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Yes, we can!

Although it may have a difficult road to tread, the UK can regain its position as a global leader in clinical research

Ask the medical director or head of clinical research at any pharmaceutical company conducting clinical research in the UK about their biggest barriers and they will shout: slow approvals, poor patient recruitment and cost. Commonly, companies fighting to include the UK in a global trial worry about the time it takes to gain NHS approvals, get the first patient into a site and get the site to deliver a respectable percentage of patients to target. Many fall at the first hurdle: often a UK site is closed as other global sites have already completed before the first UK patient has even been recruited. Although the picture is not pretty, we remain optimistic. Why?

Strategy for research in the NHS
The advent of the UK Clinical Research Collaboration (UKCRC) and formation of the National Institute for Health Research (NIHR) has brought innovation to the way clinical research is conducted in the UK. If you go through their adoption process, the Clinical Research Networks (CRNs) are one-stop shops for research, offering a single point of contact for industry studies, study feasibility assessment and support with patient recruitment. For those that opt for adoption, the NHS approvals process has been revamped with the introduction of the Co-ordinated System for gaining NHS Permissions (CSP), and a standard costing template and guideline tariff for routine use in CRN studies has been introduced.

The process of gaining ethical approval has been streamlined, and applications can be submitted via a single portal: the Integrated Research Application System (IRAS).

The NIHR is in the process of implementing Research Support Services (RSS) with a dual aim: to make professional the local management of health research through national standards for governance, incorporating a risk-based approach to assessment, and to collect and publish performance information. Key objectives are to eliminate duplication in the review process, to speed up approval decisions and to improve reliability and the quality of clinical research delivery.

Implementation at grass roots level
The myriad of recently initiated, ongoing and completed initiatives are a testament to the Government's belief in the advantages clinical research can afford the UK. Not only would it offer patients access to new and innovative medicines, improving the health of the nation, but the investment in clinical development would also help to boost the nation's wealth. The view from the top is rosy. Every effort has been made to answer the call to action to improve the UK's competitiveness in the clinical research arena.

The only problem is how all these initiatives will be implemented at NHS Trust level. We need to embed a culture of research throughout the NHS: at hospital level; investigator/doctor level; nurse level and administrator level. The initiatives require phenomenal co-ordination and co-operation between what are essentially independent business entities.

At a fundamental level, the chief executive officer (CEO) and lead managers of the Trusts need to be interested in clinical research. They need to recognise and appreciate the value research brings to their patients and the future revenue potential for the Trust, and ultimately the nation. Such initiatives are self-selecting of those that have the time and inclination for change.

After convincing CEOs and managers, the next hurdle is to change the way all NHS staff think about research. A shift in attitude, a new way of thinking and working, is needed: recognition for participating in clinical research and provision of time to carry out this work are key areas to address. Otherwise the last few years of developing a new strategy for research in the NHS will have been no more than a paper exercise. Innovative ways of working need innovative ways of communicating to grass roots staff to engage the crucial 'can do' attitude. This one change has the potential to make clinical research an NHS priority, resulting in the UK bouncing back to the forefront of clinical research — where it always should have been.

Dr Allison Jeynes-Ellis
The Author

Dr Allison Jeynes-Ellis is medical and innovation director of The Association of the British Pharmaceutical Industry (ABPI)

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20th May 2010


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