Access to drugs, Reducing bottlenecks
Matt Cooper
Business Development & Marketing Director NIHR Clinical Research [email protected]
Supporting the life-sciences industry in UK clinical research delivery
Build Upon Our Past to Ensure Future Success
The CRN is a flagship of achievement for the National Institute for Health Research and Department of Health
Recruiting over 3 million patients into clinical research studies over the last 5 years
Nearly 35,000 patients into commercial clinical trials in the previous year
UK landscape
• Political commitment to supporting life-sciences industry• Health & Social Care Act 2012 / NHS Constitution 2013
– Embed clinical research in all aspects of care
One national network
• Research active engaged clinicians across all 30 therapy areas
• Detailed understanding of care pathways
• 15 Local Clinical Research Networks (LCRNs)
• Research ready workforce• Links with rest of UK
Business Development
Vision: The UK is the number one location in Europe, and in the top 5 worldwide, in which to conduct clinical research.
European CompetitionData source: http://clinicaltrials.gov/
1. Germany 686
2. United Kingdom 675
3. France 501
4. Spain 465
5. Belgium 365
(All Phase II, III, IV studies received from 01/04/2014 to 31/03/2015 funded by Industry)Retrieved online on 29 April 2015
Speed: UK vs the worldData source: Global CRO 1
Median time (weeks) for complex study set up. From final protocol AND global model ICF available, to 1st site initiated in a given country
Quality
National Network of Clinical Experts
• A research-ready workforce
• Embedded in the NHS to support investigators
• Thousands of healthcare professionals undertake our on-line GCP training each year
• Free to staff working on NIHR CRN clinical trials
• Supported by MHRA
FEASIBILITY
Manage and deliver:• Early Feedback• Site Intelligence
• Site Identification
COMMERCIAL COSTING
TEMPLATES
• Support use• Manage templates
• Trust, Primary Care & Device versions
NIHR COORDINATED SYSTEM FOR GAINING NHS PERMISSION
• Support use
MODEL AGREEMENTS
• Support use
STUDY MANAGEMENT
• Collect & collate data
• Performance manage study
Feasibility Set-up Delivery
Support My Study service
PerformanceNo studies up
No recruits up
NHS engagement up
Set up time down
Delivery
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UK competes on expertise, set up & delivery
Challenge is price and adoption of innovation
Excellent delivery in DMD studies
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Supporting innovation - study design & delivery
Strategic Industry Alliances
• Academic partnerships between CRN and individual companies to design investigator-led, academically-sponsored studies
• Aim: to optimise early phase testing of new therapies not part of the company’s main R&D programme
• Pilot in oncology
Building Capacity in Partnership with Charities
• Address capacity issue - impacting on the opportunity for life sciences companies to place more studies in some rare disorders in the UK and therefore reducing opportunity for patients to access potentially life-changing treatments.
• July - National Workshop on DMD Clinical Trial Capacity
• William van't Hoff & Katie Bushby – Newcastle Proposal
Proposal
• Charities to consider pump priming a post(s) to facilitate uptake of one or several studies
• Contract with site allows the charity to recover the costs of the new post over time from commercial revenue generated by delivery of the studies.
• The extent of ‘pump priming’ would depend on the study and anticipated revenue.
• It does not involve any specific contract between charity and a commercial sponsor
Summary
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1) UK is open for business and conducts world leading science
2) Quality & delivery at pace is key
3) Innovation is part of a clinical research culture embedded in the NHS