Understanding the Role of the NIHR: An Introduction to the Clinical Research Network:

Julie MugarzaKaren LomaxThomas Rice

• 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

The National Institute ofHealth Research (NIHR)

Where we fit in…

CRN Structure

CRN NWC Geography

5

South Cumbria

Lancashire

Merseyside

Cheshire

Aintree University Hospital NHS Foundation TrustAlder Hey Children’s NHS Foundation TrustBlackpool Teaching Hospitals NHS Foundation TrustCheshire and Wirral Partnership NHS Foundation TrustCountess of Chester Hospital NHS Foundation TrustThe Clatterbridge Cancer Centre NHS Foundation TrustLancashire Care NHS Foundation TrustLancashire Teaching Hospitals NHS Foundation TrustLiverpool Heart and Chest Hospital NHS Foundation TrustLiverpool Women’s NHS Foundation TrustMersey Care NHS Foundation TrustThe Mid Cheshire Hospitals NHS Foundation TrustNorth West Boroughs NHS Foundation TrustRoyal Liverpool & Broadgreen University NHS TrustSouthport & Ormskirk Hospitals NHS TrustSt Helens & Knowsley Teaching Hospitals NHS TrustThe Walton Centre NHS Foundation TrustUniversity Hospitals of Morecambe Bay NHS Foundation TrustWarrington and Halton Hospitals NHS Foundation TrustWirral Community NHS TrustWirral University Teaching Hospital NHS Foundation Trust

NHS Blackburn and Darwen CCGNHS Blackpool CCGNHS Chorley & South Ribble CCGNHS East Lancashire CCGNHS Fylde & Wyre CCGNHS Greater Preston CCGNHS Halton CCGNHS Knowsley CCGNHS Morecambe Bay CCGNHS Liverpool CCGNHS South Cheshire CCGNHS South Sefton CCGNHS Southport & Formby CCGNHS St Helens CCGNHS Vale Royal CCGNHS Warrington CCGNHS West Cheshire CCGNHS West Lancashire CCGNHS Wirral CCG

• 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

High Level Objectives

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

CRN Support

• 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

Task Force

NWC Performance

NWC Performance

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)

What is the Study Support Service

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

Study Support Service

Study Support Service

Study Support Service

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.

What is the NIHR Portfolio?

• 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

Portfolio Eligibility

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 purposeof 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 1st October 2018 the process for funding of Excess Treatment Costs (ETCs) has changed

https://www.youtube.com/embed/m2VOpyFgDJ8?rel=0&autoplay=1

Study Support Servicestudy-support.crnnwcoast@nihr.ac.uk

Industry Teamindustry.cnrnwcoast@nihr.ac.uk

Primary Care Teamprimarycare.crnnwcoast@nihr.ac.uk

Contacts

Questions