UK Clinical Research Network (UKCRN) Where to in Scotland for Critical Care Research…..a research...

UK Clinical Research Network (UKCRN)

Where to in Scotland for Critical Care Research…..a research network?

Tim Walsh

Chair NIHR CCRN Critical Care Specialty Group

Chair, SCCTG Executive Group


The Operating Framework for the NHS in England 2009/10

“18. ……NHS trusts and NHS foundation trusts have a statutory duty to support education and training. All providers of NHS care will need to increase their participation in research. The national ambition is to double the number of patients taking part in clinical trials and other well-designed research studies within five years. SHAs are expected to ensure that NHS trusts work with the National Institute for Health Research Comprehensive Clinical Research Network locally to contribute to this progressive increase.”


UK Clinical Research Network

UKCRN Launched in February 2005 as part of UKCRC’s research

infrastructure workstream Coordinating centre in Leeds and London National Cancer Research Network (NCRN): already in

existence - established in 2001 Mental Health Research Network (MHRN): already in

existence – established 2004 Another four TCRNs created from scratch


NIHR CLRN Funding

Stage 1: 2007 - 2008 Establishing the NIHR CLRNs Fixed allocation to support the management team Per capita of population served allocation for

research management staff Per capita of population served allocation for

research infrastructure


NIHR CLRN Funding

Stage 2: 2008 - 2009 All CLRNs continue to receive the fixed and per

capita allocations as in 2007/08 In addition each CLRN will also receive activity-

based funding - a flexible allocation calculated on the basis of past activity for that CLRN

Activity-based funding: recalculated annually Funding follows activity!


Specialty Group Specialty Group

Immunology & inflammation Public health research

Cardiovascular Gastrointestinal

Clinical Genetics Hepatology

Ear, Nose and Throat (ENT) Reproductive Health & Childbirth

Infectious Diseases and Microbiology Dermatology

Injuries & Accidents Health Services Research

Metabolic & Endocrine (not Diabetes) Anaesthetics

Musculoskeletal Critical Care

Nervous System Disorders Surgery

Ophthalmology Respiratory

Oral and Dental Age & Ageing

Non-malignant Haematology Urogenital

Renal Paediatrics


Specialty Groups

Groups based on the UKCRC Health Research Classification System

Provide expertise to the UKCRN and NIHR CCRN in twenty-six specific topics not covered by the TCRNs

Secretariat provided by the UKCRN Coordinating Centre – Coordinator and Clerical Officer


Specialty Group Remit

Portfolio Development vs Portfolio Delivery Specialty Groups funded to improve portfolio

delivery rather than to drive portfolio of research in a specific topic area

BUT potential to interact with “portfolio development groups” Eg ICNARC, ICS, UK Trial forum etc


Prof Tim Walsh (Chair)Dr Jonathan Benger (Vice Chair)Dr Stephen BonnerDr Jonathan ColesProf Charles HindsDr Danny McAuleyDr Jonathan ThompsonDr Duncan Young Prof Julian BionProf Timothy EvansProf Richard GriffithsDr Suzanne MasonDr David HigginsDr Mike GrocottDr Gavin Perkins

Co-opted: Kathy Rowan (ICNARC)Fiona Lecky (TARN)13 of 26 CLRNs2 of 3 devolved nations


Eligibility for NIHR portfolio

Basic requirements – funded in open national competition and with independent peer review

Automatic – NIHR partners e.g. MRC, DH, major charities

High priority with adoption process – industry sponsored studies

Medium priority with adoption process – e.g. EU or internationally funded studies, industry collaborative studies


Non-automatic funders

Review by adoption panel process Review by experts in field (from specialty groups)

for Suitability/Practicalities Relevance In context of current portfolio

Applies to commercial and non-commercial non-automatic studies

(No commercial studies yet on the critical care/EM portfolio)


Eligibility of funders

Grey areas still exist Funding bodies have to register for eligibility Intensive Care Society, NIAA and other relevant

funders still awaiting decisions


Portfolio

Studies covering critical care and emergency medicine (mainly)

Observational and interventional studies Single centre and multicentre studies

CLRNs that have nominated critical care as a local priority should support portfolio studies

Nature of support not clearly defined Accrual to these studies generates resource to local CLRN


Overview of studies

23 active on the portfolio 2 studies registered on the portfolio, but in set up 4 studies in set up, not yet on portfolio 2 studies completed/closed

TracMan (909 patients; reported to investigators/Brussels)

SIGNET (502 patients; reporting to investigators October/ESICM Vienna)


Total studies23

Multicentre studies17

Single centre studies6

Emergency Medicine7

Critical Care10

Critical Care6


Total studies23



Emergency Medicine7

Critical Care10

Critical Care6

Observational or non-intervention 3

RCT 4


RCT 8


RCT 1


RCTs in Critical Care

1. High frequency oscillatory ventilation versus conventional ventilation for ARDS (OSCAR)

2. The Beta 2 agonist lung injury trial (BALTI II)

3. The utility of cardiopulmonary exercise testing for pre-operative risk stratification to guide perioperative care and reduce postoperative morbidity

4. Beta agonist lung injury prevention trial (BALTI-prevent)

5. Impact of an aerobic exercise rehabilitation programme on fitness and QOL in ICU survivors


RCTs in Critical Care

6. A feasibility randomised trial comparing restrictive versus liberal blood transfusion strategies in patients requiring four or more days of mechanical ventilation (RELIEVE)

7. Randomised evaluation of surgery with craniectomy for uncontrollable elevation of intracranial pressure

8. Optimisation of perioperative cardiovascular management to improve surgical outcomes (OPTIMISE)


• The Beta 2 agonist lung injury trial (BALTI II)

• [email protected]


BALTI II• A multicentre pragmatic randomised double-blind placebo-controlled clinical trial• Patients fulfilling the American-European Consensus Conference Definition of ARDS• Randomised 1:1 to receive an IV infusion either of salbutamol or placebo for a maximum of seven days• Data recorded by participating ICUs until hospital discharge and all surviving patients followed up by post at six and twelve months post randomisation • Primary outcome is mortality at 28 days after randomisation• Secondary outcomes are a range of mortality, ventilation, QOL, and economic outcomes• 1,334 patients from about fifty ICUs in the UK


• Beta agonist lung injury prevention trial (BALTI-prevent)

• [email protected]


BALTI-prevent

Double blind RCT Patients undergoing oesophagectomy Inhaled salmeterol versus placebo during

perioperative period Follow up for 3 months 216 patients Primary outcome reduction in acute lung injury


OSCAR multicentre, randomised controlled trial (RCT) comparing

conventional positive pressure ventilation with high frequency oscillatory ventilation (HFOV) for adults with acute respiratory distress syndrome (ARDS).

Treatment A: Conventional positive pressure ventilation, or Treatment B: High frequency oscillatory ventilation.

The primary outcome is mortality at 30 days after randomisation

Secondary outcomes at 6, 12 months (include QOL, functional measures)

1006 patients in 12 centres


Total studies23



Emergency Medicine7

Critical Care10

Critical Care6


RCT 4


RCT 8


RCT 1


Non-interventional/observational studies

Genetic and epigenetic modulators of gene expression in sepsis as part of the UK Genomic Advances in Sepsis (GAinS) study Charles Hinds/Julian Knight

A study of the long term economic impact of critical illness and its association with health related QoL in patients discharged from Intensive Care Units (iCAN-UK) Steve Brett/John Griffiths


Other Pipeline Projects

Risk Adjustment in Neuro Critical Care (RAIN) RCT of early enteral with parenteral nutrition

(CALORIES) RCT of Early Goal Directed Therapy for Sepsis

(PROMISE) RCT of Therapeutic hypothermia in head injured

patients (EUROTHERM)


Scotland

Funding structure fundamentally different R&D departments Currently undergoing period of disembedding funding Academic Health Science Centres No Accrual funding/payments for portfolio studies

Network funding for Critical Care not committed Scotland considered a single entity in UK process


Scottish Solutions

Approach to the CSO

Building up momentum through individual Board R&D support (research nurses and coordinators)

Professional collaboration nationally Changing role for the SCCTG Recording National Accrual as a

quality/performance marker through the SCCTG/SICS


Any Ideas?

UK Clinical Research Network (UKCRN) Where to in Scotland for Critical Care Research…..a research...

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