Outline

1. How research networks can support study set-up and delivery Dr Lesley Hall Non-Commercial Portfolio Manager26 September 2011

2. Outline • Provide some background to the types of infrastructure support provided by National Institute for Health Research (NIHR) to allow high-quality research to take place in the NHS • Describe how DeNDRoN fits into this structure and how we support: • Non-commercial studies that are eligible for NIHR Clinical Research Network (CRN) support and inclusion in the NIHR CRN Portfolio • Industry studies that apply for adoption to the NIHR CRN Portfolio

3. NIHR Infrastructure • NIHR provides infrastructure and support in various ways – Some examples are: • Biomedical Research Centres and Units (BRUs/BRCs) • Experimental Medicine Facilities • Collaborations for Leadership in Applied Health Research and Care (CLAHRCs) • Patient Safety & Service Quality Research Centres (PSSQs) • Research Centres AND • Clinical Research Networks (CRNs)

4. NIHR Clinical Research Network (CRN) • The NIHR CRN includes networks which co-ordinate studies for specific conditions – often referred to as Topic Clinical Research Networks (TCRNs): • Cancer • Dementias and Neurodegenerative Diseases • Diabetes • Medicines for Children • Mental Health • Stroke • Also a Comprehensive Research Network to encourage research in all areas other than the specific conditions above • A Primary Care Research Network focusing on health areas for which primary care has particular responsibility

5. NIHR DeNDRoN • NIHR DeNDRoN (Dementias & Neurodegenerative DiseasesResearch Network) is a managed network working across the following areas: • Dementias • Parkinson’s Disease • Motor Neurone Disease • Huntington’s Disease • Other neurodegenerative diseases • We offer effective support through an experienced and flexible workforce of dedicated and specialist staff • Provide access to a broad geography of NHS patient populations

6. DeNDRoN - Supporting research • At a national level DeNDRoN has a Co-ordinating Centre that directs the support required for studies: • Through 7 DeNDRoN Local Research Networks (LRNs) in England: • Working with other parts of the Clinical Research Network (eg, other topic specific networks, PCRN or the Comprehensive CRN) to co-ordinate support for studies • Linking with relevant research networks in Scotland, Wales and Northern Ireland

7. DeNDRoN support throughout the life cycle of a non-commercial research study Pre-funding Post-funding

8. Development of non-commercial studies • Support for development is directed at DeNDRoN co-ordinating centre by the Portfolio Development Manager through specific output-focused activities: • Clinical Studies Groups • Task Forces • Writing Groups • Patient and Public Involvement (PPI) is supported by a dedicated PPI Co-ordinator providing expert advice in developing a PPI plan to support applications

9. Set-up and DeliveryNon-commercial studies • Once funded each non-commercial study eligible for NIHR CRN support is assigned a Lead Network to take responsibility for facilitating the set-up of studies • The role of the LNS is to: • work with the Chief Investigator to map the service support required across the CRN • Provide access to our experienced workforce within the LRNs and other parts of the CRN where necessary • Offer expertise with regard to recruitment • Help to identify additional sites where required • Help resolve problems to aid the speedy set-up of studies so that sites are ready to recruit as soon as NHS Permissions are in place

10. Set-up and delivery – industry studies DeNDRoN facilitates the set-up and conduct of clinical research in collaboration with pharmaceutical, technology and clinical research organisations by: • Performing study and site level feasibility • Facilitating the adoption of studies to the NIHR CRN portfolio • Identifying additional sites • Providing access to a workforce experienced in complex, interventional and observational clinical research • Ensure studies are delivered on time and to the recruitment targets set

11. DeNDRoN Support ‘on the ground’ • Our LRN managers can discuss the logistics of doing studies and are proactive in highlighting potential study challenges as well as suggesting possible solutions • We can help with identifying and screening participants • Staff experienced in working with our specific patient groups can discuss studies and take consent • We can provide research nurses/Clinical Study Officers to do selected activities which do not require a doctor • We can support investigators with NHS Permissions by contributing to Site Specific Information (SSI) forms • We can help with publicising studies • We can train research staff to work on Portfolio studies • We can help with recruitment of research staff for new sites

12. Useful DeNDRoN Contacts Portfolio Development Manager - Denise Wilson denise.wilson@dendron.org.uk 0191 248 1347 PPI Co-ordinator - Terry McGrath terry.mcgrath@dendron.org.uk - 020 7242 3311  Non-Commercial Portfolio Manager – Lesley Hall Lesley.hall@dendron.org.uk - 0191 248 1328 Industry Manager – Judith Hedley (interim) industry@dendron.org.uk – 0191 248 1318 Management Information Systems Analyst – Kris Beicher Kris.beicher@dendron.org.uk – 0191 248 1346 For contact details for all Local Research Networks see: DeNDRoN website: http://www.dendron.org.uk/index.html