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Peter Langhorne Professor of stroke care University of Glasgow
Building a portfolio of multicentre research studies: What we can learn from the Stroke Research Network? Peter Langhorne Professor of stroke care University of Glasgow Thanks to Matthew Walters, Claire McFarlane, Karen McBurnie, Liz Ronald
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Why Stroke Matters Burden of disease >110,000 strokes each year
>20,000 Transient Ischaemic Attacks (TIAs or ‘mini strokes’) At least 300,000 living with significant post-stroke disability (single largest cause of adult severe disability) Third most common cause of death 1 in 4 people affected are under 65 Costs £2.8 billion direct care costs £1.8 billion due to lost productivity and disability £2.4 billion informal care costs 2.6 million bed days per year
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UKCRC Funding Analysis 2006
Critical Risks UKCRC Funding Analysis 2006 14th Rank
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Why does clinical research face difficulties?
Regulatory Research ethics requirements Trial governance (R&D) requirements Management of research costs vs service costs Employment regulations (honorary staff, CRB) Environmental Pressures on NHS staff time Deficiencies in services Cultural Separation of service and research activities
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Our Team Gary Ford
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Our Vision ”To provide a world class infrastructure for stroke research that supports the delivery of high quality studies which improve the outcomes and quality of life of people with stroke and their carers”
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What we said in 2005 7
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Delivering Our Vision Managed infrastructure Managed portfolio
Managed industry relationship
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Managed Infrastructure
Essential role of SRN Coordinating Centre in delivering our vision Support and manage the Stroke Local Research Networks - accrual targets - use of resources - problem solving Develop the portfolio Coordinate and develop patient, carer and public involvement Integrate with the devolved nations Interface with Government and NHS Collaborate with international stroke research
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Managed Infrastructure
Essential role of Local Stroke Research Networks in delivering our vision Local clinical leadership alongside managerial support Work with local stroke services and clinical stroke networks Deploy staff / resources effectively and flexibly (Advise CLRNs on best use of resources) Provide local perspective on feasibility
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Managed Infrastructure
What we have established
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Managed Infrastructure
Enabling all stroke patients across England to participate in research 2009/10 2010/11
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Our Project Management approach
Managed Portfolio Our Project Management approach Many trials also have a prolonged follow-up period after enrolment ceases 13
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Achieving a balance - strand
Managed Portfolio Achieving a balance - strand 16 14 12 10 Primary Care r Translational Number e b 8 m Acute u N Rehabilitation 6 Prevention 4 2 2006 2007 2008 14
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Achieving a balance - study phase
Managed Portfolio Achieving a balance - study phase 18 16 14 12 Number Pilot 10 Phase I Phase II 8 Phase III 6 Phase IV 4 2 2006 2007 2008
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Risk management and action plans
Managed Portfolio Risk management and action plans Data collated monthly, rigorous validation - QA system for data accuracy, data completeness 98% Quarterly reports / traffic light analysis Inform resource allocation and adoption decisions 16
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Collaborative Study Development
Managed Portfolio Collaborative Study Development HTA Clinical Trials Programme Call 2 stroke applications funded: Getting out of the house: A multi-centre RCT of a rehabilitation aimed at improving quality of life through an increase in outdoor mobility A cluster RCT of an occupational therapy intervention for residents with stroke living in UK care-homes Arose from patient/carer topics in rehabilitation CSG and subsequent targetted workshops; PCPI commended by HTA
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Managed Industry Relationship
Increasing awareness Meetings – ABPI With device, trade associations, CROs Stroke conferences Joint stand at international conferences with NIHR Clinical Research Network Coordinating Centre Case histories European Stroke Trials Network Website
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Our Performance No. of sites Patient accrual 2006 --- 2008
Quarter 3 data are projected based upon an 88% complete dataset National Sentinel Audit reported No. of stroke patients in research studies 19
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Managed Industry Relationship
PERFORM – Impact of SRN
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SSRN Home Page
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Scottish Approach Chief Scientist’s Office (2006)
Linked to Clinical Research Facilities (CRFs) Devolved regionally into four areas Devolved budgets 4 3 1 2 Glasgow & South West Edinburgh & South East Tayside & East Grampian & North
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SSRN Participating Hospitals
North Scotland Aberdeen Royal Infirmary Raigmore East Scotland Ninewells Hospital Perth Royal Infirmary South-West Scotland Ayr Hospital Crosshouse Hospital Glasgow Royal Infirmary Hairmyres Hospital Lorn & Islands Monklands Hospital Stobhill General Hospital Southern General Hospital Western Infirmary Wishaw General Hospital South-East Scotland Borders General Hospital Dumfries & Galloway Royal Infirmary Edinburgh Royal Infirmary Queen Margaret Hospital St. John’s Hospital , West Lothian Stirling Royal Infirmary Victoria Hospital, Kircaldy, Fife Western General Hospital Edinburgh
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Progress by 2009 Initial objectives established in 2006 have now been met: Develop and appoint the post of Research Network Manager Establish regional research committee representation Identify potential research active centres * Agree a broad approach to the allocation of resources to research active centres Raise the profile of Scottish Stroke Research Network Survey current research activity * Develop a Broad Study Portfolio Develop bid for further funding ( )
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Scottish recruitment
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A few SSRN trials
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A few SSRN trials
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A few SSRN trials
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Challenges (2008-09) Substantial drop in recruitment at start of year
Appears to have been due to several factors: closure or suspension of high recruiting studies (e.g. PERFORM, VITATOPS ) imaging problems at some sites (e.g. CLOTS) very active recruitment in meant that some sites were occupied with follow-up of recruited patients delays in recording patient recruitment failure to “adopt” studies
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Challenges (2008-09) We therefore put in place a number of measures:
Support efforts to open new studies (e.g. AVERT, Glasgow Care Givers Study, Modified Rankin Study, CLOTS 3, INTERSTROKE) Attempts to resolve imaging delays Ensure all existing research activity is appropriately acknowledged (especially single-site studies) Encourage local trials By October 2008 recruitment had substantially improved
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STUDY ACCRUAL TARGET GROUPS
RCT NON RCT AIAS ATTEST ARUBA BARRIERS AND FACILITATORS Augmented Visual Feedback in Upper Limb Stroke Rehab PISCES Augmented Visual Feedback with Gait Training in Sub- Acute Stroke DNA LACUNAR AVERT EOL Biomechanics visualisation in AFO tuning for stroke INTERSTROKE CADISS LINCHPIN CLOTS-3 MILD STROKE STUDY 2 DARS Physical Activity After Stroke DIASS-4 (SRN014) Fatigue After Stroke ECG-AF POSH ENOS TELEMEDICINE GOTH POPSTA HAIST IAMSS IRIS IST-3 Music Therapy for Acute Stroke Patients PILOT PATCH RTEASE SOS STASH STITCH-II SWIFT CAST TARDIS SSRN Randomised Control Trials V Non Randomised Control Trials April March 2012 STUDY ACCRUAL TARGET GROUPS Subjects who DO COUNT towards primary target (RCT Non RCT 596) 1182 Plus subjects who DO NOT count towards primary target 233 SSRN Total accrual 1415
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Lessons (with hindsight)?
Need political support Get people on board Inclusive approach Need help with trial governance Need staff on the ground Need the right kind of studies
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Scottish Approach Chief Scientist’s Office
Linked to Clinical Research Facilities (CRFs) Devolved regionally into four areas Devolved budgets 4 3 1 2 Glasgow & South West Edinburgh & South East Tayside & East Grampian & North
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Lessons (with hindsight)?
Need political support Get people on board Inclusive approach Need help with trial governance Need staff on the ground Need the right kind of studies
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Achieving a balance - strand
Managed Portfolio Achieving a balance - strand 16 14 12 10 Primary Care r Translational Number e b 8 m Acute u N Rehabilitation 6 Prevention 4 2 2006 2007 2008 36
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Recruitment – Teaching hospitals
Average recruitment Own Ix = 35 per year Other Ix = 22 per year Teaching hospital
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Recruitment – District General Hospitals
Average recruitment Own Ix = 0 per year Other Ix = 8 per year Average No extra staff support Some extra support District General Hospital
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Lessons (with hindsight)?
Need political support Get people on board Inclusive approach Need right kind of staff trial governance recruiting participants Need the right kind of service Need the right kind of studies
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Lessons (with hindsight)?
Need political support Get people on board Inclusive approach Need right kind of staff trial governance recruiting participants Need the right kind of service Need the right kind of studies
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Acute Care Organisation Quality
Managed Infrastructure Supporting Service Infrastructure and Research Participation Total clinical stroke research studies Acute Care Organisation Quality Poor Good Excellent 3+ 3 22 26 2 5 21 6 1 7 32 6 32 79 1 We are collaborating with York Centre for Health Economics and Sentinel Audit team (Director Tony Rudd) to analyse 2008 Sentinel Audit and SRN accrual data
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Lessons (with hindsight)?
Need political support Get people on board Inclusive approach Need right kind of staff trial governance recruiting staff on the ground Need the right kind of service Need the right kind of studies
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Challenges (2008-09) We therefore put in place a number of measures:
Support efforts to open new studies (e.g. AVERT, Glasgow Care Givers Study, Modified Rankin Study, CLOT 3, INTERSTROKE) Attempts to resolve imaging delays Ensure all existing research activity is appropriately acknowledged (especially single-site studies) Encourage local trials By October 2008 recruitment had substantially improved
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Lessons (with hindsight)?
Need political support Get people on board Inclusive approach Need right kind of staff trial governance recruiting staff on the ground Need the right kind of service Need the right kind of studies
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National Stroke Research Index
Stroke citations per million population
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Thank you for your attention
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