UK Clinical Research Network (UKCRN) Where to in Scotland for Critical Care Research…..a research...
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Transcript of 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
UK Clinical Research Network (UKCRN)
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)
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
UK Clinical Research Network (UKCRN)
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
UK Clinical Research Network (UKCRN)
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!
UK Clinical Research Network (UKCRN)
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
UK Clinical Research Network (UKCRN)
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
UK Clinical Research Network (UKCRN)
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
UK Clinical Research Network (UKCRN)
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
UK Clinical Research Network (UKCRN)
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
UK Clinical Research Network (UKCRN)
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)
UK Clinical Research Network (UKCRN)
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
UK Clinical Research Network (UKCRN)
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
UK Clinical Research Network (UKCRN)
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)
UK Clinical Research Network (UKCRN)
Total studies23
Multicentre studies17
Single centre studies6
Emergency Medicine7
Critical Care10
Critical Care6
UK Clinical Research Network (UKCRN)
Total studies23
Multicentre studies17
Single centre studies6
Emergency Medicine7
Critical Care10
Critical Care6
Observational or non-intervention 3
RCT 4
Observational or non-intervention 2
RCT 8
Observational or non-intervention 5
RCT 1
UK Clinical Research Network (UKCRN)
Total studies23
Multicentre studies17
Single centre studies6
Emergency Medicine7
Critical Care10
Critical Care6
Observational or non-intervention 3
RCT 4
Observational or non-intervention 2
RCT 8
Observational or non-intervention 5
RCT 1
UK Clinical Research Network (UKCRN)
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
UK Clinical Research Network (UKCRN)
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)
UK Clinical Research Network (UKCRN)
• The Beta 2 agonist lung injury trial (BALTI II)
UK Clinical Research Network (UKCRN)
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
UK Clinical Research Network (UKCRN)
• Beta agonist lung injury prevention trial (BALTI-prevent)
UK Clinical Research Network (UKCRN)
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
UK Clinical Research Network (UKCRN)
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
UK Clinical Research Network (UKCRN)
Total studies23
Multicentre studies17
Single centre studies6
Emergency Medicine7
Critical Care10
Critical Care6
Observational or non-intervention 3
RCT 4
Observational or non-intervention 2
RCT 8
Observational or non-intervention 5
RCT 1
UK Clinical Research Network (UKCRN)
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
UK Clinical Research Network (UKCRN)
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)
UK Clinical Research Network (UKCRN)
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
UK Clinical Research Network (UKCRN)
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
UK Clinical Research Network (UKCRN)
Any Ideas?