Transcript Slide 1

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 activitybased 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 Bonner
Dr Jonathan Coles
Prof Charles Hinds
Dr Danny McAuley
Dr Jonathan Thompson
Dr Duncan Young
Prof Julian Bion
Prof Timothy Evans
Prof Richard Griffiths
Dr Suzanne Mason
Dr David Higgins
Dr Mike Grocott
Dr Gavin Perkins
Co-opted:
Kathy Rowan (ICNARC)
Fiona Lecky (TARN)
13 of 26 CLRNs
2 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 nonautomatic 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 studies
23
Multicentre studies
17
Emergency Medicine
7
Single centre studies
6
Critical Care
10
Critical Care
6
UK Clinical Research Network (UKCRN)
Total studies
23
Multicentre studies
17
Single centre studies
6
Emergency Medicine
7
Critical Care
10
Observational or nonintervention
3
Observational or nonintervention
2
Observational or nonintervention
5
RCT
RCT
RCT
4
Critical Care
6
8
UK Clinical Research Network (UKCRN)
1
Total studies
23
Multicentre studies
17
Single centre studies
6
Emergency Medicine
7
Critical Care
10
Observational or nonintervention
3
Observational or nonintervention
2
Observational or nonintervention
5
RCT
RCT
RCT
4
Critical Care
6
8
UK Clinical Research Network (UKCRN)
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 preoperative 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)
•
[email protected]
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 (BALTIprevent)
•
[email protected]
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 studies
23
Multicentre studies
17
Single centre studies
6
Emergency Medicine
7
Critical Care
10
Observational or nonintervention
3
Observational or nonintervention
2
Observational or nonintervention
5
RCT
RCT
RCT
4
Critical Care
6
8
UK Clinical Research Network (UKCRN)
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
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?
UK Clinical Research Network (UKCRN)