Network of Hubs for Trials Methodology Research

Mike Clarke, Chair

Network of Hubs

All-IrelandCambridge (MRC BSU)ConDuCTEdinburghLondon (MRC CTU)MidlandsNorthwestOxford (MRC CTSU)

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.

COMET website

Search results

By the end of 2011, there had been 1712 visits (including 1049 unique visitors from 53 countries) with a total of 7634 page views and 288 completed database searches.

Network adviceMethodological Advisory Service for Trials (MAST)• Available to CTUs• Online, with queries triaged to MAST advisors• Advice at any stage of a trial

MAST

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? www.methodologyhubs.mrc.ac.uk/

Mapping Training Courses• Hubs have prepared a preliminary list of training specific to

trials methodology.

• Mixture of workshops, short courses, and modules.

• We would like to develop this in collaboration with CTUs, to provide a key resource for trialists and others seeking training.

ExcerptTitle Brief description Institution Frequency Information

Introduction to research governance

Two-day course covering all aspects of research governance for clinical trials

University of Bristol Annual www…

Data and safety monitoring boards (DSMBs)

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.

University of Lancaster www…

Clinical trials One-day course covering basic concepts in the design, ethics, conduct, analysis and publication of randomized trials, including practical exercises and examples.

University of Cambridge www…

Design and analysis of randomised trials

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.

University of Bristol Annual www…

Edinburgh clinical trial management course

Two-day course covering management of randomised trials.

University of Edinburgh Annual www…

Randomised trials Five-day course covering practicalities of organising and running a trial.

University of Oxford www…

Working together• Working groups (Adaptive Designs; Trial

Recruitment; Trial Conduct; Evidence Synthesis; Outcomes; Stratified Medicine)

• Collaborative projects (COMET, trial monitoring, recruitment, …)

• Prioritisation of methodological research• Conduct of methodological research (SWATs)• MAST• International Clinical Trials Day (2012)• Clinical Trials Methodology Conference (2013)• Joint meetings of CTU and Hub Directors