Breaking News on Contract Research, Manufacturing & Clinical Trials

Headlines > Clinical Development

Contract overhaul to speed UK trials

By Kirsty Barnes, 29-Nov-2006

Related topics: Clinical Development, Regulatory affairs

The turnaround time of clinical trials in the UK may soon speed up after the Department of Health (DH) announced a planned overhaul of the way contractual agreements are made.

The rule changes apply to the country's Model Clinical Trial Agreement and will affect industry-sponsored Phase I-IV contract trials run in the UK's National Health Service (NHS) hospitals.

It excludes Phase I trials in healthy volunteers.

Behind the revamp is the NHS itself, 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.

It is hoped that the new agreement between the NHS and the industry will now give drug manufacturers a clear framework to work with, which will allow trials to be initiated much faster.

In addition to fast tracking the R&D process, the move is designed to attract more clinical trial business into the UK, where the industry has notoriously been weighed down by red tape.

Previously, before a trial could start, a contract had to be agreed between the hospital trust and the sponsor, however, there was no standard "boiler plate" contract 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.

Under the new system, a standard contract template will be used in all cases and only very fundamental trial-specific changes, such as trial name and financial details, may be changed, Dr Mark Lewis, commercial research and clinical trials adviser at the DH told Outsourcing-Pharma.com.

"In this way the legal contract review process can be kept to a minimum, paving the way for much trials to start much more quickly."

Of course, the study must still first receive ethics committee and Medicines and Healthcare products Regulatory Agency (MHRA) approval before the it can start.

Nigel Edwards, director of policy at the NHS Confederation, which represents over 90 per cent of NHS organisations, told Outsourcing-Pharma.com: "This agreement is good news for patients and the NHS and will help Britain's position in the international clinical trials market."

"NHS organisations particularly welcome the improvements to the agreement including the protection of intellectual property and measures to prevent the process from being overly bureaucratic."

Commercial firms involved in clinical trials in the UK are equally thrilled.

"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. I look forward to its contribution to streamlining the R&D Approval process for clinical trials," said Craig Stevenson, director of Clinical Research at Pfizer Global Pharmaceuticals UK.

Liam O'Toole, chief executive of the UK Clinical Research Collaboration (UKCRC) agreed, adding: "The UKCRC recognises that ensuring efficient regulatory processes is a fundamental part of a building first class clinical research environment. The development of the model Clinical Trials Agreement is an important step in this process."