Understanding the Role of the NIHR: An Introduction to the Clinical - PowerPoint PPT Presentation

Understanding the Role of the NIHR: An Introduction to the Clinical Research Network: Julie Mugarza Karen Lomax Thomas Rice

The National Institute of Health Research (NIHR) • Established by the Department of Health and Social Care to improve the nation’s health and wealth through research • Plays a key role in the Government’s strategy for economic growth, attracting investment by the life-sciences industries • The NIHR is the research arm of the NHS

Where we fit in…

CRN Structure

CRN NWC Geography Aintree University Hospital NHS Foundation Trust NHS Blackburn and Darwen CCG Alder Hey Children’s NHS Foundation Trust NHS Blackpool CCG Blackpool Teaching Hospitals NHS Foundation Trust NHS Chorley & South Ribble CCG Cheshire and Wirral Partnership NHS Foundation Trust NHS East Lancashire CCG Countess of Chester Hospital NHS Foundation Trust NHS Fylde & Wyre CCG South Cumbria The Clatterbridge Cancer Centre NHS Foundation Trust NHS Greater Preston CCG Lancashire Care NHS Foundation Trust NHS Halton CCG Lancashire Teaching Hospitals NHS Foundation Trust NHS Knowsley CCG Liverpool Heart and Chest Hospital NHS Foundation Trust NHS Morecambe Bay CCG Liverpool Women’s NHS Foundation Trust Lancashire NHS Liverpool CCG Mersey Care NHS Foundation Trust NHS South Cheshire CCG The Mid Cheshire Hospitals NHS Foundation Trust NHS South Sefton CCG North West Boroughs NHS Foundation Trust NHS Southport & Formby CCG Royal Liverpool & Broadgreen University NHS Trust NHS St Helens CCG Merseyside Southport & Ormskirk Hospitals NHS Trust NHS Vale Royal CCG St Helens & Knowsley Teaching Hospitals NHS Trust NHS Warrington CCG The Walton Centre NHS Foundation Trust NHS West Cheshire CCG Cheshire University Hospitals of Morecambe Bay NHS Foundation Trust NHS West Lancashire CCG Warrington and Halton Hospitals NHS Foundation Trust NHS Wirral CCG Wirral Community NHS Trust Wirral University Teaching Hospital NHS Foundation Trust 5

High Level Objectives • Increase the number of participants recruited into NIHR CRN Portfolio studies • Increase the proportion of studies in the NIHR CRN Portfolio delivering to recruitment time and target • Increase the number of commercial contract studies delivered through the NIHR CRN

High Level Objectives • Reduce the time taken for eligible studies to achieve set up in the NHS • Reduce the time taken to recruit first participant into NIHR CRN Portfolio studies • Increase NHS participation in NIHR CRN Portfolio studies • Increase the number of participants recruited into Dementias and Neurodegeneration (DeNDRoN) studies on the NIHR CRN Portfolio

CRN Support The CRN supports studies by: • Funding research support posts in the NHS and providing national training – ensuring researchers have access to experienced frontline staff • Funding to meet the costs of using facilities, such as scanners and X-ray • Helping identify and recruit patients, enabling researchers to complete their study on time and on target • Support academics with linking them to regional and national leads within the specialty areas

Task Force • Flexible workforce of Research Nurses, Research Facilitators and Data Administrators to provide complementary support to existing study teams • Placements are temporary and time limited – to cover capacity issues to help in the local delivery of a study • Application for support via Task Force Request form – submitted to Research Matron • Allocation of staff determined at weekly RDM/ Matron meetings

NWC Performance

NWC Performance

What is the Study Support Service A high quality, consistent research delivery function • The NIHR CRN facilitates the development, set-up and delivery of clinical research studies in the NHS • A wide range of guidance and procedures to support research delivery in the NHS has been developed • The Study Support Service has been introduced to ensure greater consistency to this offering • Regardless of the topic of research, or location, the researcher should receive the same level of support for Portfolio Studies. Not a new service but streamlined and standardised what was already being done (one CRN approach)

Study Support Service https://www.youtube.com/embed/QWv56Y9rXyE?rel=0&autoplay=1

Study Support Service

Study Support Service

What is the NIHR Portfolio? The NIHR CRN Portfolio is a database of clinical research studies being undertaken in the NHS that are supported by the NIHR Clinical Research Network (CRN) in England. It is often referred to simply as “The Portfolio”. Studies have to meet specific eligibility criteria to become Portfolio Studies.

Portfolio Eligibility • For a study to be eligible for adoption on to the NIHR Portfolio it needs to meet the following criteria: – Meet the definition of a Research Study – Funded by an NIHR Partner – The Grant award must have been obtained as a result of open competition across England with high quality peer review – The research must be of clear value to the NHS and ensuring the study takes account of the priorities, needs and realities of the NHS

How do I get my study on the NIHR Portfolio?

How do I get my study on the NIHR Portfolio?

Expansion of CRN support into non-NHS settings

Expansion of CRN support into non-NHS settings

Expansion of CRN support into non-NHS settings

Expansion of CRN support into non-NHS settings

AcoRD Guidance • Department of Health document first published in May 2012 superseding ARCO (Attributing revenue costs of externally funded non-commercial research in the NHS) • Provides a framework to enable identification, attribution and recovery of various costs associated with research in the NHS • Activities are attributed based upon the primary purpose of conducting the activity (previous guidance focused on who was undertaking the activity and where it took place)

Basic Principles • Research Costs – the costs of the R&D itself that end when the research ends. They relate to activities that are being undertaken to answer the research question. • NHS Treatment Costs – the patient care costs, which would continue to be incurred if the patient care service in question continued to be provided after the R&D study had stopped. • NHS Support Costs – the additional patient care costs associated with the research, which would end once the R&D study in question had stopped, even if the patient care involved continued to be provided.

Non-Commercial Studies • Research (Part A) Costs – are met by grant funders through the award of a research grant. • Research (Part B) Costs – are met by grant funders through the award of a research grant unless the funders are an AMRC member. • NHS Treatment Costs – met through the normal commissioning process unless identified as an Excess Treatment Cost . • NHS Support Costs – met from the R&D budget by the Health Departments of the United Kingdom.

The Attribution Process

SoECAT • Schedule of Events Cost Attribution Template • Requires validation by a named AcoRD expert at the pre-application stage

Standard of Care • Enter current routine care activities for relevant participant group

General Activities • Enter general activities associated with site set-up, trial conduct and site-close-down • Attribute activities under AcoRD guidance

Per-Participant Activities • Enter per-participant activities (separate tabs for each arm of study) • Attribute activities under AcoRD guidance

Cost Calculations • Costs calculated per-participant and summed for all participants • Per-participant attribution values (Research, Support, Treatment, Excess Treatment etc.) added to Central Portfolio Management System (CPMS) post-award • From 1 st October 2018 the process for funding of Excess Treatment Costs (ETCs) has changed https://www.youtube.com/embed/m2VOpyFgDJ8?rel=0&autoplay=1

Contacts Study Support Service study-support.crnnwcoast@nihr.ac.uk Industry Team industry.cnrnwcoast@nihr.ac.uk Primary Care Team primarycare.crnnwcoast@nihr.ac.uk

Questions