Update on Paediatric Research under the umbrella of the Medicines for Children Research Network. Dr Charlie Orton Ph.D Local Research Network Manager The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the National Institute for Health Research and the UK Clinical Research Network The origins of MCRN • Part of the Infrastructure arm of Best Research for Best Health (2006). • NIHR CRN – tCRNs – LRNs – NHS Organisations & Universities. • National competitive bidding resulted in Liverpool University being awarded with the responsibility of hosting the MCRN Co-ordinating centre. • Subsequent national competitive bidding then took place for NHS Trusts to host local research networks – 6 LRNs resulted that cover 50% of the paediatric population of England. • Contracts were signed in April 2006 and immediate recruitment of staff The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the National Institute for Health Researchbegan. and the UK Clinical Research Network Professor Rosalind Smyth Director, Dr Vanessa Poustie Assistant Director of the MCRN Co-ordinating Centre 1. Greater Manchester, Cumbria & Lancashire LRN – Dr Peter Clayton Director, Dr Nick Webb Deputy Director, Ms Sarah Rickard Manager. Manchester Children’s NHS FT. 2. Cheshire, Merseyside & North Wales LRN – Dr Matthew Peak & Dr Jo Blair Co-Directors, Dr Charlie Orton Manager. Alder Hey Childrens NHS FT 3. Trent LRN – Dr Alan Smyth Director, Mr Mark Howells Manager. Nottingham University Hospital Trust 4. West Midlands LRN – Dr Warren Leany Director, Dr Sam Hayton Manager. Birmingham Children’s NHS FT 5. SENCE (London SE, North Central & E) LRN – Dr William van’t Hoff Director, Dr Nick Croft & Dr Shane Tibby Co-Directors, Dr Paula Hurley & Sharon ? CoManagers. Great Ormond Street 6. South West LRN – Professor Adam Finn Director, Dr Andrew Collinson Co-Director, Dr Ruth Allen Manager Bristol Royal Infirmary The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the National Institute for Health Research and the UK Clinical Research Network “To facilitate the conduct of randomised clinical trials and other well designed studies of medicines for children, including those for prevention, diagnosis and treatment” The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the National Institute for Health Research and the UK Clinical Research Network Infrastructure of MCRN Co-ordinating centre • Clinical Study Groups, panels of experts in 14 specialties: – – – – – • Paediatric Clinical Trials Unit provides support on all aspects of trial design and management: – – – – – – – – • Develop and oversee the portfolio of studies Propose and develop new studies Consider studies proposed by others and advise on adoption into the portfolio Provide specific expert advise to investigators Ensure consumer involvement in all activities Grant applications Protocol and case report form development Sponsorship Legislative Frameworks Regulatory Authority and Ethics Submissions Design and analysis of trials Data management and IT requirements Preparation of reports for data monitoring and committees The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the National Institute for Health Study Adoptions Committee - Research later and the UK Clinical Research Network MCRN Work streams • Industry – Supported by a manager and liaison officer. Guide companies through MCRN processes of adoption, send out feasibility requests & provide reports on the commercial portfolio. • PPI – Supported by a co-ordinator who has set up a consumer group. • Training & Education – Supported by a co-ordinator & a steering group. • Formulations – Supported by formulation scientists, pharmacists and University Laboratories. • Experimental Medicine – Supported by NIHR. Strategy development to investigate new compounds. The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the National Institute for Health Research and the UK Clinical Research Network Process – MCRN adoption • Study Adoptions Committee – must be applied to in order to enter the portfolio and access LRN support. Whether commercial, non-commercial or investigator led, the committee will consider applications from sponsors who’s study meets all of the following eligibility criteria: • • • • – Funded through open national competition by recognised/approved bodies – Undergone scientific peer review – Meet the remit of medicines for children Once on the portfolio local research networks are approached to establish if resource is available to support the study. Negotiative process utilising local knowledge. Commercial studies are adopted on an ad hoc basis and often undergo rigorous feasibility surveys prior to adoption during recruitment strategy development. Non-commercial studies are adopted twice monthly when the committee meet via teleconference. SAC recommends investigators make contact with at least one of the support mechanisms available prior to submitting for adoption and as early as possible in the process of study development e.g. CSG, CTU. The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the National Institute for Health Research and the UK Clinical Research Network Once adopted onto the portfolio • LRNs are given information about studies going forward to adoption as early as possible. • Sites may have already been chosen or additional sites may need to be found. • At an appropriate point contact is made between the relevant LRN and the study team (CI, Co-ordinator, CTU). • Enter into a working partnership to identify support needs, plan operational roll out of the study, set up the study and ensure patients are given the opportunity to enroll in a study in the best manner possible. The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the National Institute for Health Research and the UK Clinical Research Network LRN support • Anything and everything you can think of! • LRN workforces consist of: Research nurses, research officers, pharmacists, data managers, administrators and is led by individuals who are highly experienced in the conduct of clinical research. • Directly support principal investigators to achieve shorter set up times, improved recruitment and compliance, understand regulatory affairs, contracts and costings and liaise with service support departments on their behalf. The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the National Institute for Health Research and the UK Clinical Research Network MCRN current portfolio 92 studies see separate excel spreadsheet……. The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the National Institute for Health Research and the UK Clinical Research Network Performance Measurement • All LRNs and the co-ordinating centre are performance managed by the DoH. • MCRN performance measures are very similar to all other research networks: – – – – Balanced portfolio Set up times Number of patients recruited to a clinical study Number of studies recruiting to target and closing on time The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the National Institute for Health Research and the UK Clinical Research Network MCRN performance – accrual. Number of patients MCRN cummulutive patient accrual to date 10000 7765 8000 6000 4204 4000 2000 MCRN Accrual 363 0 2007 2008 2009 Linear (MCRN Accrual) Average time to achieving 100% target accrual from date site activated = 253 days. Snapshot 01/05/Year The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the National Institute for Health Research and the UK Clinical Research Network MCRN Triennial Review January 2009. • MCRN classed as ‘outstanding’ • Awaiting final report • Some recommendations: – Expanding geographically – Share best practice between the 6 LRNs – Mapping of paediatric populations Copies of the report submitted for the review are available – please ask me for one! The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the National Institute for Health Research and the UK Clinical Research Network For more information please go to: WWW.mcrn.org.uk Thank you for listening! The NIHR Cheshire Merseyside and North Wales Medicines for Children Research Network is part of the National Institute for Health Research and the UK Clinical Research Network