Navigating the Clinical Research Landscape in the NHS. How the Clinical Research Network can help you Generate the Evidence

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1 Navigating the Clinical Research Landscape in the NHS How the Clinical Research Network can help you Generate the Evidence Lydia Christopher Head of Industry Operations, NIHR Clinical Research Network

2 Why Clinical Research? CE mark permits marketing of product Clinical research generates robust evidence to prove product works Supports NICE technology assessment Swifter entry of innovation into the NHS

3 Where we fit in the NIHR Supports facilities for research (eg Biomedical Research Units) National Institute for Health Research The Clinical Research Network: We provide the practical support researchers need to run clinical studies in the NHS, so that more studies can happen, and more patients can take part Commissions and funds NHS and social care research Provides academic training and development for researchers

4 Aims of NIHR CRN To develop England-wide infrastructure embedded within the NHS to support high quality research across all areas of health and clinical need funded by both commercial and non-commercial funders Ensure that patients and healthcare professionals from all parts of the country are able to participate in and benefit from clinical research Integrate health research and patient care Improve the quality, speed and coordination of clinical research by removing the barriers to research in the NHS Strengthen research collaboration with industry and ensure that the NHS can meet the health research needs of industry

5 The Clinical Research Network 6 TCRNs Stroke, Cancer, Diabetes, Mental Health, Medicines for Children, Dementias and neurodegenerative diseases CCRN 25 Comprehensive Local Research Networks PCRN 8 Primary Care Research Networks NIHR Clinical Research Network Coordinating Centre CRNCC

6 What does the NIHR CRN offer to Industry Access A single point of contact and entry for all services Access to NIHR CSP Access to dedicated and trained network staff Access to the NHS clinician and patient population Access to performance management resource

7 What does the NIHR CRN offer to Industry Support Protocol feasibility from KOL & commercial researchers Support with study start up & costing and contract negotiations Support to identify investigators and research sites Support with performance management of adopted studies Support with recruitment - Network badging of adopted trials to attract investigators & patients

8 What does practical support mean? We reduce the red-tape around setting up a study (Coordinated Systems for gaining NHS Permission) We enhance NHS resources by funding the additional people (e.g. research nurses) and facilities needed to support research on the ground We advise researchers on how to make their study work in the NHS, help them to identify suitable NHS sites, and recruit patients to take part in research studies Our motivation: to provide patients with opportunities to participate in research

9 CRN MedTech Studies by Type Study Type Commercial IIT Non commercial

10 Spread of activity across the CRN Network CCRN 122 MCRN 2 DRN 15 DenDRON 11 NCRN 11 PCRN 8 SRN 7 MHRN 0 TOTAL 176* *2 studies not yet assigned to a specific network n Med Tech studies

11 CRN Portfolio of Studies Commercial Non-Commercial Industry funded and sponsored Industry funded, Academic/NHS sponsored Grant funded and academic /NHS sponsored

12 Routes into Portfolio Apply via IRAS PORTFOLIO ELIGIBILITY ASSESSMENT Apply direct to Topic Network

13 Eligibility 1. A genuine and testable hypothesis/ valid research question with a possible future benefit for patients as its objective? 2. A statistically valid trial design 3. Evidence of adequate protocol review

14 Eligibility 4. Does the NIHR CRN CC network infrastructure have the current capacity to deliver the trial data reliably and on time? a. Are there conflicting studies within the current Portfolio? b. Are there sufficient patient numbers? c. Is there sufficient investigator interest?

15 Working with the CRN- what do you need? Early feedback on a draft protocol Site Intelligence where is the best place to do the study? Site Identification-finds interested investigators with the capability, capacity and facilities to do the study

16 Tools to support MedTech Studies MedTech costing template Model Clinical Investigation Agreement (mcia) Study milestone schedule Established Escalation pathways for rapid troubleshooting RAG reports to monitor monthly patient accrual to goal

17 MedTech Route map

18 More Information.. ustry ustry/medtech_route_map/index.htm ustry/networks/costing

19 Thank you