Helen Hill Senior Regional Advisor Clinical Trials hhill livacuk wwwctrcorguk Specialist units to design conduct analyse and publish clinical trials and other welldesigned studies ID: 1043832
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1. The Role of Clinical Trials UnitsHelen HillSenior Regional Advisor Clinical Trials hhill@liv.ac.ukwww.ctrc.org.uk
2. 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
3. 30 Fully Registered Clinical Trial Units+16 provisional or pendingRegistration 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.
4. 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 CentreNorth 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
5. 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 collaborativeContact Jenna Paglia jpaglia@liv.ac.ukNorth West Surgical Trials Centre Launch EventFriday 20th September 2013: Newton-le-Willows10.00am – 4.30pm
6. NIHR Clinical Trial Tool Kit (MRC DOH)http://www.ct-toolkit.ac.uk/routemap/trial-planning-and-designCTU Provide support at each stage
7. 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
8. 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 centrallyMulti centre site coordination and initiation (international) Patient Identification Centres or follow up sites **
9. 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
10. Regulatory and governance issues MHRA Good Clinical Practice GuideRisk Assessment –proportionateEMeA guidance pharmacokinetics, paediatrics and bacteria
11. 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 confidentialityMHRA Risk Proportionate Approach reduces regulatory requirementsDaily Temperature monitoring Drug accountability recordsPharmacovigilance reporting Substantial amendmentsInspections Low to high risk Type A Type B Type C
12. Wider remit Systematic Reviews Health Economics Clinical Research Networks Negotiations with pharmaceutical industry
13. NNIHR Clinical Trials Units Support Funding Birmingham Clinical Trials Unit -University of BirminghamBristol 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
14. When to involve a CTUAs early as possible!CTIMP (Clinical Trial Investigating a Medicinal Product)Multi-centre RCT (CTIMP/ nonCTIMP)Multi-centre pilot/ feasibilityMethodologyHigh riskProposed funder – e.g. NIHR HTA, EMECost of the service applies if funded
15. Commissioning & funding researchStreamlined and simple knowledge management systemsCTU ↑www.nihr.ac.uk
16. North West Research Design Service (RDS) NIHRDevelop and design research proposals for funding competitions NIHR Research for Patient Benefit Programme and Programme Grants for Applied Research)Liverpool, Lancaster and Manchester Universitieshttp://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 NHSResearch DesignFunding 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
17. MRC Hubs for Trials Methodology Research Regional centres of excellence clinical trial methodology. MAST Methodology Advisory Service for Trials non-standard methodologyenquiries@methodologyhubs.mrc.ac.ukNorth West Hub Liverpool Lancaster and Bangor to improve patient care by improving the validity and relevance of the healthcare evidence base3 themes1.Early phase trial design and analysis PK/PD2. Later phase trial design and analysis www.COMETinitiative.org 3. Patient perspectives - RECRUIT Funding extended for 5 years – today…
18. 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 UniversityTraining workshops, research dayswww.liv.ac.uk/nwhtmr
19. Thank you Helen HillSenior Regional Advisor – Clinical Trials/Research Design Service hhill@liv.ac.uk
20. Pancreatic cancerHead and neck cancers Lung cancer Haematology Palliative care cancer work Urological cancers Pharmacogenetics and non-cancer trials Liverpool Cancer Trials Unit
21. 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
22. Manchester Academic Health Science Centre Trials Co-ordination UnitChristies Trials Co-ordinating Unit Cancer Mental Health Metabolic and Endocrine and more
23. NIHR Support – and resourcesTopic Specific Research Networks
24. 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