“The journey of a thousand miles begins with a single step” Lao-tzu (604-531 BC)

2. “The journey of a thousand miles begins with a single step” Lao-tzu (604-531 BC)

3. Invictus “I am the master of my fate I am the captain of my soul”

4. Introduction and overview of the Clinical Trials Theme Jeremy Kirk Clinical Director BBC CLRN Interim Theme Lead for Clinical Trials WMAHSN 16th December 2013

5. Mission Statement (www.wmahsn.org) • “The West Midlands Academic Health Science Network (WMAHSN) will create and support an environment in which the health and wealth of the population of the West Midlands can improve and prosper. Through creating a network that brings together inward investment, expertise, knowledge and energy from across the entire community, we will radically transform the way healthcare is both thought about and delivered”.

6. Mission Statement (www.wmahsn.org) • “The WM AHSN will help foster an innovative, region-wide culture of optimum engagement in clinical trials at all stages of the translation path from research to practice. The bringing together of key expertise and infrastructure under a region wide approach will provide the opportunity to increase the number of new trials initiated and improve the delivery of activity (quality and level of recruitment), aligned with the healthcare priorities of the West Midlands”.

7. Enabling themes Development of six enabling themes to drive clinical improvement throughout the region. • Innovation and adoption • Education • Clinical Trials • Digital Health • Wealth Creation • Integrated Care

8. Clinical Priorities • Mental Health • Long-terms conditions • Drug Safety and medicines optimisation

9. Clinical Priorities • “Our choice of priority long term condition topics reflects the demographics of the region, high quality academic and clinical leadership and research programmes, and the reflection of the new priorities in health care (summarised by the Lancet Global Burden of Disease conclusion), ‘The rising burden from mental and behavioural disorders, musculoskeletal disorders, and diabetes will impose new challenges on health systems’).

10. What can AHSN do? • Mapping between the enabling themes hopefully means the whole can be more than the sum of the parts.

11. From AHSN matrix: Clinical Trials • Deliver an increase in high quality trials led from the region through region-wide collaborations. • Harmonise RM&G systems in place across the region leading to rapid approval, set up and recruitment into trials. • Attract higher level of commercial trials activity from industry across the region. • Single Portal for trials site feasibility, contracting, approvals. • Increase PIs. • Data quality initiative in Primary Care.

12. Digital INTO • Establishment of e-portals. • Use of new digital IT-interface across the WM. FROM • Shared systems and governance. • Patient information. • Real-time data for implementation and monitoring.

13. Industry and innovation INTO • Increased industrial collaboration. • Income. FROM • Higher level of commercial trials activity from Industry.

14. Adoption and dissemination INTO • Evidence base. FROM • Increased take up and participation in trials.

15. Education and training INTO • Training for PI and subjects (participants). FROM • Support with education of organisations.

16. Integrated care INTO • Increased participation in trials and research. FROM • Link with trials across pathways.

17. Long-term conditions (LTCs) • Highlight research findings for adoption in patient pathways.

18. Timings for business plan 29/11Deadline for submission of plans. 13/12 Deadline for individual review of business plans, scored against specific criteria. 17/12 Review of scoring. 18/12 Due diligence on scoring feedback to theme & clinical leads, decision re. which to take forward to the Board. 20/12 Presentation of the agreed plans at the Board; 5 minutes per theme. 23/12 Feedback regarding approvals and funding. • Between 23rd December and 10th January discussions regarding next steps.

19. Clinical Trials Theme: Workplan for WMAHSN Year 1 • Increase the opportunities available for patients to participate in clinical research. • Make the West Midlands the destination of choice for industry partners and others to conduct their clinical trials, by removing bureaucracy and duplication at the expression of interest stage and recruiting to time and target. • Increase clinical capacity to set-up and deliver trials in the West Midlands and improve working links between the NIHR Clinical Research Network and Trusts (the delivery units) and the CTUs and Research Centres (the research generation units). • Develop digital platforms to secure more accurate identification of patient numbers and screening of patients for trial recruitment in secondary and primary care, and to support patient identification sites in primary care to refer more effectively to secondary care research sites.

20. Outcomes (1) • Increase recruitment of patients to both non-commercial and commercially sponsored clinical research. • Faster and more accurate information on feasibility to complete expressions of interest • 100% of expressions of interest turned around within 10 working days. Faster access to NHS sites for Industry partners, better collaboration between NHS sites to achieve industry targets. • Reduced time in negotiating contract terms and less variation through promotion and use of NIHR model agreements for both NIHR adopted and Non-Portfolio trials. • Numbers of PIs in West Midlands increased by 50% in two years in specialties with sufficient pipeline studies. • PI availability across all CRN specialty groups in all three West Midlands AHSN spokes.

21. Outcomes (2) • Increase in numbers of industry studies supported. • Faster recruitment to and completion of trials in the West Midlands. For 80% of NIHR Clinical Research Network studies to recruit to time and target by March 2014. • Increased access and choice for patients to become involved in research. • Increased levels of engagement in research among clinicians, creating a stronger environment for early adoption of research. • 100% of the Trusts in AHSN achieve their 70 day targets for study set-up/first patient first visit for all appropriate studies by March 2015.

22. Exemplar 1 • Support the Clinical Research Networks to establish a single portal for industry partners to manage feasibility (expression of interest) and study set-up.

23. Exemplar 2 • Support the CRN to increase recruitment numbers to trials and number of trials across the West Midlands in two years, by ensuring PI and CI availability in all CRN specialties in all three spokes.

24. Exemplar 3 • Initiate a data quality improvement programme in Primary Care, to support accurate recruitment of trial patients, and “live” data collection for research.

25. Cash! Portal Project Managers x3 £50,000 Development of digital platform £60,000* Pump-priming for modules £20,000 Research Facilitators x3 £25,000 Health Informatics Fellows x3 £50,000 Miscellaneous costs £15,000 Total £240,000 Includes £60k from Digital Theme*

26. Thank you!

27. Thank you! Any questions?