MRC Network of Hubs for Trials Methodology Research

Gordon Murray, University of Edinburgh

www.methodologyhubs.mrc.ac.uk

Edinburgh

Midlands

MRC -

MRC - CTU

MRC - CTSU ConDuCT

All Ireland

Edinburgh

Midlands

MRC - CTU

MRC - CTSU ConDuCT

All Ireland

North West

Edinburgh

Midlands

MRC -

MRC - CTU

MRC - CTSU ConDuCT

All Ireland

Edinburgh

Midlands

MRC- BSU

MRC- CTU

MRC-CTSU ConDuCT

All Ireland

North West

Network of Hubs

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

Edinburgh

Midlands

MRC -

MRC - CTU

MRC - CTSU ConDuCT

All Ireland

Edinburgh

Midlands

MRC - CTU

MRC - CTSU ConDuCT

All Ireland

North West

Edinburgh

Midlands

MRC -

MRC - CTU

MRC - CTSU ConDuCT

All Ireland

Edinburgh

Midlands

MRC- BSU

MRC- CTU

MRC-CTSU ConDuCT

All Ireland

North West

Discovery and exploratory research Application and delivery research

MRC lead NIHR lead

Pharmacogenomics

Animal/human models

Regenerative medicine

Genetics/genomics

Structural biology

Imaging

Systems medicine

Global health

Ageing: life course

Stem cells

Infections

Population science

Experimental medicine

Methodology

Global health

Stratified medicine

Public health

E-health

HTA Trials

EME Trials (Late stage III)

Programmes in

Applied research

Research for Patient Benefit

Invention for Innovation

Service Delivery and Organisation

CSO (Scotland)

WORD (Wales)

HSCNI (Northern Ireland)

Current focus of MRC activity

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.

http://www.methodologyhubs.mrc.ac.uk/

Where the Network fits

MRC Institute

MRC Unit

MRC HTMR

Methodology hubs

UKCRN CTU

Scottish Clinical

Research Network

Northern Ireland Clinical

Research Network

Wales Clinical

Research Network

MRC Institute

MRC Unit

MRC HTMR

Methodology hubs

UKCRN CTU

Scottish Clinical

Research Network

Northern Ireland Clinical

Research Network

Wales Clinical

Research Network

Working Groups

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)

Evidence Synthesis in Trial Design

Trial Recruitment

Outcomes

Adaptive Trial Designs

Stratified Medicine

Trial Conduct

Working Groups

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

Network Project: MAMS

• Cross-Hub research visits to discuss improving multi-arm, multi-stage clinical trials

• A collaboration between MRC-BSU, MRC-CTU and the North West Hubs

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

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.

www.dirum.org

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 2012

www.dirum.org

Network Project: DIRUM- website

By August 2012, there had been 3800 visits. DIRUM currently contains 38 instruments in 16

disease categories.

www.dirum.org

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

www.comet-initiative.org

Network Project: COMET- website

www.comet-initiative.org

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.

Network Project: COMET- search results

www.comet-initiative.org

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

www.methodologyhubs.mrc.ac.uk/

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”

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.

Clinical trial training courses- current list

Title 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…

Save the date 2nd UK Clinical Trials Methodology Conference: Methodology Matters 18-19 November 2013- EICC, Edinburgh, UK more details and registration to follow