Relevance of the Research: The £1.8 billion pa UK clinical research sector is under threat from global competition as delays in the conduct of UK trials have lead to some global pharmaceutical companies to conduct their trials elsewhere.  In 2005 the UK Government committed £100 million to the development of the UK Clinical Research Network (UKCRN) in order to directly address the “translational gap” between the development and application of novel treatments.  Reducing the time and costs of clinical trials is a major objective of this initiative and central to the ‘lean healthcare’ agenda involving development of new treatments (new drugs or novel procedures).

The Approach: The work was focussed on delivering the following key objectives:

• To map alternative models of clinical research and identify the key challenges they generate.
• To identify the barriers and enablers to clinical trials management in the UK clinical research sector.
• To identify the macro institutional factors (policies/economics) that help or hinder clinical trials management at the micro level.
• To develop new theory to deepen understanding of the processes involved in ‘networked innovation’, focusing on clinical research as an exemplar.
• To produce a report for a target audience of UK policy makers, Clinical Research Directors/Managers and focal professional groups focusing on requirements and recommendations for the successful management and organization of clinical trials in the face of current economic and policy constraints.

Partner Involvement: The following organisations supported the project through the provision of in kind resources, data, participation in interviews, questionnaires and workshops - Queen Mary University of London, Association of the British Pharmaceutical Industry, Institute of Clinical Research, BioIndustry Association, Warwick Clinical Trials Unit, Association of British Healthcare Industries, NIHR Clinical Research Network, Contract Clinical research Association, NHS R&D Forum and London Biotechnology Network.

Research Outputs:

The research found improvement in the proportion of projects that completed on time over the last decade. Projects led by pharmaceutical companies were significantly more likely to complete on time than those led by other kinds of commercial organization and by non-commercial research groups.

Major challenges affecting the management of all kinds of clinical research were found in four areas:

Regulation & Governance:

• The regulatory and ethical approval processes have improved significantly in recent years, with the introduction of ‘bureaucracy-busting’ measures such as the Integrated Research Application Scheme (IRAS).
• Changes to the governance system following the EU Clinical Trials Directive and Research Governance Framework have improved response time to submitted applications but not set-up time.
• All research groups, other than pharmaceutical firms, experience significant difficulty in obtaining information, completing paperwork and ensuring the features of their models of research correspond with the approval requirements for regulatory and R&D approval.
• NHS R&D approval, contract negotiation and the NHS research culture are considered to be major impediments to successful trials management.
• A ‘one-size fits all approach’ to approvals poses particular problems for ‘non-standard’ kinds of clinical research projects.

Knowledge & Expertise:

• The major predictor of success (completing projects on time, with sufficient patients and on budget) was the ability to retain a project team.   Skills shortages create particular difficulties for non-commercial and smaller commercial research organizations.
• A patchy NHS ‘research culture’ was considered a major impediment to UK clinical trials.
• Expertise of planning and designing of clinical research projects were more important factors for recruitment than incentives (financial or non-financial).

Networks & Strategy:

• Project management is reliant on the development of successful working relationships between the focal research organization and other key groups within the sector including charities and patient groups

Incentives & Drivers:

• Different types of research organisation have different priorities which influence their motivation in developing a clinical research project.  Financial reward was important for commercial groups. Research group reputation and informing UK policy were more important for non-commercial research.

Publications: The project has so far led to the publication of a detailed final report “Managing Clinical Research in the UK”, which has been circulated widely, a book and two peer reviewed journal papers.

Technology Transfer: The survey tool used is available for future use on request.

Notable Impacts:

• The project findings were presented to a UK Clinical Research Collaboration (UKCRC) Board meeting, chaired by Professor Dame Sally Davies, Director General of Research and Development and Chief Scientific Adviser for the Department of Health and NHS.
• As well as influencing policy, the research has had impact on the knowledge/understanding of the associations, professional networks and trials managers that participated.
• The findings were presented to an audience of 140 NHS and commercial trials managers via a dissemination event in central London held in September 2009).  As a result, the research has been reported more widely in healthcare publications and the general press and media.

Next Steps: There is potential in applying the survey instrument to trace trends in trials success and management over time, as changes in the regulatory/industry context occur. Further research could also compare UK trials management with that in other (competitive) nations in order to understand constraints posed by the UK national context and opportunities for future development.

Interested?  For further information please contact Jacky Swan, Professor in Organizational Behaviour, Warwick Business School, University of Warwick, CV4 7AL.

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