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The Clinical Research Network

The Clinical Research Network . Improving the performance of commercial studies in the NHS. Structure and coverage. The Clinical Research Network is made up of eight Clinical Research Networks that provide full geographical coverage of England. Support.

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The Clinical Research Network

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  1. The Clinical Research Network Improving the performance of commercial studies in the NHS

  2. Structure and coverage The Clinical Research Network is made up of eight Clinical Research Networks that provide full geographical coverage of England

  3. Support • The Clinical Research Network supports the Life-sciences Industry through: • Assessing study feasibility • Administering study set-up • Providing resources for study delivery • Performance management

  4. Benefits • A unique position within the clinical research community enables the Clinical Research Network to provide: • A single point of access to the NHS and its …patient population • 103 Local Research Networks delivering site-support ......throughout England • Performance-related funding that drives set-up and ...delivery

  5. Services • The Clinical Research Network helps companies to make the most of the NHS through a range of services: • A centralised approval system - streamlines NHS Permission ...and drives down set-up times • Study and protocol feasibility checks from key opinion leaders …and active commercial researchers • A match-making service for your study with a diverse ...range of researchers and sites across all clinical ...specialities • Support with study start-up and costing/contract ...negotiations using standard templates • Specialist research staff and support services to assist with …study delivery at site level

  6. Recruitment The Clinical Research Network is getting stronger. In 2009/10 it recruited 14, 819 patients to adopted commercially sponsored studies across the UK – a 111% increase on the previous year. 14,8192009/10 7,0132008/09 3,5042007/08

  7. The NIHR Clinical Research Network Exemplar Programme

  8. What is the Exemplar Programme? • It is the final phase of the North West Exemplar Programme, which was initiated by the NIHR NHS/Biopharmaceutical Industry R&D Leadership Forum in summer 2009 • The North West Exemplar Programme facilitated rapid study set-up and recruitment to 18 commercially-sponsored clinical research studies • Results were achieved using established systems which have been put in place nationally since the introduction of the Clinical Research Network • The Exemplar Programme is overseeing the roll-out of recommendations born out of this project

  9. Why was the North West • Exemplar Programme initiated? • To demonstrate the NHS can compete with Europe in the delivery of high-quality, commercially-sponsored clinical research • Who took part? • 13 pharmaceutical companies - including BoehringerIngelheim, GSK and Novartis – and two contract research organisations • NIHR Clinical Research Network Coordinating Centre • All North West NIHR Clinical Research Networks • NHS North West and all North West NHS Trusts and PCTs

  10. Key results *This figure was an accurate reflection of the median set-up time for all studies on the NIHR Clinical Research Network Portfolio as of August 2010.

  11. “Capturing the learning” • A sub-project called “Capturing the learning” used interviews with key participants to identify good practice, which led to recommendations for each stakeholder group: • NHS leaders • Life-sciences Industry • Clinical Research Network and site staff

  12. Your recommendations • Process • Approach the Clinical Research Network as soon as possible when considering feasibility study • Plan a teleconference or meeting with the Principal Investigator, R&D and Network staff at site, early in the process, before the site is selected • Agree achievable recruitment targets with Networks for each site during feasibility

  13. Your recommendations • Communication • Obtain clarity on roles and responsibilities of staff involved in the trial, including Network staff • Provide Networks and sites with one point of contact (if possible). Also, provide names of back-up contacts to prevent delays • Have clear communication with Network and Site staff about competitive recruitment around the globe

  14. Your recommendations • People • Ensure Industry personnel involved in the study are clear about the role of the Lead CLRN, especially with regard to CSP • Involve senior stakeholders within Industry, for example the Head of Clinical Operations/Medical Director, and within the NIHR Clinical Research Network for rapid escalation of extraordinary issues

  15. Key messages Exemplar performance is achievable by: • Early engagement, when considering feasibility, with the Clinical Research Network Coordinating Centre • Close working between sponsor, Clinical Research Network and NHS site staff • Effective use of existing tools and systems • Facilitating a rapid escalation process to remove barriers (if they arise)

  16. Study start-up route map One of the recommendations outlined by the Exemplar Programme was a need for clarity regarding the roles and responsibilities of staff involved in the delivery of studies. The Clinical Research Network has developed the study start-up route map to help you and commercial partners identify who does what throughout the set-up and delivery of a study. The map is available at supportmystudy.nihr.ac.uk

  17. Key success factors

  18. Next steps Embracing collaboration ensured high performance in the North West Exemplar. To replicate this success throughout the rest of England, we need your help in supporting Programme recommendations and making them business-as-usual within the clinical research community. The roll-out of Programme recommendations is supported by a broader package of NIHR initiatives designed to accelerate the set-up and delivery of clinical research studies within the NHS. These initiatives include:

  19. NIHR Research Support Services (RSS) - the consistent and risk-proportionate framework for research management • NIHR Coordinated System for gaining NHS Permission (CSP) - the streamlined local procedure to issue NHS permission • Regulatory Governance Advice Service- the national front line advice service, linked to national experts on regulatory processes, approvals and permissions • Research Passports and HR Good Practice Guidance - the unified administrative procedure for research staff.

  20. Contacts • For more information on how the Clinical Research Network can help improve the performance of your study, please contact the Clinical Research Network’s specialist Life-sciences Industry Team: t: 0113 343 0397 e: crncc.industry@nihr.ac.uk Alternatively, visit the Clinical Research Network website for more information: supportmystudy.nihr.ac.uk

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