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UCL Clinical Trials Unit Launch

UCL Clinical Trials Unit Launch. 12 July 2012. UCL CTU Structure, Aims and Objectives. Professor Peter Brocklehurst. UCL CTU Structure, Aims and Objectives. CTU staff structure Mission statement UKCRC registration Trial types Linked centres UCL CTUs Collaborative CTU development

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UCL Clinical Trials Unit Launch

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  1. UCL Clinical Trials Unit Launch 12 July 2012 UCL CTU Launch 12 July 2012

  2. UCL CTU Launch 12 July 2012

  3. UCL CTU Structure, Aims and Objectives Professor Peter Brocklehurst UCL CTU Launch 12 July 2012

  4. UCL CTU Structure, Aims and Objectives • CTU staff structure • Mission statement • UKCRC registration • Trial types • Linked centres • UCL CTUs Collaborative • CTU development • Governance groups UCL CTU Launch 12 July 2012

  5. UCL CLINICAL TRIALS UNIT ORGANISATION CHART Academic Reporting Line UCL CTU Launch 12 July 2012

  6. UCL CTU Vision • To establish a world-class clinical trials unit to conduct high impact trials across a broad range of clinical specialties UCL CTU Launch 12 July 2012

  7. UCL CTU Mission Statement • The UCL Clinical Trials Unit will design, conduct, analyse and report high quality clinical trials and other well designed studies that fit with the research strategies of UCL • In pursuit of this Mission, the UCL Clinical Trials Unit will • Develop partnerships with clinical investigators at all relevant institutions • Promote a trial governance structure that supports a compliant, risk-based, proportional approach to the application of regulations • Provide clinical trials leadership and expertise across the whole range of activities required to deliver trials from concept to dissemination and implementation of research findings • Employ highly experienced staff with diverse research interests and expertise in clinical trial methodology to enhance the effectiveness of the research pathway  • The UCL CTU will accomplish its mission through CTU staff and collaborators supporting adoption of its policies and procedures UCL CTU Launch 12 July 2012

  8. UKCRC registration • Submitted for provisional registration April 2012 • Result expected by September 2012 UCL CTU Launch 12 July 2012

  9. Trial types that may be considered by CTU • Randomised controlled trials • Two-arm • Multi-arm • Adaptive designs • Factorial trials • Cluster randomised trials • All phases – Clinical Research Facility UCL CTU Launch 12 July 2012

  10. Trial types that may be considered by CTU • Drugs (IMPs) • Devices • Surgery • Lifestyle interventions (exercise, smoking cessation etc) • Information provision • Organisational change • etc UCL CTU Launch 12 July 2012

  11. Other study designs • Large observational studies • muticentre studies that require primary data collection • Where data collection systems have to be quality assured to a standard required of clinical trials UCL CTU Launch 12 July 2012

  12. Linked Centres • The CTU has established a hub and spoke arrangement with linked trial centres • The details of this relationship may vary depending on the facilities, resources and experience of the linked centre but the governing principles remain the same • Linked Centre Clinical Trial Lead acts as a conduit UCL CTU Launch 12 July 2012

  13. Linked Centres Hub and Spoke ModelCurrent Linked Centres UCL CTU Launch 12 July 2012

  14. Linked centres • UCL CTU hub main roles • Provides staff, skills and infrastructure expected within a registered CTU • Provide overarching SOPs • Provides or outsources IT for CTU trials: trial database, randomisation, SAE database, trial management systems • Leads the design and delivery of UCL CTU hub trials • Linked centres spoke roles • Comply with overarching SOPs • Have hub support at the appropriate level depending on local staff/skills and infrastructure • Perform gap analysis of what is available locally and what hub can provide • Methods of how to address the gaps identified will be for discussion with linked centres and is likely to be a mixture of hub support, locally available resources supplemented by appointments on trial grants UCL CTU Launch 12 July 2012

  15. UCL CTUs Collaborative • UCL Clinical Trials Unit • Director Peter Brocklehurst • CRUK & UCL Cancer Trials Centre • Director Jonathan Ledermann • PRIMENT • Directors Michael King and Irwin Nazareth • MRC CTU • Director Max Parmar • Aim to share • a number of best practices • training UCL CTU Launch 12 July 2012

  16. CTU Development • Development of areas of expertise • eg Surgery • Methodology • In collaboration with MRC Methodology Hub • Training in methodology eg PhD students • Teaching UCL CTU Launch 12 July 2012

  17. Governance UCL CTU Launch 12 July 2012

  18. CTU Oversight Groups UCL CTU Launch 12 July 2012

  19. Scientific Advisory Board (SAB) UCL CTU Launch 12 July 2012

  20. Senior Management Team(SMT) UCL CTU Launch 12 July 2012

  21. Trial Prioritisation Committee (TPC) UCL CTU Launch 12 July 2012

  22. Quality Management Group (QMG) UCL CTU Launch 12 July 2012

  23. UCL CTU Launch 12 July 2012

  24. Trials and Functional Groups Susan Tebbs UCL CTU Launch 12 July 2012

  25. Overview • Functional Groups • Trial portfolio • New trial adoption process UCL CTU Launch 12 July 2012

  26. Research area: methodology To improve patient outcomes through the timely collection of high quality, reliable, valid, cost effective data on which treatment recommendations are based. • Identifying and finding solutions to common problems in the design, conduct, analysis, interpretation and reporting of clinical trials and studies • Developing methods to improve trial conduct and quality • Adding to the available evidence on the most effective and appropriate methodological practice • Implementing the solutions through input to trial protocol and operational development, and through enhanced training of trial staff UCL CTU Launch 12 July 2012

  27. Health Economics • Health Economics component on clinical trial is increasingly demanded by funding bodies • Is intervention under evaluation value for money? • Trial design: Interventions being compared, appropriate measure of effectiveness outcome, time horizon, etc. • Data collection: Information on health care resource utilisation, unit costs, health-related quality of life, patient costs, etc. • Analysis: Cost-effectiveness model, extrapolation, imputation of missing values, uncertainty, value of additional information analysis, etc. UCL CTU Launch 12 July 2012

  28. Statistical Involvement • Review of collaboration requests • Study design • Choice of outcome measures • Sample size calculation • Randomisation • Select method and test the implementation • Trial conduct • Member of the trial team • Protocol and CRF development • Trial Monitoring • Analysis, reporting and dissemination UCL CTU Launch 12 July 2012

  29. The QA role at UCL CTU To ensure compliance with Clinical Trial Regulations, GCP and unit SOPs and Policies: • Review of quality-related documents e.g. risk assessment and quality management and monitoring plans • Audit e.g. if planned inspection • Writing UCL CTU SOPs and Policies • Ensure compliance across unit with UCL CTU SOPs and Policies • Review of monitoring reports andassistance with corrective and preventative action plans • Inspection preparation, involvement and follow-up • Assistance with any particular problems/document review before submission for approvals UCL CTU Launch 12 July 2012

  30. Training in the Clinical Trials Environment • Summary objective • to enable CTU staff to be qualified by training to carry out their role in the Unit and to maintain comprehensive, auditable records • Primary functions: • Identify performance gaps • Develop and deliver training • Source external training • Maintaining training records UCL CTU Launch 12 July 2012

  31. IT at CTU • Database application • Macro 4 • Randomisation • Tenalea • Document Management • EDGE UCL CTU Launch 12 July 2012

  32. Current Funded Trials • INFANT • BUMPES • RAPS • COMPARE • Crohns Imaging Study • HT Trial UCL CTU Launch 12 July 2012

  33. Other Trials • Funded 6 • Not funded or adopted 10 • Adopted & gone/going to grant application 5 • New trial enquiries 5 UCL CTU Launch 12 July 2012

  34. New Trials • Seeking CTU adoption/collaboration? • At least 3 months before the application deadline • Apply using the Collaboration Request Form available on the website • Send to enquiries@ctu.ucl.ac.uk UCL CTU Launch 12 July 2012

  35. New trial adoption process First steps • CI/deputy or Clinical Trial Lead(CTL) (from linked centres) completes a Collaboration Request Form • Available on request or on line • Reference # allocated • Triggers letter from CTU to CI/CTL acknowledging • Receipt of proforma • Informing of TPC meeting date that the trial will be reviewed • Advising CI/CTL that they (or delegate) should attend • Sending slide set for presentation • Call from CTU senior staff to discuss suitability and clarify any immediate issues UCL CTU Launch 12 July 2012

  36. New trial adoption process • TPC 1st Review meeting • Short presentation by Investigator • TPC has opportunity to discuss with Investigator • TPC completes a report template • Importance of scientific question • Is it feasible • Is it fundable (in the opinion of the TPC) UCL CTU Launch 12 July 2012

  37. 1st TPC Review ~ outputs UCL CTU Launch 12 July 2012

  38. 2nd TPC Review – feasibility of conduct 2 possible options based on risk assessment UCL CTU Launch 12 July 2012

  39. New trial adoption process • If funding successful: • 3rd TPC review • Amount of award? • Has it changed? • Amendments to the design required? • Is the CTU still able to manage the trial? UCL CTU Launch 12 July 2012

  40. Last TPC review2 possible options UCL CTU Launch 12 July 2012

  41. Working with the CTU • Collaboration • Design • Grant application • Delivery • Flexibility • Aim • To develop & deliver high quality trials to improve patient care • Trials that are compliant with the regulations UCL CTU Launch 12 July 2012

  42. Questions UCL CTU Launch 12 July 2012

  43. UCL CTU Website http://www.ucl.ac.uk/ctu Steve Hibbert UCL CTU Launch 12 July 2012

  44. Navigating to the website Two useful pages How to contact us How to work with us Other information on the website includes; staff profiles and current research areas. UCL CTU Launch 12 July 2012

  45. UCL CTU Launch 12 July 2012

  46. UCL CTU Launch 12 July 2012

  47. UCL CTU Launch 12 July 2012

  48. UCL CTU Launch 12 July 2012

  49. UCL CTU Launch 12 July 2012

  50. Questions UCL CTU Launch 12 July 2012

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