MRC Network of Hubs for Trials Methodology Research Gordon Murray, University of Edinburgh

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1 Edinburgh All All Ireland Ireland North West Midlands MRC-CTSU - CTSU MRC MRC- - BSU ConDuCT MRC- - CTU MRC Network of Hubs for Trials Methodology Research Gordon Murray, University of Edinburgh

2 Network of Hubs All-Ireland Cambridge (MRC-BSU) ConDuCT Edinburgh London (MRC-CTU) Midlands North West Oxford (MRC-CTSU) Edinburgh All All Ireland Ireland North West Midlands MRC-CTSU - CTSU MRC MRC- - BSU ConDuCT MRC- - CTU

3 Current focus of MRC activity Discovery and exploratory research MRC lead Application and delivery research NIHR lead Genetics/genomics Structural biology Imaging Systems medicine Global health Ageing: life course Stem cells Pharmacogenomics Animal/human models Regenerative medicine Experimental medicine Methodology Global health Stratified medicine HTA Trials EME Trials (Late stage III) Programmes in Applied research Research for Patient Benefit Invention for Innovation Infections Population science Public health Service Delivery and Organisation E-health CSO (Scotland) WORD (Wales) HSCNI (Northern Ireland)

4 Network of Hubs Eight Hubs for Trials Methodology Research have been established by the Medical Research Council since 2009, creating a regionally distributed resource to help improve the design, conduct, analysis, interpretation and reporting of clinical trials. The Hubs build on their individual research interests and work together as a Network, in four related areas: promoting high quality collaborative methodological research, both between Hubs and with other groups, UK-wide and internationally; providing methodological advice to the clinical trials community; encouraging the use of the most effective and appropriate methodological practice (e.g. through education and training); working with stakeholders, in particular to agree on shared priorities for research and guidance and to advocate for improvements in the conduct of clinical trials.

5 Where the Network fits Scottish Clinical Research Network MRC Institute MRC Unit MRC HTMR Methodology hubs UKCRN CTU Northern Ireland Clinical Research Network Wales Clinical Research Network

6 Working Groups Evidence Synthesis in Trial Design Outcomes Trial Recruitment Working Groups Trial Conduct Adaptive Trial Designs Stratified Medicine There are currently six working groups to focus on strategic areas of interest to the Network and its stakeholders. Key outputs of the Working Groups to date include: Obtaining Network funding for Trial Monitoring Project (Conduct) Obtaining Network funding for multi-arm-multi-stage trial designs and further development funding from the MRC (Adaptive Designs)

7 Network Project funding The Network has funded 27 Projects to date on diverse areas including: Randomised Surgical Trials: Methods to Improve Recruitment and Study Design (workshop) The use of individual participant data (IPD) in systematic reviews (series of papers) Joint Projects with other funders e.g. Biologic therapies for rheumatoid and psoriatic arthritis: Consensus models for decision-making with Arthritis Research UK (workshop and consensus statement) CONSORT Extension on Quality of Life Reporting Standards Developing and assessing central statistical monitoring methods for multicentre clinical trials (development of statistical tools) And longer term Projects including DIRUM and COMET

8 Network Project: MAMS Cross-Hub research visits to discuss improving multiarm, multi-stage clinical trials A collaboration between MRC-BSU, MRC-CTU and the North West Hubs

9 Network Project: Surgical trials Randomised Surgical Trials: Methods to Improve Recruitment and Study Design (September 2011) A collaboration between ConDuCT, Midlands and the North West Hubs together with the Royal College of Surgeons of England Outputs include a journal article and podcast to summarise the workshop, and development of a risk assessment tool for researchers to use during the design of a trial in development Further funding obtained for a workshop on designing and reporting surgical trials

10 Network Project: DIRUM Database of Instruments for Resource-Use Measurement (DIRUM) for Trial-based Health Economic Evaluations DIRUM is a collaboration of the North West, Midlands and ConDuCT Hubs, and the London School of Economics and University of British Columbia. Website opening in June 2011 Workshop held in October 2011-Group and panel discussions resulted in a short listing of priority areas for defining a research agenda.

11 Network Project: DIRUM Demonstrated at the National Cancer Intelligence Network: Cancer Outcomes Conference 14th-15th June 2012 Article published in Value in Health: "Development of a Database of Instruments for Resource Use Measurement (DIRUM): Purpose, feasibility and design" The DIRUM research team received further funding to develop the resource in

12 Network Project: DIRUM- website By August 2012, there had been 3800 visits. DIRUM currently contains 38 instruments in 16 disease categories.

13 Network Project: COMET Core Outcome Measures in Effectiveness Trials COMET Meetings (January 2010 and July 2011) to bring together stakeholders: trialists, systematic reviewers, health service users, clinical teams, journal editors, trial funders, policy makers, people responsible for research registries and industry regulators COMET database containing relevant resources for core outcome sets in different diseases

14 Network Project: COMET- website

15 Network Project: COMET- search results By August 2012, there had been 7600 visits (including 4400 unique visitors from 93 countries) with a total of 32,000 page views and 1500 completed database searches.

16 Network advice Methodological Advisory Service for Trials (MAST) Currently available to CTU and RDS advisors Online, with queries triaged to MAST advisors Advice at any stage of a trial Enquiry Answered by Response Feedback from enquirer Design in a rare disease trial for grant application Midlands and North West Suggested references and possible Bayesian approach. Further design suggestions provided by telephone and suggestion of RSS workshop. Provided supporting documents It was tremendously helpful. The North West Hub provided excellent support and a document outlining a proposed strategy (with all supporting documents) for my grant application

17 Methodology training courses Hubs have prepared a preliminary list of training courses for clinical trials, including many which are specific to trials methodology. Mixture of workshops, short courses, and modules. We would like to further develop this to provide a key resource for all trialists and others seeking training.

18 Clinical trial training courses- current list Title Brief description Institution Frequency Information Introduction to research governance Data and safety monitoring boards (DSMBs) Clinical trials Design and analysis of randomised trials Edinburgh clinical trial management course Randomised trials Two-day course covering all aspects of research governance for clinical trials One-day course covering the remit and composition of DSMBs, and how their work relates to other parties involved in the study, such as the sponsor, the study project team, the investigators, the Steering Committee and the data management centre. One-day course covering basic concepts in the design, ethics, conduct, analysis and publication of randomized trials, including practical exercises and examples. Five-day course covering key issues in the design, analysis and reporting of clinical trials. The course focuses on randomised trials in the evaluation of healthcare technologies. Two-day course covering management of randomised trials. Five-day course covering practicalities of organising and running a trial. University of Bristol Annual www University of Lancaster University of Cambridge www www University of Bristol Annual www University of Edinburgh Annual www University of Oxford www

19 Save the date 2 nd UK Clinical Trials Methodology Conference: Methodology Matters November EICC, Edinburgh, UK more details and registration to follow