An “unstable” climate for clinical trials in the UK has seen the country’s share of global patient enrolment drop from 6% in 2000 to 2% in 2006, according to a recent working party report for the Royal College of Physicians (RCP).

In a global ranking of overall national effectiveness for clinical trials, based on an analysis of patient pools, cost efficiency, regulatory conditions, relevant experience, infrastructure and environment, the UK now ranks equal sixth with the Czech Republic after the US, China, India, Russia and Brazil, notes the report from a multi-sectoral working party convened by the RCP and chaired by Richard Horton, editor-in-chief of The Lancet.

Moreover, this decline comes at “a highly significant moment for clinical research” in the UK, the report comments. “There is more investment, stronger scientific leadership and greater political will behind biomedical research than at any time in recent history.”

At the same time, though, there are “serious gaps” in the country’s research community: a lack of well-qualified science graduates, deficiencies in in vivo research skills and difficulty in sustaining clinical trials, points out Innovating for health: Patients, physicians, the pharmaceutical industry and the NHS.

“Part of the difficulty has been the weak incentive system in the NHS to support research,” the report says. “Collaboration between the private and public sector has been fragmented. The NHS needs more muscular research leadership – clinically and managerially – together with a better alignment of incentives to promote and sustain research and research careers.”

Damaging directive

Part of the problem is “the inadvertent damage caused by the EU Clinical Trials Directive”, the report suggests, adding: “Although the purpose of the directive in 2001 was to make research easier to conduct, it has achieved exactly the opposite outcome”.

The regulatory bureaucracy around clinical trials “has rendered the UK too slow in execution and delivery compared with other countries”, the working party warns. It cites one study that had already been completed and closed in other, non-UK centres by the time it received clearance to start in the UK.

The clinical research networks set up to help foster a more positive environment for trials in the National Health Service “have not yet delivered on their promise”, the working party reports. One industry leader who submitted evidence described the attitude of the NHS to clinical research as “pitiful”.

Aggravating these difficulties are “strained” relationships between the pharmaceutical industry and clinical research groups in universities or the NHS. “This is partly because of prevailing concern that the academic and clinical community loses its independence and authority through industry collaboration,” the report comments.

“Yet research commonly shows that individual academics have deep links with pharmaceutical research and development. The conclusion drawn frequently is that these multiple ties to industry are harmful and should be discouraged. On the contrary, if the UK is to accelerate a leadership position in Phase I and II (translational) research, such collaborations need to be assembled with urgency.”

Among the working party’s recommendations for addressing these issues are that:

- NHS leaders, regulators, research funders, industry and academia must “endorse and encourage more strongly and publicly a research culture in the NHS that is centred on improving the quality of patient care”.
- Every NHS and primary care trust should have a designated ‘research champion’ on its board, whose objective would be to advocate for research within their organisation and encourage “a culture where research is fruitfully and productively completed, including with industry”.
- Bodies charged with allocating resources based on research output, such as the Higher Education Funding Council, should do more to recognise and reward academic-industry collaborative research, especially clinical trials.
- The Medical Research Council and the Economic and Social Research Council should team up to fund the monitoring of outputs from different research funding models, particularly those with industry, in order to optimise conditions for research and development of new medicines to fulfil unmet clinical needs.