The Role of Clinical Trials Units
Helen Hill
Senior Regional Advisor Clinical Trials
hhill@liv.ac.uk
www.ctrc.org.uk
Clinical Trial + Units
Specialist units to design, conduct, analyse and publish clinical
trials and other well-designed studies.
Expert statistical, epidemiological and other methodological
advice
Co-ordination of trials involving investigational medicinal
products (CTIMP) within the UK Medicines for Human Use CT
Regulations resulting from the EU Directive for Clinical Trials.
30 Fully Registered Clinical Trial Units
+16 provisional or pending
Registration approved by an
international review committee
capability to centrally coordinate
multi-centre clinical trials portfolio
design
development
recruitment
data management
publicity
analysis
Robust systems to ensure conduct and delivery of clinical trials to the highest quality standards.
North West Clinical Trials Collaborative
Manchester Academic Health Science Centre MAHSC /
Christies Trials Co-ordinating Unit
Liverpool Trials Collaborative
Liverpool Cancer Trials Unit /Liverpool Clinical Trials Research Centre
North West Clinical Trial
Each CTU has expertise in different disease areas or different
trial designs
http://www.ukcrc-ctu.org.uk/search/custom.asp?id=468
North West Surgical Trials Centre
Developing new surgical trials and methodology
Educating new surgical researchers
Increasing surgical trial recruitment in NW England
Developing reliable data on surgical trials
Developing a NW surgical trainee collaborative
Contact Jenna Paglia jpaglia@liv.ac.uk
North West Surgical Trials Centre Launch Event
Friday 20th September 2013: Newton-le-Willows
10.00am – 4.30pm
CTU Provide support at each stage
NIHR Clinical Trial Tool Kit
(MRC DOH)
http://www.ct-toolkit.ac.uk/routemap/trial-planning-and-design
Development of new trials
 Research question, methodology and design
 Statistical Analysis
 Costings (CTRC & whole trial)
 Direct Research costs (Grant)
 NHS Treatment costs (funded by the Trust even cost of IMP)
 NHS Support Costs includes consent ! (NIHR/CLRN)
 Grant applications –submit early
 Feasibility very important to funders is it realistic !
 Patient public Involvement
Clinical Trial Set up
 Trial Supplies (IMP Investigational Medicinal Product) **
 Case report form development (infermed MACRO)
 Web-based & automated telephone randomisation system
development
 Trial Management
 Establishment & constitution of Independent Data IDSMC & TSC
 Approvals – ethical, regulatory & institutional
 Essential documents centrally
 Multi centre site coordination and initiation (international)
• Patient Identification Centres or follow up sites **
Clinical Trial Conduct
 Monitoring (Patient Safety, rights and confidentiality, data reliability)
 Consent ‘innovative’ approaches prospective or emergency deferred
consent
 Pharmacovigilance safety monitoring/ reporting **
 Exclude anticipated events limit reporting proportionate to the risk
 Serious and Non-serious adverse event reporting
 Accrual
Regulatory and governance issues
 MHRA Good Clinical Practice Guide
 Risk Assessment –proportionate
 EMeA guidance pharmacokinetics,
paediatrics and bacteria
• ICH Guidelines on Good Clinical Practice
• EU directive on Clinical Trials (2001/20/EC)
• Research Governance Framework for Health and Social Care
• Medicines for Human Use (clinical Trials) Regulations
• Human Tissue Act (UK)
• Mental Capacity Act (UK)
• EU Directive on Good Clinical Practice (2005/28/EC)
Risk Proportionate Approach
 Association of Medical Science reported the trial regulations were a barrier
to research
 Risk to patient safety, data reliability and rights and confidentiality
 MHRA Risk Proportionate Approach reduces regulatory requirements
 Daily Temperature monitoring
 Drug accountability records
 Pharmacovigilance reporting
 Substantial amendments
 Inspections
 Low to high risk Type A Type B Type C
Wider remit
 Systematic Reviews
 Health Economics
 Clinical Research Networks
 Negotiations with pharmaceutical industry
NIHR Clinical Trials Units Support Funding
 Birmingham Clinical Trials Unit -University of Birmingham
 Bristol Randomised Trials Collaboration - University of Bristol
 Liverpool Clinical Trials Research Centre - University of Liverpool
 Imperial Clinical Trials Unit - Imperial College London
 Kings Clinical Trials Unit - Kings College London
 Leeds Clinical Trials Research Unit -University of Leeds
 Leicester Clinical Trials Unit - University of Leicester
 London School of Hygiene & Tropical Medicine Clinical Trials Unit
 National Perinatal Epidemiology Unit (NPEU) Clinical Trials Unit -University of Oxford
 Newcastle Clinical Trials Unit - Newcastle University
 Norwich Clinical Research & Trials Unit - Norfolk and Norwich University Hospital
 Nottingham Clinical Trials Unit -University of Nottingham
 Oxford University Trials - University of Oxford
 Peninsula Clinical Trials Unit - Peninsula Medical School
 Pragmatic Clinical Trials Unit - Barts and The London School of Medicine and Dentistry
 PRIMENT Clinical Trials Unit - University College London
 Sheffield Clinical Trials Research Unit - University of Sheffield
 University of Southampton Clinical Trials Unit University of Southampton
 Warwick Clinical Trials Unit - University of Warwick
 York Trials Unit - University of York
When to involve a CTU
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As early as possible!
CTIMP (Clinical Trial Investigating a Medicinal Product)
Multi-centre RCT (CTIMP/ nonCTIMP)
Multi-centre pilot/ feasibility
Methodology
High risk
Proposed funder – e.g. NIHR HTA, EME
Cost of the service applies if funded
CTU ↑
Commissioning &
funding research
Streamlined and simple knowledge
management systems
www.nihr.ac.uk
North West
Research Design Service (RDS) NIHR
Develop and design research proposals for funding competitions
NIHR Research for Patient Benefit Programme and Programme Grants for Applied Research)
Liverpool, Lancaster and Manchester Universities
http://www.rds-nw.nihr.ac.uk/research-design/
free of charge to anyone intending to apply for open competition
peer review funding and who is an NHS researcher or working in
partnership with the NHS
 Research Design
 Funding
 Patient Public Involvement
RESOURCES FOR PUBLIC INVOLVEMENT IN THE RESEARCH PROCESS
http://www.rds-nw.nihr.ac.uk/resources/PPI/How_to_guide_versionv3.pdf
MRC Hubs for Trials Methodology Research
Regional centres of excellence clinical trial methodology.
MAST Methodology Advisory Service for Trials
non-standard methodology
enquiries@methodologyhubs.mrc.ac.uk
North West Hub Liverpool Lancaster and Bangor
to improve patient care by improving the validity and relevance of the
healthcare evidence base
3 themes
1.Early phase trial design and analysis PK/PD
2. Later phase trial design and analysis www.COMETinitiative.org
3. Patient perspectives - RECRUIT
Funding extended for 5 years – today…
Hub educational opportunities
 Online MSc Clinical Research University of Liverpool
ethical, legal and regulatory ,Good Clinical Practice, the
design and conduct of the clinical protocol, biostatistics, data
management, product development and health economics.
 MSc Medical Statistics, Lancaster University
 Training workshops, research days
www.liv.ac.uk/nwhtmr
Thank you
Helen Hill
Senior Regional Advisor – Clinical Trials/Research Design Service
hhill@liv.ac.uk
Liverpool Cancer Trials Unit
 Pancreatic cancer
 Head and neck cancers
 Lung cancer
 Haematology
 Palliative care cancer work
 Urological cancers
 Pharmacogenetics
and non-cancer trials
Clinical Trials Research Centre
(UOL based at Alder Hey Children’s NHS FT)
 Medicines for Children (except cancer)
 Pharmacogenetics
 Infection
 Neurology
 Reproductive and child health
 Vision Science
and more
Manchester Academic Health Science
Centre Trials Co-ordination Unit
Christies Trials Co-ordinating Unit
 Cancer
 Mental Health
 Metabolic and Endocrine
and more
NIHR Support – and resources
Topic Specific Research Networks
Diabetes
Medicines
for
Mental
Health
National
Cancer
Children
Comprehensive
Research Network
Primary
Care
Stroke
Dementia and
Neurodegenerative
Networks Support Researchers
 Adopted by NIHR within Clinical Study Group Remit
 Funding research nurses at Trust site (non study)
 Recruitment
 Data collection
 Follow up of patients activity based funding

Site approvals NRES R&D MHRA