Jonathan Sheffield

Transcript

1. Dr Jonathan Sheffield OBE Chief Executive Officer National Institute for Health Research Clinical Research Network
2. The growing imperative to provide evidence of clinical effectiveness- Opportunities for Industry collaboration. Dr Jonathan Sheffield, CEO, NIHR Clinical Research Network
3. Innovation is not new… • Both research and innovation are enshrined in the seven key principles that guide the NHS in all it does “The NHS aspires to the highest standards of excellence and professionalism… – Through its commitment to innovation – And to the promotion and conduct of research to improve the current and future health and care of the population” NHS Constitution BUT…
4. Cases /million: <6 6.1-12 12.1-18 18.1-24 24.1-30 30.1-50 Exeter 225 /million 1.6% diabetic clinic Shields et al Diabetologia 2010 With thanks to Prof Andrew Hattersley Trial in 2003: examined genetic testing for MODY subtypes. Proved that patients could replace insulin treatment with sulphonylureas and get better control 10 years later: despite research proof and availability of test, 90% of genetically- confirmed monogenic diabetes is still initially diagnosed as T1D or T2D An example of the challenge
5. New policy focus: adoption and diffusion • Report: December 2011 • Innovation the “the only way” to meet challenges of ageing population, increased capability, scientific advances, public expectation • NHS to demonstrate commitment to innovation through research support plus rapid adoption/diffusion of ideas, products, services, clinical practice • Academic Health Science Networks the vehicle for this to happen
6. Industry Imperative: Devices Directive • In order to be able to CE mark any device, a manufacturer must demonstrate that the stated device complies with the relevant Essential Requirements. To demonstrate such compliance, it will usually be necessary to provide clinical data, clinical data can consist of: • Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where there is demonstration of equivalence of the device to the device to which the data relates and the data adequately demonstrates compliance with the relevant Essential Requirements • OR a critical evaluation of the results of all the clinical investigations made • OR a critical evaluation of the combined data provided from the two bullet points above.
7. AHSN EoI document: June 2012 • Academic Health Science Networks… – A systematic delivery mechanism for local NHS, universities, public health and social care to work with industry to transform the identification, adoption and spread of proven innovations and best practice – Focused on a defined geography, operating across organisational boundaries – Needing to establish a set of relationships to transform care locally, by bringing together work on innovation with other levers, including research
8. A key relationship for AHSNs • National Institute for Health Research Clinical Research Network – Research delivery arm of the NHS – Operates England-wide to deliver national portfolio – Provides research nurses/clinical staff to recruit patients into suitable studies, carry out trial activities – Offers a clinical infrastructure and source of grass- roots knowledge that: • makes the NHS accessible to researchers (including commercial life-sciences researchers) • brings research opportunities to the patient bedside
9. Why is this relationship important? The AHSN policy says: • “A prerequisite for successful diffusion is first a supply of ideas, services and products that demonstrably adds value” • “Establishing the “added- value” of an innovation is critically important; not every idea deserves to be replicated • AHSNs will need to access the expertise in all parts of the local NIHR-funded research infrastructure The role of the CRN is: • To provide the infrastructure to allow good ideas to be systematically tested through clinical research • To provide the support needed on the ground to test the value of an innovation, to distinguish ideas worth spreading • To deliver research for patient benefit: patients can’t benefit if research is not implemented
10. Challenges we can we tackle together • Developing the appetite and ambition for clinical research activity across all therapy areas • “Academic Health Science Networks will play a key role in supporting research in the NHS across their geographies, working alongside Clinical Research Networks”… • Local Clinical Research Network will can provide data to the Academic Health Science Network to give a picture of research activity locally, and provide intelligence on the ideas pipeline
11. • 102 overlapping local networks will become 15, each covering research delivery across all therapy areas • Boundary alignment with AHSN areas • Will form strong working bonds with AHSNs • Increased efficiency within stable funding Note: map still in development and subject to change Network evolving at local level during 2013/114
12. The good news on “good ideas”… Sources: 2011/12 NIHR CRN annual report; Guardian Clinical Research Zone • Research is becoming more embedded • 99% of NHS Trusts now research-active • Progress with “hard- to-reach areas” Key: Red 0 to 50 studies Purple 51 to 100 Studies Blue 101 to 200 studies Yellow 201 to 250 studies Green 251 to 400 Studies NHS Trusts by number of studies recruiting patients in 2011/12
13. What does the NIHR CRN offer to Industry… 1.Support & Services • Protocol feasibility service from KOL & commercial investigators • Support with study start up & costing and contract negotiations • Service to identify investigators and research sites • Support with performance management of portfolio studies • Support with recruitment – Network ‘badging’ of portfolio trials to attract investigators & patients
14. What does the NIHR CRN offer to Industry… 2. Access • Access to NIHR Coordinated System for NHS Permission • Access to dedicated and trained network staff • Access to the NHS – clinician and patient population • Access to performance management resource nationally and locally
15. What does the NIHR CRN offer to Industry… 3. Tools • CSP – Gaining NHS Permissions • Med Tech Costing Template • Med Tech Route Map • model Clinical Investigation Agreement (mCIA) for Medical Technology Industry • Study Milestone Schedule
16. • A central contact centre for Industry applicants to NIHR CRN, regardless of therapeutic area or Network • A set of customer oriented service offerings, with clear timelines • Collaborative approach to feasibility and site selection • Early engagement ensures optimum opportunities for both sponsors and investigators • Tailored Clinical Review: at both a local and national level. Key Features of CRN Feasibility Services
17. 10 days 10 days 15 days
18. Channels of communication Online System to submit general enquires and studies for consideration Single contact number **0113 3434 555** Single email supportmystudy@nihr.ac.uk Communication @ Industry Information Centre
19. Challenge: speed of study set-up 0% 5% 10% 15% 20% 25% 30% 35% 40% End year 2011 End year 2012 End Sept 2012 End Dec 2012 Percentage of studies obtaining NHS Permission within 40 calendar days (from receipt of valid application form) Working hard to streamline and improve the system Focus should be on managing risk throughout life of study, not eliminating risk before start Centralized models and area-wide consortia approaches are delivering benefits. AHSNs could drive this.
20. Challenge: delivery to time and target Shows proportion of CRN Portfolio studies recruiting 100% of patient target within timescale Trend is improving, but consistency is key for research funders – especially life-sciences industry 0% 20% 40% 60% 80% 100% 120% End March 2011 End March 2012 Q1 12/13 Q2 12/13 Q3 12/13 Commercial Registered CTU Non-registered CTU
21. Conclusion • Economically Challenging times for all • Partnership working with the NHS and NIHR will bear fruit. • Opportunity is at its highest level ever in the NHS with Support, Access, and Tools easily available • THANK YOU