ctrc.uk

1. The Role of Clinical Trials UnitsHelen HillSenior Regional Advisor Clinical Trials hhill@liv.ac.uk www.ctrc.org.uk

2. Clinical Trial + Units Specialistunits to design, conduct, analyse and publish clinical trials and other well-designed studies. Expertstatistical, epidemiological and other methodological advice Co-ordinationof trials involving investigational medicinal products (CTIMP) within the UK Medicines for Human Use CT Regulations resulting from the EU Directive for Clinical Trials.

3. 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.

4. 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

5. 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

6. CTU Provide support at each stage NIHR Clinical Trial Tool Kit (MRC DOH) http://www.ct-toolkit.ac.uk/routemap/trial-planning-and-design

7. 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

8. Clinical Trial Set up • Trial Supplies (IMP Investigational Medicinal Product) ** • Case report form development (infermedMACRO) • 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 **

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 risk • Serious and Non-serious adverse event reporting • Accrual

10. Regulatory and governance issues • MHRA Good Clinical Practice Guide • Risk Assessment –proportionate • EMeAguidance 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 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

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 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 - Bartsand 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 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

15. CTU ↑ Commissioning & funding research Streamlined and simple knowledge management systems www.nihr.ac.uk

16. 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

17. MRC Hubs for Trials Methodology ResearchRegional 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…

18. Hub educational opportunities www.liv.ac.uk/nwhtmr • 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

19. Thank you Helen Hill Senior Regional Advisor – Clinical Trials/Research Design Service hhill@liv.ac.uk

20. Liverpool Cancer Trials Unit • Pancreatic cancer • Head and neck cancers • Lung cancer • Haematology • Palliative care cancer work • Urological cancers • Pharmacogenetics and non-cancer trials

21. 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

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