UKCRC Registered Clinical Trials Unit Network

1. UKCRC Registered Clinical Trials Unit Network Work Programme & Future of the Network CTU Directors’ Meeting, January 2012 Presented by Professor Paula Williamson UKCRC Registered CTU Network

2. What has happened since last meeting? • Network administrator appointed June 2011, Saeeda Bashir (s.bashir@leeds.ac.uk) • Funding agreed and received for 1 year from BHF, ARUK, NIHR, WORD, CSO • Working Group established, met twice Membership: Funders • Sarah Rudkin, Arthritis UK (Chair) • Michael Bowdery, Wales • Tom Walley, NETSCC CTU Representatives • Julia Brown, Director UKCRC Registered CTU Network (j.m.b.brown@leeds.ac.uk) • Paula Williamson, Director CTRC (p.r.williamson@liverpool.ac.uk) • Rhiannon Whitaker, (r.whitaker@bangor.ac.uk) • Adrian Bloor, Director (Adrian.bloor@christie.nhs.uk) • Ian Ford (Ian.Ford@glasgow.ac.uk) • Lorraine Smith (Lorraine.Smith@ed.ac.uk ) • Janet Darbyshire Clinical Research Network • Jonathan Sheffield

3. Registration process developed with Working Group • UKCRC umbrella agreed, competencies agreed, timelines agreed, application form designed, workshop for new applicants organised, international review panel convened, date set for review

4. Membership fee structure developed • Agreement for underwriting from key funders if required • New website under development • Newsletter, survey of Directors, Directors meeting, input into consultations on behalf of network, MHRA/DoH/MRC Risk Assessment Working Group • Industry Interaction scoping group established – met once • Rik Kaplan MRC CTU • Rury Holman, Diabetes CTU • Ian Ford, Glasgow CTU • Jenny Gray, NCRN Industry lead • Fiona Brain, NIHR CRN Industry lead • Work Programme agreed with Working Group, CTUs and funders

5. Work programme • UK Registration Process with review of currently registered Units based on an International Panel Review model and annual review of status. • Networking opportunities between UKCRC Registered CTUs enabling: • common approaches to addressing issues across Registered CTUs resulting in optimisation of resources • facilitation of shared best practice amongst Registered CTUs including mentorship of developing CTUs resulting in increased quality systems and processes across the Registered CTUs • opportunities for CTUs to contribute to new developments and initiatives within the clinical research community (funders, networks, and regulators) • greater visibility of Registered CTUs providing easy access to information about their expertise to other stakeholders, particularly funders and clinical investigators • academic/industry partnerships to become more attractive resulting in increases in collaboration • development of more coordinated approach to the DMCs and TSCs Biannual CTU Directors meetings, biannual meetings for CTU Operational staff (Information Systems, statisticians and quality assurance representatives), continuation of existing communication routes – JISC Mail, ‘The Exchange’ Newsletter. In addition a new interactive website will be developed and maintained to facilitate information exchange between CTUs for all disciplines and levels of staff.

6. Work Programme (contd) • Creation and support for the following Working Groups:  • Industry To explore frameworks for facilitating and publicising collaborations with industry and small to medium enterprise and medical device companies. To share previous experiences of working with industry to achieve greater transparency and consistency into academic industry collaborations, addressing key issues such as IP and publications policy. • Core Infrastructure A UK-wide review of Registered CTU core infrastructure funding with the aim of mapping the availability of resources and expertise to support design and delivery of clinical trials. Interaction with a range of funders and host institutions to publicise the importance and benefits of core infrastructure funding in the delivery of cost effective high quality clinical trials • Costing Models Development of a standardised approach to costing studies. The aim of this initiative is to increase transparency, consistency and clarity in funding applications to assist both applicants and funding bodies. • Operational themed meetings -Quality Assurance, Information Systems and Statistics in order to share best practice and to help develop standard approaches to common issues.

7. Work Programme (contd) Representation of CTUs on national/ international groups and in national/international consultations • The Registered CTUs will be represented on key strategy and consultation groups (e.g. MHRA GCP Consultative Committee, MHRA/DoH/MRC Risk Assessment Working Group, NETSCC Trials Unit Advisory Group). CTU views on relevant consultations from national or international bodies e.g. the EU or MHRA will be collated and submitted. Publicity for the UKCRC Registered CTUs • A dedicated online resource presenting a branded identity and showcasing the Registered CTUs through an online directory of Registered CTU research interests and contact details. • Publicity material for funders, industry, small to medium enterprises, collaborators which showcases the Registered CTUs and highlights the importance of and benefits of engagement with Registered CTUs in terms of cost effective high quality delivery of clinical trials Focus for interaction with MRC Methodology Hubs Network and NIHR Research Design Services

8. What are CTUs getting from the network and the work programme? • Visible profile to facilitate access to and integration of UKCRC Registered CTUs with key stakeholders, in particular research funders (including industry), research networks, regulators, and investigators • Raising profile with and understanding of our collaborators, funders, host institutions • Focussed contact point facilitating engagement with stakeholders and ensuring CTUs have opportunity to contribute to key national initiatives and developments (eg MRC Methodology Hubs) • Efficiency and improvement in delivery through sharing best practice and SOPs • Avoidance of duplication of effort and standardising systems (e.g DIMs) • Peer support for common issues (SharePoint; JISCmail) • External recognition of quality – eligibility for new funding initiatives (e.g. NIHR CTU Pump Priming Funding) • Collaborative approach to addressing national issues (e.g. CTU capacity) • Networking with UK CTU Directors, for statisticians, IS, QA • Representation at national / international level • Mentoring (if required)

9. Funding model • Upfront fee for registration review (£500) • Review every 3 years with annual self assessment sign off • Annual fee to cover work programme • Amount to be adjusted depending on outcome of registration process • Likely to be around £2,000 per annum • Lean structure to keep costs down • Reviewed by working group

10. Next 6 months a lot of focus on registration process • Development of new interactive website • Then move to establishing Sub Groups • Propose 10 members • Invite applications – review by Working Group

11. 2012 Registration Process • Key dates for review • Application process open Jan 2012 • Deadline for completed applications 6 April 2012 • Review early July 2012 • Outcome September 2012 • Application form available from website • Key differences • Simplified • Section 1 Overall summary • Details of 5 (3) open, in follow-up, analysis multi centre rcts, 1 in NIHR portfolio, at least 2 (1) open • 3 (1) trial publication of existing/closed trial - front page of each showing author contributions

12. 2012 Registration Process • Section 2 Staffing • Overall staffing, cvs of 2 (1) statisticians,2 (1) trial/project managers, 2 (1) IT person(s) • Section 3 Infrastructure • Statement of support from host institution • Details of how you ensure long term continuity • Section 4 Quality Assurance • List of Essential SOPs (8 new, deviations and serious breaches, urgent safety measures, sponsorship, system validation, database development, database change management, business continuity and disaster recovery) • How you manage quality assurance, risk assessment and monitoring

13. 2012 Registration Process • Section 5 Information Systems • How data is collected • Info on database systems and their management • Section 6 Extent of availability • Section 7 Signatures • Section 8 Collaborative Group information

14. International Review Panel Clinical epidemiology Clinical Trials Unit Director Experienced triallist Information Systems Trial Management Statistics Funder/ triallist Statistics

18. Questions?