the role of clinical trials units helen hill senior regional advisor clinical trials [email protected]
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The Role of Clinical Trials Units
Helen Hill
Senior Regional Advisor Clinical Trials
www.ctrc.org.uk
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.
Clinical Trial + Units
30 Fully Registered Clinical Trial Units+16 provisional or pending
Registration approved by an international review committeecapability 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 CollaborativeLiverpool 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 methodologyEducating new surgical researchersIncreasing surgical trial recruitment in NW EnglandDeveloping reliable data on surgical trialsDeveloping a NW surgical trainee collaborative
Contact Jenna Paglia [email protected] West Surgical Trials Centre Launch EventFriday 20th September 2013: Newton-le-Willows10.00am – 4.30pm
NIHR Clinical Trial Tool Kit (MRC DOH)http://www.ct-toolkit.ac.uk/routemap/trial-planning-and-design
CTU Provide support at each stage
Development of new trialsResearch question, methodology and designStatistical 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 earlyFeasibility 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 developmentTrial Management
Establishment & constitution of Independent Data IDSMC & TSCApprovals – 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 riskSerious and Non-serious adverse event
reporting Accrual
Regulatory and governance issues
MHRA Good Clinical Practice GuideRisk Assessment –proportionateEMeA guidance pharmacokinetics, paediatrics and bacteria
1996/97
• ICH Guidelines on Good Clinical Practice
2001
• EU directive on Clinical Trials (2001/20/EC)
2001
• Research Governance Framework for Health and Social Care
2004
• Medicines for Human Use (clinical Trials) Regulations
2004
• Human Tissue Act (UK)
2005
• Mental Capacity Act (UK)
2005
• 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 requirementsDaily Temperature monitoring Drug accountability recordsPharmacovigilance reporting Substantial amendmentsInspections
Low to high risk Type A Type B Type C
Wider remit Systematic Reviews Health Economics Clinical Research Networks Negotiations with pharmaceutical
industry
N
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• 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
Commissioning & funding research
Streamlined and simple knowledge management systems
CTU ↑
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 [email protected]
North West Hub Liverpool Lancaster and Bangor
to improve patient care by improving the validity and relevance of the healthcare evidence base
3 themes1.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 opportunitiesOnline 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 HillSenior Regional Advisor – Clinical Trials/Research Design Service
Pancreatic cancerHead and neck cancers Lung cancer Haematology Palliative care cancer work Urological cancers Pharmacogenetics
and non-cancer trials
Liverpool Cancer Trials Unit
Clinical Trials Research Centre(UOL based at Alder Hey Children’s NHS FT)
Medicines for Children (except cancer)Pharmacogenetics Infection NeurologyReproductive and child health Vision Science
and more
Manchester Academic Health Science Centre Trials Co-ordination UnitChristies Trials Co-ordinating Unit
Cancer Mental Health Metabolic and Endocrine
and more
NIHR Support – and resourcesTopic Specific Research Networks
Comprehensive Research
Network
Diabetes
Medicines for
Children
Dementia and Neuro-degenerati
ve
Stroke
Primary
Care
National Cancer
Mental Health
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