Public/private partnership improves UK’s clinical research competitiveness

A new report shows collaboration between the life sciences industry, the NHS and the National Institute for Health Research (NIHR) Clinical Research Network is enhancing the UK’s clinical research competitiveness₁.

The NIHR Clinical Research Network North West Exemplar Programme (NWEP) – supported by the NHS North West Strategic Health Authority, NHS chief executives and senior industry leaders – was initiated to demonstrate that the NHS could compete with Europe in the set-up and delivery of high quality, commercially-sponsored clinical research studies.

The NWEP Phase II Report shows that the 20 participating studies achieved a median set-up time of 54 days, which matches the best performance levels in Europe₂. Seven of the 20 studies recruited the first patient in the world, a key indicator of efficient study set-up and strong evidence that the Clinical Research Network is succeeding in streamlining research governance. Additionally, 18 of the 20 studies are on course to meet, or exceed, their patient recruitment target.

Dr Pim Kon, Vice President and UK Medical Director of GlaxoSmithKline, believes the Exemplar Programme has provided a strong template for a viable clinical research environment:

“The Exemplar Programme has demonstrated that the most effective way of competing with the rest of the world is for key stakeholders in UK clinical research to work together in a more collaborative way. We have the same agenda, which is to provide patients with early access to medicines and the long-term health and economic benefits this brings, and the Exemplar has helped to coordinate this commitment. GSK is encouraging all of our clinical study teams to embrace this collaborative agenda and, for the first time, share our global study metrics with academic investigators to give them a greater understanding of study performance.

“The Exemplar has certainly changed perceptions of the UK as a site for clinical research. It has shown what is possible with the right approach and is helping to make the UK more attractive to our R&D community, who are considering placing more studies in the UK as a result.”

The next phase of NWEP is the roll-out and adoption of recommendations from the Phase II Report across England. Recommendations include the monitoring and reporting of study metrics, to encourage collaboration and competition by making Trusts more aware of each other’s performance, and the rapid escalation of extraordinary issues to Trust chief executives to aid problem solving. Key stakeholders from the life sciences industry, NHS and the Clinical Research Network are now forming guidance groups to determine how roll-out can be achieved most effectively.

Dr Jonathan Sheffield, Chief Executive of the Clinical Research Network, believes it is vital for key stakeholders to continue working together to build on the success of NWEP. He says:

“Collaboration has proved crucial to Exemplar study successes and will remain so during the roll-out phase of the programme in 2011. We can only replicate the Exemplar culture in the rest of England if we retain the support and commitment of the clinical research community and we are currently working with project partners to ensure Exemplar recommendations become an everyday aspect of the clinical research landscape.”

Professor Dame Sally C Davies, Director General of Research and Development and Chief Medical Officer (interim)at the Department of Health, commented:

“The NHS White Paper reiterated the government’s commitment to clinical research, and its belief that a thriving life sciences industry plays a crucial role in the health and wealth of the nation. The NIHR Clinical Research Network North West Exemplar Programme has demonstrated that the NHS can compete with the best in Europe and we are looking forward to seeing this level of performance replicated throughout England so that commercial research can reach its full potential.”

References

1. Dr Allison Jeynes Ellis, Medical and Innovation Director at the Association of the British Pharmaceutical Industry (ABPI),“The ABPI recognises the importance of the Exemplar Programme as a showcase for clinical research in the UK. We are on a journey in terms of improving our competitiveness in clinical research and the continued collaboration between the pharmaceutical industry and NHS is vital to nurture the health and wealth of the nation.’Adrienne Clark – GSK UK Oncology Clinical Field Team Manager,“The Networks throughout the UK are aware of the high levels of performance that are being achieved in the North West and there has been a general improvement in their performance as a result. I feel there has been a definite change over the last six to nine months and I think it is the North West Exemplar glow that is taking effect.”
2. Median approval times (ABPI figures): Italy 49 days; Spain 70 days; France 56 days; Germany 56 days; Sweden 56 days.