in healthy volunteers are excluded. Under the new system, CROs who are negotiating contracts on behalf of trial sponsors will now be able to do so using a standard contract template - only very fundamental trial-specific changes, such as trial name and financial details, may be changed. The new system is an extension of an already-updated mCTA, introduced by the Department of Health late last year, whereby the trial sponsors have already been able to take advantage of the new contracting arrangement. Now, under the new tripartite agreement - the CRO mCTA - CROs are also included.
Prior to the mCTA overhaul last year, a contract had to be agreed between the sponsor/CRO and the individual hospital trust before a trial could start, however, there was no standard in place and both parties often added their own changes to the contract, creating a lot of tooing-and-froing. Because of this, trials could take a long time to start as each party had to review and negotiate the individual changes to the contract agreement for that particular trial. This was also a costly procedure because of the legal fees involved. Pushing for the mCTA revamp has been the NHS , The Association of the British Pharmaceutical Industry (ABPI) and the Bio Industry Association (BIA) - all who desperately want to improve efficiencies in the country's clinical trial industry.
Commenting on the update, Professor Sally Davies, director general of R&D at the Department of Health said: "This represents another important step in the development of the R&D Partnership between the NHS and the pharmaceutical industry. The use of this agreement by research managers in the NHS will help to implement the 'bureaucracy busting' agenda of the National Institute for Health Research..."