Increasing Competitiveness in Clinical Research. November 2011

Transcription

1 Increasing Competitiveness in Clinical Research November 2011

2 Introduction The UK is witnessing a transformation in the number and qualityof clinical trials conducted in the country. This transformation has been brought about by improvements in the infrastructure of the NHS clinical trials facility The advantages flow to the patients, the health providers anddrug developers

3 The National Health Service

4 National Health Service The National Health Service was set up in 1948 to provide cradle to grave medical care, free to users at the point of access. Under continual review and assessment Every week Over 800,000 treated in outpatient clinics 1.4 million people helped at home 700,000 visit to an NHS dentist Over 10,000 babies delivered NHS ambulances make over 50,000 journeys NHS Direct receive over 25,000 calls Pharmacists dispense c 8.5m items 1,200 hip and 3,000 heart operations

5 2010 NHS White Paper

6 NHS White Paper -1 The core role of research in the NHS: "The Government is committed to the promotion and conduct of researchas a core NHS role". (para 3.16) The importance of clinical research and NIHR: "The NHS has an increasingly strong focus on evidence-based medicine, supported by internationally respected clinical researchers with funding from the National Institute for Health Research". (para 1.6)

7 NHS White Paper -2 The Government's commitment to partnership between NHS and Universities: "The Department will continue to promote the role of Biomedical Research Centres and Units, to develop research and to unlock synergies between research, education and patient care." (para 3.16) The importance of industry in the context of research: "A thriving life sciences industry is critical to the ability of the NHSto deliver world-class health outcomes". (para 3.16)

8 NHS White Paper -3 Results The success of NIHR Clinical Research Networks: Our patient participation levels in cancer research are the highest in the world. (para 1.6)

9 2011 Plan for Growth

10 Government s Plan for Growth Announced in the 2011 Budget Highlighted that health research has a key role in the national economy The Government wants to create the right conditions for businesses to succeed, removing barriersthat are preventing them from performing to their full potential. A thriving life sciences industry is critical to the ability of the NHSto deliver world-class health outcomes. For that to continue, we need to maintain a thriving research base.

11 Ideas into Practice

12 What Does Industry Need? Early-phase clinical research Later-phase clinical research Learn (fail early) Confirm (fail rarely) Delivery to time, budget and quality Shorter timelines 11/14/2011

13 What Can the UK Offer Industry? World leading science World class facilities NHS patients National Institute for Health Research 11/14/

14 The NIHR Health Research System Investigators & Senior Investigators Faculty Trainees Associates Infrastructure Clinical Research Networks Clinical Research Facilities, Centres & Units Universities NHS Trusts Patients & Public Research Research Projects & Programmes Research Schools Research Governance Research Information Systems Systems Systems

15 NIHR Infrastructure the support and facilities the NHS needs for first class research

16 NIHR Research Infrastructure Relevant infrastructure is established to support industrial clinical research at all points in the development pipeline Invention Evaluation Adoption Early-phase clinical research Later-phase clinical research NIHR Biomedical Research Centres NIHR Biomedical Research Units Clinical Research Facilities Experimental Cancer Medicine Centres Clinical Research Networks

17 NIHR Research Infrastructure Invention Evaluation Adoption Early-phase clinical research Later-phase clinical research NIHR Biomedical Research Centres NIHR Biomedical Research Units Clinical Research Leaders Facilities in scientific translation across a wide range of disease and therapeutic areas Experimental Cancer Based Medicine within the Centres most outstanding NHS and University partnerships in the country. Provide a direct route to work with leading investigators and clinicians with the expertise to translate Clinical fundamental Research biomedical Networks research into new and improved therapeutic approaches

18 NIHR Research Infrastructure NIHR Biomedical Research Centres * Specialist BRCs NIHR Biomedical Research Units Newcastle* Manchester* Liverpool* Oxford Marsden* Cambridge Imperial University College Great Ormond St* Moorfields* Guy s & St Thomas Maudsley* Leeds Musculoskeletal Liverpool Gastrointestinal Sheffield Cardiovascular Musculoskeletal Birmingham Gastrointestinal Bristol Cardiovascular Southampton Nutrition, Diet, Lifestyle Respiratory Nottingham Hearing Respiratory Gastrointestinal Leicester Cardiovascular Oxford Musculoskeletal Imperial Cardiovascular Respiratory Barts & London Cardiovascular

19 NIHR Research Infrastructure Invention Evaluation Adoption Early-phase clinical research Later-phase clinical research NIHR Biomedical Research Centres NIHR Biomedical Research Units Clinical Research Facilities Experimental Cancer Medicine Centres Dedicated research facilities for early-phase volunteer and patient studies. Run by experienced researchers, Clinical research Research nurses Networks and support staff Provide assistance throughout the research process from trial design through to data collection and study management.

20 NIHR Research Infrastructure Invention Evaluation Adoption Early-phase clinical research Later-phase clinical research NIHR Biomedical Research Centres NIHR Biomedical Research Units Eight Clinical Research Networks Operate across all areas of disease and clinical Clinical Research need Facilities Experimental Cancer Medicine Centres Work together to facilitate the delivery of high quality clinical research across the country Clinical Research Networks

21 NIHR Clinical Research Networks NIHR Dementias Research Network NIHR Diabetes Research Network NIHR Medicines for Children Research Network NIHR Mental Health Research Network NIHR National Cancer Research Network NIHR Primary Care Research Network NIHR Stroke Research Network NIHR Comprehensive Clinical Research Network

22 NIHR Clinical Research Networks A single point of contact for all Network research services Study and protocol feasibilityfrom key opinion leaders and active commercial researchers Access to a streamlined systemfor obtaining NHS permission for R&D approvals Support with study start-up processes, including costing and contract negotiations using standard templates Dedicated and trained Research Network staffto ensure study delivery at site level Research Network 'badging' of trials to attract both investigators and patients

23 NIHR Office for Clinical Research Infrastructure (NOCRI) Supporting research partners Sign-posting Helping researchers and research funders navigate NIHR infrastructure Research Collaboration Facilitation Actively supporting research collaborations from finding world-leading expertise in the NIHR, NHS and Universities for research customers, through to facilitating collaborations

24 Experimental Medicine Resource Finder Provides detailed information on all public and charity funded earlyphase facilities in the UK Searchable database with multiple search terms Includes information on: Research/disease areas Facilities in-patient/clinical; laboratory Omics Imaging Biorepositories Routesofaccess Launches end of November

25 Experimental Medicine Resource Finder Translational Research Partnerships Resource Finder Contact Us Get Listed Translational Research Partnerships

26 Interaction with Industry

27 Scale of the Opportunity for Industry Access via a single point of entry to world class science in world leading institutions and patients across the NHS

28 Nature of Collaboration Contract Commercial Research Academic Research Academic Led Collaboration Industry Led Collaboration Industry Collaborative Research Parties agree the work is collaborative Joint planning, study design, resourcing, ownership and control of data

29 Translational Research Partnerships Translational Research Partnerships offer a unique approach to support open innovation and collaboration with life sciences industries Collectively they bring together formidable expertise and capabilities: Recognised experience in current protocols, expertise in disease mechanisms, expertise in modelling Enabling technologies and infrastructure, including imaging, biobanks, accredited laboratory facilities Cohorts of well-characterised patients available for clinical development studies The Partnerships are supported by efficient business processes, using standard contracts and unified operating procedures

30 Inflammatory Respiratory Disease

31 Joint & Related Inflammatory Disease

32 Conclusions The UK is going through a transformative processin re-enginering its clinical practices. The creation of an integrated infrastructurehas been the most significant operational change. Changes take time, and require drive and determinationat all levels of the clinical trial operational pipeline. The intention is to make the UK a world-class Centre of Excellencefor clinical trials. The UK s experience can provide valuable lessons for other countries 32

33 Thank You Aitäh

34 Contact Details Nigel Whittle PhD MBA Technology Specialist Life Sciences UK Trade & Investment 1 Victoria Street London SW1E 6SW M: +44 (0) T: +44 (0) E: nigel.whittle@uktispecialist.com W: UK Trade & Investment is the Government organisation that helps UK based companies succeed in international markets. It also assists overseas companies to bring high quality investment to the UK's vibrant economy.