Midland Hub for Trials Methodology Research at University of Birmingham

Lead Research Organisation: University of Birmingham
Department Name: Cancer Sciences

Abstract

Clinical trials test potential treatments in humans to see if they should be approved for wider use in the general population. Any new treatment must be extensively tested to check that it benefits patients, is safe and doesn t have unacceptable side effects. Most often the treatment is a drug, but it could be a medical device, a surgical or physical procedure, a therapy or an intervention such as health promotion. Volunteers are recruited into the clinical trial to undergo the new treatment and usually the trial will include a group who just receive the standard treatment. In this way, the outcome of patients on the new treatment can be compared to the standard to see if it is beneficial. Planning how the trial will be run and making sure it addresses the right questions are important to ensure that the results from the trial will be useful. Interpreting the data that is collected in the trial also needs to guarantee that valid conclusions are reached. The plan for this research is to create a regional facility at the University of Birmingham in which to investigate the best ways to design, conduct and analyse trials, providing advice, support and training to those carrying out trials and to the public. Ultimately this will result in beneficial treatments being delivered to patients more efficiently.

Technical Summary

The aim of the Midland Hub at University of Birmingham is to be a centre of excellence for trials methodology research, providing local and national researchers undertaking trials with innovative methodology for design, conduct and analysis, thereby improving the quality of trials. The Hub will develop existing expertise in trials methodology at Birmingham to deliver a high-quality Research Programme that will be of practical use to the trials community. There is a culture of collaborative working at Birmingham and the Hub will continue to cultivate regional, national and international collaborations to facilitate the successful delivery of research. A comprehensive training programme in trials methodology will train the potential experts of the future and educate trial practitioners in methodology. By providing a mechanism for advice, support and dissemination the Hub will benefit the trials community and ultimately patient care.
Our proposed research programme centres around the current specialist methodological areas but the wealth of expertise will enable us to develop new research themes identified as important by the clinical trials community. There are seven key research themes at Birmingham: (1) Quality of life evaluation for clinical and health economic assessment; (2) Discovery and evaluation of diagnostic, prognostic and predictive biomarkers; (3) Methods to obtain reliable conclusions and involve users; (4) Bayesian methods in design and analysis of trials; (5) E-trials; (6) Systematic review for clinical and health economic assessment; (7) Education in trial methodology. Methodological expertise within the Research Programme feeds into all major areas within the trial process i.e. pre-trial development, trial design and set-up, trial conduct, trial analysis and evidence synthesis.
In summary, Birmingham is at the heart of the trials community, providing academic expertise based on real-life trial experience, ready access to a wealth of datasets that can be used for methodology research, real situations in which to implement new methodology and direct support to many members of the clinical trial community. As one of the leading centres in the UK for clinical trials, the University of Birmingham is the ideal location for the Midland Hub for Trials Methodology Research.

Publications

10 25 50

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Abo-Zaid G (2013) Individual participant data meta-analyses should not ignore clustering. in Journal of clinical epidemiology

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Al-Janabi H (2011) QALYs and carers. in PharmacoEconomics

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Al-Janabi H (2011) Estimation of a preference-based carer experience scale. in Medical decision making : an international journal of the Society for Medical Decision Making

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Al-Janabi H (2013) Can capabilities be self-reported? A think aloud study. in Social science & medicine (1982)

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Al-Janabi H (2013) An investigation of the construct validity of the ICECAP-A capability measure. in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation

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Al-Janabi H (2012) Development of a self-report measure of capability wellbeing for adults: the ICECAP-A. in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation

 
Description Department of Health Research Support Facility funded PhD studentship
Amount £61,556 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 06/2010 
End 06/2013
 
Description European Commission Seventh Framework Programme (FP7)
Amount £250,000 (GBP)
Organisation European Commission 
Department Seventh Framework Programme (FP7)
Sector Public
Country European Union (EU)
Start 12/2011 
End 12/2016
 
Description European Commission Seventh Framework Programme (FP7)
Amount £300,000 (GBP)
Organisation European Commission 
Department Seventh Framework Programme (FP7)
Sector Public
Country European Union (EU)
Start 01/2011 
End 01/2015
 
Description HTA
Amount £742,492 (GBP)
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start 09/2011 
End 03/2014
 
Description HTA 09/22/117
Amount £1,621,734 (GBP)
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start 04/2011 
End 10/2015
 
Description HTA 10/36/02
Amount £200,529 (GBP)
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start 12/2011 
End 05/2013
 
Description HTA 10/44/01
Amount £241,472 (GBP)
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start 01/2012 
End 06/2014
 
Description MRC
Amount £49,540 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 02/2011 
End 02/2012
 
Description MRC Hub Network funding
Amount £10,000 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 01/2011 
End 01/2012
 
Description MRC Partnership Grant for (PROGRESS)
Amount £980,410 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 03/2012 
End 03/2015
 
Description NIHR Doctoral Fellowship
Amount £300,000 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 01/2012 
End 12/2015
 
Description NIHR National School Primary Care Research
Amount £85,260 (GBP)
Organisation National Institute for Health Research 
Department School for Primary Care Research
Sector Academic/University
Country United Kingdom
Start 06/2011 
End 06/2014
 
Description NIHR Postdoctoral Research Fellowship
Amount £300,000 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 10/2009 
End 10/2012
 
Description NIHR Programme Grant
Amount £1,987,326 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 01/2011 
End 01/2016
 
Description NIHR RfPB
Amount £250,000 (GBP)
Organisation National Institute for Health Research 
Department Research for Patient Benefit
Sector Public
Country United Kingdom
Start 01/2011 
End 01/2013
 
Description Nova Scotia Health Research Foundation Establishment Grant Competition
Amount £96,780 (GBP)
Organisation Nova Scotia Health Research Foundation 
Sector Academic/University
Country Canada
Start 09/2011 
End 08/2013
 
Description Post Graduate overseas work experience placement scholarship College of Medicine and Denistry, University of Birmingham
Amount £3,100 (GBP)
Organisation University of Birmingham 
Department College of Medical and Dental Sciences
Sector Academic/University
Country United Kingdom
Start 02/2012 
End 03/2012
 
Description Queen Elizabeth hospital Birmingham Charity
Amount £69,432 (GBP)
Organisation Queen Elizabeth Hospital Birmingham Charity (QEHB) 
Sector Charity/Non Profit
Country United Kingdom
Start 10/2011 
End 09/2012
 
Title Developed numerous techniques for performing and estimating multivariate (random effects) meta-analysis models 
Description Developed numerous techniques for performing and estimating multivariate (random effects) meta-analysis models which synthesis multiple correlated outcomes. See associated published papers 
Type Of Material Data analysis technique 
Year Produced 2009 
Provided To Others? Yes  
Impact See associated published papers. Also, a workshop about how to perform multivariate meta-analysis at the RSS, and the methods have been implemented within the STATA module 'mvmeta' 
 
Title a database of all IPD meta-analysis articles published up to March 2009 
Description Developed (with Hub member Ghada Abo-Zaid) a database of all IPD meta-analysis articles published up to March 2009 
Type Of Material Database/Collection of Data/Biological Samples 
Year Produced 2010 
Provided To Others? Yes  
Impact Empirical research regarding how IPD meta-analyses are undertaken, how IPD is collected, the biases involved, and the necessary reporting standards and guidelines for improvement 
 
Description Biologic therapies for rheumatoid and psoriatic arthritis: Consensus models for decision-making 
Organisation Medical Research Council (MRC)
Department MRC ConDuCT Trials Methodology Hub
Country United Kingdom 
Sector Public 
PI Contribution extensive expertise in HTA modelling, and developed the Birmingham Rheumatoid Arthritis Model, which has been used to inform a number of NICE technological appraisals
Impact The immediate output will be the consensus statement which will set out the preferred model for decision-making in biologic therapies, as proposed by our independent group of clinicians, modelling experts, and regulators. We will also establish a collaborative modelling group through this process, and put together a grant application as described above. Finally, we will document the process through which consensus was achieved, along with insights for the successful development of preferred decision models in other disease areas
Start Year 2011
 
Description CTRad: Clinical Trials in Radiotherapy 
Organisation National Cancer Research Institute (NCRI)
Department NCRI Clinical and Translational Radiotherapy Research Working Group
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Chair of Phase III Workstream
Collaborator Contribution Methodology Workshop and papers in preparation
Impact Methodology Workshop and papers in preparation
Start Year 2009
 
Description Cochrane Prognosis Methods Group 
Organisation University of Oxford
Department Department of Statistics
Country United Kingdom 
Sector Academic/University 
PI Contribution Richard Riley is co-convenor of the International Cochrane Prognosis Methods Group (initiated in 2006) alongside Jill Hayden (Canada), Doug Altman (UK), Karel Moons (The Netherlands), and Katrina Williams (Australia).
Collaborator Contribution I am a co-convenor of the International Cochrane Prognosis Methods Group (initiated in 2006) alongside Jill Hayden (Canada), Doug Altman (UK), Karel Moons (The Netherlands), and Katrina Williams (Australia). We continually provide advice to national and international researchers conducting systematic reviews of prognosis studies. The convenors also provide recommendations for how prognosis information should be included in Cochrane Reviews of interventions, and if and when the Collaboration should formally introduce reviews of prognosis studies
Impact We continually provide advice to national and international researchers conducting systematic reviews of prognosis studies. The convenors also provide recommendations for how prognosis information should be included in Cochrane Reviews of interventions, and if and when the Collaboration should formally introduce reviews of prognosis studies
Start Year 2006
 
Description Reporting guidelines for Risk Prediction Models 
Organisation University of Oxford
Department Department of Statistics
Country United Kingdom 
Sector Academic/University 
PI Contribution Richard Riley is part of a collaboration (led by Gary Collins and Doug Altman, Oxford, and Karel Moons, Utrecht) developing reporting guidelines for prediction models. The group has produced an initial set of guidelines, that are currently being refined.
Collaborator Contribution I am part of a collaboration (led by Gary Collins and Doug Altman, Oxford, and Karel Moons, Utrecht) developing reporting guidelines for prediction models. The group has produced an initial set of guidelines, that are currently being refined.
Impact The group has produced an initial set of guidelines, that are currently being refined.
Start Year 2011
 
Description The PROGRESS initiative 
Organisation University College London
Department Institute of Epidemiology and Health Care
Country United Kingdom 
Sector Academic/University 
PI Contribution Richard Riley co-lead of the PROGRESS initiative (PROGnosis RESearch Strategy) alongside Harry Hemmingway, UCL, and Doug Altman, Oxford. Since 2009 we have organised 3 workshops that brought together 25 national and international experts (including journal editors, clinicians, statisticians, epidemiologists, and economists) across multiple disease fields to develop a framework for improving prognosis research. These workshops have led to a series of 4 articles that are being revised for the BMJ/PLoS Med, describing the four key aspects of prognosis research: overall prognosis, prognostic factors, prognostic models and predictive factors for stratified medicine. These articles serve as an introduction to the field of prognosis, and why it is important and the necessary steps toward improvement.
Collaborator Contribution I am a co-lead of the PROGRESS initiative (PROGnosis RESearch Strategy) alongside Harry Hemmingway, UCL, and Doug Altman, Oxford. Since 2009 we have organised 3 workshops that brought together 25 national and international experts (including journal editors, clinicians, statisticians, epidemiologists, and economists) across multiple disease fields to develop a framework for improving prognosis research. These workshops have led to a series of 4 articles that are being revised for the BMJ/PLoS Med, describing the four key aspects of prognosis research: overall prognosis, prognostic factors, prognostic models and predictive factors for stratified medicine. These articles serve as an introduction to the field of prognosis, and why it is important and the necessary steps toward improvement.
Impact 3 workshops that brought together 25 national and international experts (including journal editors, clinicians, statisticians, epidemiologists, and economists) across multiple disease fields to develop a framework for improving prognosis research. These workshops have led to a series of 4 articles that are being revised for the BMJ/PLoS Med, describing the four key aspects of prognosis research: overall prognosis, prognostic factors, prognostic models and predictive factors for stratified medicine. These articles serve as an introduction to the field of prognosis, and why it is important and the necessary steps toward improvement
Start Year 2009
 
Description 'Quality of Life Assessment in Cancer Research' workshop-Medical School, University of Birmingham 17.02.2011 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Primary Audience Health professionals
Results and Impact Participants (approx 80) attended a workshop of presentations which evoked questions, debates and discussions

request for further sessions
Year(s) Of Engagement Activity 2011
 
Description 'Quality of Life Assessment in Cancer Research' workshop-Medical School, University of Birmingham-17.11.2011 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Primary Audience Health professionals
Results and Impact Participants (approx 80) attended a workshop of presentations which evoked questions, debates and discussions

Request for further sessions
Year(s) Of Engagement Activity 2011
 
Description 2nd Clinical Trial Methodology Conference, Edinburgh 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Type Of Presentation Poster Presentation
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Using systematic reviews to identify research gaps -
a case study 131I-mIBG for the treatment
of neuroblastoma in children
Wilson, J et al

represented Midland hub for trials methodology research
Year(s) Of Engagement Activity 2013
URL http://www.methodologyconference2013.org.uk/
 
Description 2nd Clinical Trials Methodology Conference 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Type Of Presentation Poster Presentation
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Practical implementation of an adaptive phase I/II design in chronic myeloid leukaemia: evaluating both efficacy and toxicity using the EffTox design
Josephine N Khan1*, Christina Yap2, Richard Clark3, Nicola Fenwick1, David Marin4 1 Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK 2 MRC Midland Hub for Trials Methodology Research, University of Birmingham, Birmingham, UK 3 Department of Haematology, Royal Liverpool University Hospital, Liverpool, UK 4 Department of Haematology, Imperial College London, Hammersmith Hospital, London, UK

Represented Midland Hub for Trials Methodology Research
Year(s) Of Engagement Activity 2013
URL http://www.methodologyconference2013.org.uk/
 
Description 2nd Clinical Trials Methodology Conference 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Type Of Presentation Poster Presentation
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact FLEXIBLE TRIAL DESIGN IN A RARE CONDITION
Veronica Moroz1, Keith Wheatley1, 2, Martin McCabe3
1 Cancer Research UK Clinical Trials Unit, University of Birmingham; 2 MRC Midland Hub for Trials Methodology Research, University of Birmingham;
3 Institute of Cancer Sciences , Manchester Academic Health Science Centre , University of Manchester.

Represented Midland Hub for Trials Methodology Research
Year(s) Of Engagement Activity 2013
URL http://www.methodologyconference2013.org.uk/
 
Description 2nd Clinical Trials Methodology Conference 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Type Of Presentation Poster Presentation
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Challenges in the development of prognostic models
utilising clinical trials data
Kym IE Snell1, Lucinda J Billingham1,2, Deborah D Stocken3, Richard D Riley1
MRC Midland Hub for Trials Methodology Research, University of Birmingham, UK
2 Cancer Research UK Clinical Trials Unit, University of Birmingham, UK
3 Newcastle Clinical Trials Unit, Institute of Health and Society, Newcastle University, UK
Email: kxs105@bham.ac.uk

Represented Midland Hub for Trials Methodology Research
Year(s) Of Engagement Activity 2013
URL http://www.methodologyconference2013.org.uk/
 
Description Meeting on Stratified Medicine 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Primary Audience Health professionals
Results and Impact Workshop on stratified medicine

dissemination of knowledge on stratified medicine
Year(s) Of Engagement Activity 2010
 
Description Oral Presentation at NCRI Cancer Conference 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Primary Audience Health professionals
Results and Impact Speaker on 'Adaptive Trial Designs that Incorporate Biomarkers'

Provided knowledge for clinicians
Year(s) Of Engagement Activity 2011
 
Description Oral Presentation at World Conference on Lung Cancer 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Primary Audience Health professionals
Results and Impact Speaker to an international audience of lung cancer clinicians on 'How to design a meta-analysis in biomarkers'

Provided knowledge for clinicians
Year(s) Of Engagement Activity 2009
 
Description Oral Presentation at World Conference on Lung Cancer Young Investigators Day 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Primary Audience Health professionals
Results and Impact Speaker to international audience of young lung cancer clinicians on 'Trial Designs for Biomarker assessment'

Provided knowledge for clinicians
Year(s) Of Engagement Activity 2011
 
Description Poster presentation at NCRI Cancer Conference 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Primary Audience Health professionals
Results and Impact Poster Presentation at NCRI Cancer Conference 'Quality-adjusted survival analysis using the integrated quality survival product: comparison of utilities and profile measures using a large phase III randomised clinical trial in lung cancer'

knowledge for clinicians
Year(s) Of Engagement Activity 2011
 
Description Poster presentation at NCRI Cancer Conference 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Primary Audience Health professionals
Results and Impact Poster presentation at NCRI Cancer Conference 'Stratified medicine in practice: review of predictive biomarkers in European Medicines Agency Indications'

Knowledge for clinicians
Year(s) Of Engagement Activity 2011
 
Description Seminar at Keele Clinical Trials Unit 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Primary Audience Health professionals
Results and Impact Dissemination about Trials Methodology and Hubs

Potential collaboration on future trial designs
Year(s) Of Engagement Activity 2010
 
Description Seminar at Nottingham Clinical Trials Unit 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Primary Audience Health professionals
Results and Impact Dissemination about trials methodology and Hub

Potential collaboration on future trial designs
Year(s) Of Engagement Activity 2011
 
Description Seminar at Taunton Hospital 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Primary Audience Health professionals
Results and Impact 20 clinicians attended and learnt about interpreting results from lung cancer trials

Improved knowledge of clinical community
Year(s) Of Engagement Activity 2009
 
Description Swedish Lung Cancer Meeting 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Primary Audience Health professionals
Results and Impact National meeting of Swedish thoracic Oncologists

influence decisions regarding strategy for biomarker trials in lung cancer
Year(s) Of Engagement Activity 2010