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:  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:  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 Immunology & inflammationPublic health research CardiovascularGastrointestinal Clinical GeneticsHepatology Ear, Nose and Throat (ENT)Reproductive Health & Childbirth Infectious Diseases and MicrobiologyDermatology Injuries & AccidentsHealth Services Research Metabolic & Endocrine (not Diabetes) Anaesthetics Musculoskeletal Critical Care Nervous System Disorders Surgery OphthalmologyRespiratory Oral and Dental Age & Ageing Non-malignant HaematologyUrogenital 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 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 studies 23 Multicentre studies 17 Single centre studies 6 Emergency Medicine 7 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 Critical Care 6 Observational or non- intervention3 RCT4 Observational or non- intervention2 RCT8 Observational or non- intervention5 RCT1

UK Clinical Research Network (UKCRN) Total studies 23 Multicentre studies 17 Single centre studies 6 Emergency Medicine 7 Critical Care 10 Critical Care 6 Observational or non- intervention3 RCT4 Observational or non- intervention2 RCT8 Observational or non- intervention5 RCT1

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 studies 23 Multicentre studies 17 Single centre studies 6 Emergency Medicine 7 Critical Care 10 Critical Care 6 Observational or non- intervention3 RCT4 Observational or non- intervention2 RCT8 Observational or non- intervention5 RCT1

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?