North West HTMR

Lead Research Organisation: University of Liverpool
Department Name: Medical Statistics and Health Evaluation

Abstract

The best method for finding out whether one treatment is better than another is to perform a research study known as a randomised controlled trial, in which treatments are allocated to patients at random, rather like throwing a dice to decide. Studies like this are not without their difficulties. For example, when drugs are first trialled, the research should proceed in stages with evaluation at each stage. As treatments move into the later phases of study, researchers must choose which outcomes are most important to measure, a decision ideally arrived at through consideration of both the clinical and patient perspective. This proposal is to create a world-class centre where issues such as these facing the clinical trials community can be investigated, the overall aim being to improve patient care by improving the evidence on which decisions about healthcare are based.

Technical Summary

The gold standard study design for determining efficacy of a treatment is the randomised controlled trial (RCT) but trials are not without their difficulties (Prescott et al, 1999). This proposal is to create a world-class centre where methodological issues facing the clinical trials community can be investigated, the overall aim being to improve patient care by improving the validity and relevance of the healthcare evidence base. This will include provision of a training programme that will deliver individuals with the capacity to be leading clinical trialists and methodologists.

The Hub will focus on selected methodological research themes, initially developing and translating the methods for application across four clinical areas. The methodological areas include the promotion, modification and implementation of recently devised methods for improving the efficiency of a wide variety of early phase trials, the enhancement of the link between the findings of systematic reviews and the design of later phase trials particularly in relation to outcome selection (Clarke 2007, Sinha 2008), the development and application of methods of adjustment for non-compliance in both clinical and cost effectiveness analyses, and ensuring that the design and conduct of trials over their entire lifecourse is informed by evidence on the perspectives of patients. This will enable the design, interpretation, and dissemination of the results of RCTs that are of greater relevance to stakeholders.

Publications

10 25 50
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Aronson JK (2012) Defining rewardable innovation in drug therapy. in Nature reviews. Drug discovery

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Bonnett Laura (2012) Prognostic factors for epilepsy

 
Description An assessment of the impact of outcome reporting bias in randomised controlled trials within systematic trials
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
 
Guideline Title NICE Guideline
Description Citation in clinical guidelines
Geographic Reach National 
Policy Influence Type Citation in clinical guidelines
 
Description HTA outline proposal form now includes reference to COMET
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Impact of outcome reporting bias
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Implications for driving
Geographic Reach National 
Policy Influence Type Participation in advisory committee
Impact Providing evidence to coincide with currently recognised UK guidance on driving for patients with epilepsy. From this a change in policy has resulted in the UK and it is planned to use this analysis to harmonise EU and UK driving regulations. This work is not directly related to trials methodology but this demonstrates added value since work benefited from methods applied to analysis of trials data.
 
Description Methods referred to in Cochrane handbook
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Paediatric asthma COS/COMET: response to EMA
Geographic Reach Asia 
Policy Influence Type Participation in a national consultation
 
Description SPIRIT 2013 guidance for protocols of clinical trials now includes reference to COMET
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Butterfield Awards for UK-Japan Collaboration in Medicine and Health
Amount £3,000 (GBP)
Organisation The Great Britain Sasakawa Foundation 
Sector Charity/Non Profit
Country United Kingdom
Start 09/2012 
End 08/2013
 
Description Career Development Fellowship
Amount £301,658 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start  
 
Description Cochrane Programme Grant
Amount £480,000 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 01/2011 
End 01/2014
 
Description Framework Programme 7
Amount € 497,368 (EUR)
Organisation European Commission 
Department Seventh Framework Programme (FP7)
Sector Public
Country European Union (EU)
Start 10/2012 
End 09/2014
 
Description MRC Trials Methodology Fellowship
Amount £166,000 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 09/2014 
End 08/2017
 
Description MRC/ARUK Musculoskeletal Ageing Centre (Liverpool/Sheffield/Newcastle)
Amount £1,875,000 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start  
 
Description MRC/ARUK Musculoskeletal Ageing Centre (Liverpool/Sheffield/Newcastle)
Amount £625,000 (GBP)
Organisation Versus Arthritis 
Start  
 
Description Methodology Panel Award
Amount £685,814 (GBP)
Funding ID G0902155 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 11/2011 
End 05/2013
 
Description Methodology Research Panel
Amount £173,273 (GBP)
Funding ID MR/J004847/1 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 11/2012 
End 10/2014
 
Description Methodology Research Panel
Amount £549,000 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 04/2012 
End 03/2015
 
Description NIHR
Amount £30,000 (GBP)
Funding ID RMOFS 2012/09 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 10/2013 
End 09/2014
 
Description NIHR HTA
Amount £1,536,010 (GBP)
Funding ID 12/127 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 06/2014 
End 08/2018
 
Description Network of Hubs for Trials Methodology Research R1
Amount £50,000 (GBP)
Funding ID R1 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 08/2010 
End 07/2011
 
Description Network of Hubs for Trials Methodology Research R13
Amount £2,300 (GBP)
Funding ID R13 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 05/2011 
End 12/2011
 
Description Network of Hubs for Trials Methodology Research R14
Amount £15,712 (GBP)
Funding ID R14 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 09/2011 
End 12/2012
 
Description Network of Hubs for Trials Methodology Research R18
Amount £46,220 (GBP)
Funding ID R18 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 05/2012 
End 04/2013
 
Description Network of Hubs for Trials Methodology Research R19
Amount £36,314 (GBP)
Funding ID R19 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 03/2012 
End 02/2013
 
Description Network of Hubs for Trials Methodology Research R24
Amount £16,052 (GBP)
Funding ID R24 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 09/2012 
End 08/2013
 
Description Network of Hubs for Trials Methodology Research R30
Amount £49,082 (GBP)
Funding ID R30 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 10/2012 
End 09/2013
 
Description Network of Hubs for Trials Methodology Research R31
Amount £12,721 (GBP)
Funding ID R31 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 10/2012 
End 05/2013
 
Description Network of Hubs for Trials Methodology Research R46
Amount £7,000 (GBP)
Funding ID R46 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 01/2014 
End 11/2014
 
Description Network of Hubs for Trials Methodology Research R5
Amount £32,523 (GBP)
Funding ID R5 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 01/2011 
End 02/2012
 
Description Network of Hubs for Trials Methodology Research R7
Amount £12,941 (GBP)
Funding ID R7 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 11/2010 
End 06/2011
 
Description Post-doctoral Research Fellowship
Amount £169,000 (GBP)
Funding ID 095874/2/11/2 
Organisation Wellcome Trust 
Sector Charity/Non Profit
Country United Kingdom
Start 04/2012 
End 03/2015
 
Description Project Grant
Amount £240,000 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 06/2011 
End 05/2013
 
Description Project grant
Amount £2,000,000 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start  
 
Description Research Fellowship Programme
Amount SFr. 280,000 (CHF)
Organisation F. Hoffmann-La Roche AG 
Department Roche Diagnostics
Sector Private
Country Global
Start  
 
Description Research Methods Fellowship
Amount £91,000 (GBP)
Funding ID MET-2012-18 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 10/2012 
End 09/2014
 
Description Research Methods Fellowship
Amount £91,000 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 10/2013 
End 09/2015
 
Description Research Methods Fellowship
Amount £91,000 (GBP)
Funding ID MET-2012-12-27 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 03/2013 
End 03/2015
 
Description School for Primary Care Research Capacity
Amount £42,251 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 07/2014 
End 06/2015
 
Description The Research for Patient Benefit Programme
Amount £250,000 (GBP)
Organisation National Institute for Health Research 
Department Research for Patient Benefit
Sector Public
Country United Kingdom
Start 01/2010 
End 01/2012
 
Title Joiner 
Description Novel methods for joint modelling combined repeated measurements and event-time data, or informative drop-out were developed and published. These methods were exploited fully in substantive applications over a range of medical settings including epilepsy treatment, cardio-thoracic surgery and renal medicine. Software for the new methods was developed as an add-on package ("JoineR") within the R environment so as to make the software freely available to researchers. 
Type Of Material Improvements to research infrastructure 
Year Produced 2009 
Provided To Others? Yes  
Impact Joint modelling approach provided the clinical research community with an awareness of the potential problems commonly occur in clinical and observational studies and the inefficiency of use of simple statistical methods which are often failing to take account of informative dropout during the intended follow-up period. Thereby we have improved current practice in the analysis of the complex longitudinal data structures that commonly arise in clinical and public health research. 
 
Title ORBIT 
Description Outcome reporting bias is an under-recognised problem which can affect the inference in a systematic review. Reviewers should address explicitly the issue of missing outcome data in order for reviews to be considered a reliable source of evidence about healthcare practice. We have proposed an outcome matrix be used for this purpose alongside the development of a new classification system for the assessment of selective outcome reporting. 
Type Of Material Improvements to research infrastructure 
Year Produced 2010 
Provided To Others? Yes  
Impact The main findings were that a third of Cochrane reviews contained at least one trial with high outcome reporting bias (ORB) suspicion for the review primary outcome. Considering meta-analyses with a statistically significant result only, just under a fifth were not robust to ORB and over a quarter would have overestimated the treatment effect by 20% or more. We found ORB to be an under-recognised problem which affects the inference in a substantial proportion of Cochrane reviews. 
 
Description COMET Initiative 
Organisation Medical Research Council (MRC)
Department MRC All-Ireland Hub for Trials Methodology Research
Country United Kingdom 
Sector Public 
PI Contribution Led in the set up of the COMET Initiative with collaboration from colleagues in the All-Ireland HTMR, Conduct HTMR and University of Oxford. A joint grant application was made by the four collaborating centres to the MRC Network of Hubs for Trials Methodology Research and £50000 was awarded.
Collaborator Contribution Member of the COMET Initiative Management GroupMember of the COMET Initiative Management GroupMember of the COMET Initiative Management Group
Impact COMET Initiative Launch meeting, Liverpool 2010 2nd meeting of the COMET Initiative, Bristol 2011 Design and launch of the COMET Initiative website 2011 COMET Initiative blog series established with the BMJ Advice on core outcomes informed NICE 2011 epilepsy guidelines COMET featured on the homepage of the NIHR website Addition to NIHR HTA application form, explicitly referencing importance of core outcomes sets, the COMET Initiative and website
Start Year 2010
 
Description COMET Initiative 
Organisation Medical Research Council (MRC)
Department MRC ConDuCT Trials Methodology Hub
Country United Kingdom 
Sector Public 
PI Contribution Led in the set up of the COMET Initiative with collaboration from colleagues in the All-Ireland HTMR, Conduct HTMR and University of Oxford. A joint grant application was made by the four collaborating centres to the MRC Network of Hubs for Trials Methodology Research and £50000 was awarded.
Collaborator Contribution Member of the COMET Initiative Management GroupMember of the COMET Initiative Management GroupMember of the COMET Initiative Management Group
Impact COMET Initiative Launch meeting, Liverpool 2010 2nd meeting of the COMET Initiative, Bristol 2011 Design and launch of the COMET Initiative website 2011 COMET Initiative blog series established with the BMJ Advice on core outcomes informed NICE 2011 epilepsy guidelines COMET featured on the homepage of the NIHR website Addition to NIHR HTA application form, explicitly referencing importance of core outcomes sets, the COMET Initiative and website
Start Year 2010
 
Description COMET Initiative 
Organisation University of Oxford
Country United Kingdom 
Sector Academic/University 
PI Contribution Led in the set up of the COMET Initiative with collaboration from colleagues in the All-Ireland HTMR, Conduct HTMR and University of Oxford. A joint grant application was made by the four collaborating centres to the MRC Network of Hubs for Trials Methodology Research and £50000 was awarded.
Collaborator Contribution Member of the COMET Initiative Management GroupMember of the COMET Initiative Management GroupMember of the COMET Initiative Management Group
Impact COMET Initiative Launch meeting, Liverpool 2010 2nd meeting of the COMET Initiative, Bristol 2011 Design and launch of the COMET Initiative website 2011 COMET Initiative blog series established with the BMJ Advice on core outcomes informed NICE 2011 epilepsy guidelines COMET featured on the homepage of the NIHR website Addition to NIHR HTA application form, explicitly referencing importance of core outcomes sets, the COMET Initiative and website
Start Year 2010
 
Title COMET Website 
Description The COMET website hosts a searchable database. The website is currently live. The website was developed using funding awarded by the MRC Network of Hubs for Trials Methodology Research. 
Type Support Tool - For Fundamental Research
Current Stage Of Development Small-scale adoption
Year Development Stage Completed 2011
Development Status Under active development/distribution
Impact From its launch in August 2011 to date the website has had 14,874 database searches and 53,749 unique visitors from 174 countries. 
URL http://www.comet-initiative.org/
 
Title DIRUM website 
Description The DIRUM (Database of Instruments for Resource Use Measurement) website provides a practical, open-access database of resource-use questionnaires for use by trial health economists. The website is currently live. The website received funding from the MRC Network of Hubs for Trials Methodology Research. 
Type Support Tool - For Fundamental Research
Current Stage Of Development Small-scale adoption
Year Development Stage Completed 2011
Development Status Under active development/distribution
Impact Since its launch on 6 June 2011 to 14 November 2011 the website has had 1971 visits and 440 downloads. 
 
Title Statistical software 
Description Shareware software to implement methods developed. 
Type Support Tool - For Fundamental Research
Current Stage Of Development Small-scale adoption
Year Development Stage Completed 2009
Development Status Under active development/distribution
Impact Request for access from researchers. 
 
Description COMET talk, 2nd UK Clinical Trials Methodology Conference, Edinburgh, 2013 (LG) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Abstract accepted to present systematic review

Not known yet.
Year(s) Of Engagement Activity 2013
 
Description COMET talk, ECRIN 2013 PW 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact The aims and progress of the COMET Initiative were described

The talk raised awareness amongst international clinical research groups
Year(s) Of Engagement Activity 2013
 
Description COMET talk, EQUATOR 2012 PW 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact The aims and progress of the COMET Initiative were described

The talk raised awareness amongst international clinical research groups
Year(s) Of Engagement Activity 2012
 
Description COMET talk, Exploiting Existing Data for Health Research" 4th International Conference hosted by the Scottish Health Informatics Programme in association with the four UK Ehealth Informatics Research Centres, St Andrews, 2013 (PW) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Abstract accepted for oral presentation.

Opened up a new area of interest.
Year(s) Of Engagement Activity 2013
 
Description COMET talk, HSRN Symposium 2013, UK (PW) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Abstract selected for oral presentation.

Not known yet.
Year(s) Of Engagement Activity 2013
 
Description COMET talk, InFACT/ISF Outcome Measures Colloquium, Amsterdam, 2013 (PW) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Talk delivered and active participation in workshop.

Ongoing collaboration.
Year(s) Of Engagement Activity 2013
 
Description COMET talk, Network of Hubs for Trials Methodology Annual Meeting, Oxford, 2013 (LG) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Talk delivered. Question and answer session.

Slides of presentation shared.
Year(s) Of Engagement Activity 2013
 
Description COMET talk, PSI Annual conference, Glasgow, 2013 (PW) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Delivered to wider audience.

Talk well received, audience participation and questions. Advice provided.
Year(s) Of Engagement Activity 2013
 
Description COMET talk, Workshop on the methods for benefit-risk analysis in drug regulation and health technology assessment, Bangor, Jan 2013 (PW) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Delivered to specialist audience, increased awareness and interest in the COMET Initiative.

Further discussions.
Year(s) Of Engagement Activity 2013
 
Description COMET workshop, 21st Cochrane Colloquium, Canada, 2013 (PW) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Workshop Facilitator
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Interactive workshop delivered, attended by 25 individuals.

Feedback sought from systematic reviewers about suitability of workshop for this audience.
Year(s) Of Engagement Activity 2013
 
Description COMET workshop, Kyoto, Japan, 2013 (PW, MC and LG) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Workshop Facilitator
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact 2 day workshop delivered, attended by approximately 100 individuals from all over Japan.

Introduced Japanese researchers to the COMET Initiative and the idea of core outcome sets. Recieved excellent feedback and was very well received. On-going discussion regarding possibility of future collaboration.
Year(s) Of Engagement Activity 2013
 
Description COMET workshop, NICE 2011 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact A COMET workshop was delivered at a National Institute for Health and Clinical Excellence (NICE) National Collaborating Centres (NCC) Technical Meeting. This was attended by over 40 participants involved in the NICE guideline development process. The objectives of the workshop were to identify problems with outcomes in clinical trials and the subsequent impact for systematic reviews/reviewers and guidelines/guideline developers, and to consider core outcome sets as a solution to these problems. The workshop included formal presentation, group exercise and discussion.

We were approached by the programme manager for the Patient and Public Involvement programme at NICE, who runs workshops with patients, who asked if they could use one of the examples from the group exercise in their workshops with patients, as it would be a great way of getting patients to think about outcomes.
Year(s) Of Engagement Activity 2011
 
Description Cochrane Conference presentations 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Geographic Reach International
Primary Audience Participants in your research and patient groups
Results and Impact Consumers attended workshop.

Well received.
Year(s) Of Engagement Activity 2008,2009,2010,2011
 
Description DIRUM workshop 2011 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Type Of Presentation Workshop Facilitator
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact On 19th October 2011 a workshop was held in Birmingham where 40 people, mostly academic, contributed to discussions on methods for the collection of resource use data.

Group and panel discussions resulted in a short listing of priority areas for defining a research agenda.
Year(s) Of Engagement Activity 2011
 
Description Grand Round 2011 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach Local
Primary Audience Health professionals
Results and Impact Presented findings from RECRUIT on parents' and practitioners' perspectives on recruitment to children's clinical trials at Alder Hey Children's Hospital, May 2011.

Discussions following presentation led to funding application
Year(s) Of Engagement Activity 2011
 
Description International Clinical Trials Day 2012 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Invited to speak about the COMET Initiative as part of the European Clinical Research Infrastructure Network's 2012 International Clinical Trials' Day Celebration in Dublin on 18th May 2012 http://www.ecrin.org/index.php?id=34

Participants at the meeting asked for details of the next meeting of the COMET Initiative.
Year(s) Of Engagement Activity 2012
 
Description JLA teleconference 2012 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact A teleconference was held following a request for advice from NICE and JLA about COMET and methods for core outcome set development.

Agreement to work in partnership.
Year(s) Of Engagement Activity 2012
 
Description JoineR Workshop 2013, Newcastle RKD 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation Workshop Facilitator
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact 13 participants. The workshop was interactive throughout where participants discuss applying the methods in their clinical data, and had hands-on experience in using the software JoineR.

The workshop has received very positive feedback. All participants considered use of joint modelling in their future research and improved their understanding of the relevance of joint modelling ideas to substantive clinical research.
Year(s) Of Engagement Activity 2013
 
Description Joint modelling talk, Budapest 2013 RKD 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact 30-40 participants. The talk was followed by a lively discussion where participants discussed applying the methods in their clinical and biolomedical research.

Requests for the software JoineR.
Year(s) Of Engagement Activity 2013
 
Description Joint modelling talk, London 2013 RKD 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact 50-60 participants. The talk was followed by a lively discussion where participants discussed applying the methods in their clinical and biolomedical research.

Several participants approached to discuss their projects involving longitudinal data and requested the software JoineR.
Year(s) Of Engagement Activity 2013
 
Description Local COMET meeting 2012 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Type Of Presentation Workshop Facilitator
Geographic Reach Local
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact A meeting was held in Liverpool on 17th January 2012 for those with interest in core outcome sets development projects that are being led from Liverpool. Individuals discussed their projects and shared their expertise and ideas.

Some important methodological considerations were raised, including the necessity to define the scope of each core outcome set as each will be unique, the importance of the questions you ask to patients and clinicians and the differences in methods being used.
Year(s) Of Engagement Activity 2012
 
Description NRES training day 2011 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact Presented findings from RECRUIT and CACE on children and young people's perspectives on recruitment to clinical trials at National Research Ethics Service Training Day, November 2011.

Aimed to help ethics committee members understand what is (and is not) important to young people when they are approached about entering a clinical trial
Year(s) Of Engagement Activity 2011
 
Description ORBIT workshop / presentations 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Geographic Reach International
Primary Audience Health professionals
Results and Impact Members of the research team have presented the findings at several national and international research meetings. During the project, the ORBIT workshop was developed and delivered, usually by three of the team, at several Cochrane meetings (Dublin, Freiburg, Edinburgh, Halifax, Singapore). The workshop includes a small group exercise, in which participants read trial reports and use our classification system to determine the likelihood of outcome reporting bias. The examples we use are chosen to illustrate a variety of classifications and are taken from systematic reviews where we have obtained the information from the trialist themselves. The workshop also demonstrates how our classification of the risk of outcome reporting bias helps to assess the related dimension in the new 'Risk of bias' tool being used by the Cochrane Collaboration. The presentations have focussed on both the prevalence and impact of outcome reporting bias in a large unselected cohort of Cochrane systematic reviews (see BMJ publication) and interviews with trialists to understand the reasons for discrepancies between outcomes specified in the trial protocol and those reported in the study publication (submitted to BMJ).

The feedback evaluations received from the most recent workshop have been extremely positive with all participants finding the workshop useful, and 60-75% finding it very useful. Recently, the Cochrane Bias Methods Group designated this a 'core' workshop which enabled one of our team to attend the Cochrane Colloquium in Singapore for free.
Year(s) Of Engagement Activity 2006,2007,2008,2009
 
Description PACT workshop, Manchester 2014 (PB) 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact 20 participants knowledge exchange and identification of future methodological research to improve patient experience of trials

Links with INVOLVE
Year(s) Of Engagement Activity 2014
 
Description RSS meeting 2012 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Approx 50 people from a range of institutions attended a talk on a joint modelling approach to determine the predictive accuracy of a longitudinal biomarker. The talk was followed by a lively discussion where participants discussed applying the methods in their clinical data/settings

Participants requested the software JoineR
Year(s) Of Engagement Activity 2012
 
Description School visit - Wirral 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Schools
Results and Impact A talk about clinical trials

Teacher fedback that it was well received by students.
Year(s) Of Engagement Activity 2009
 
Description Talk, 16th Annual J&J Pharma Statistics Conference (TJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Wider dissemination of work


Discussions about implementation of method with Janssen Pharmaceutica
Year(s) Of Engagement Activity 2014
 
Description Talk, 35th Conference of the International Society for Clinical Biostatistics (TJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Wider dissemination of work


Discussions about implementation of method with a CRO
Year(s) Of Engagement Activity 2014
 
Description Talk, 35th Conference of the International Society for Clinical Biostatistics 2014 (AC) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Wider dissemination of work


None at present
Year(s) Of Engagement Activity 2014
 
Description Talk, 35th Conference of the International Society for Clinical Biostatistics 2014 (LH) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Health professionals
Results and Impact Wider dissemination of work

None
Year(s) Of Engagement Activity 2014
 
Description Talk, 35th Conference of the International Society for Clinical Biostatistics 2014 (WYY) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Wider dissemination of work


None at present
Year(s) Of Engagement Activity 2014
 
Description Talk, 36th Society for Clinical Trials Conference 2015 (TJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Raising profile of Hub; Dissemination of hub research


NA
Year(s) Of Engagement Activity 2015
 
Description Talk, 5th Annual Summit for Clinical Ops Executives 2014 (AHM) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Dicussion

No notable impacts
Year(s) Of Engagement Activity 2014
 
Description Talk, Barcelona Biomed 2012 LH 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Communicated research to broad audience of statisticians and received useful feedback from the audience

Not measurable yet
Year(s) Of Engagement Activity 2012
 
Description Talk, Berlin 2011 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Medical statisticians attended a talk presenting the results of methodological research.

Methods have now been implemented in open-source R package upon request from audience.
Year(s) Of Engagement Activity 2011
 
Description Talk, Birmimgham 2013 RKD 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact 150 participants. The talk was followed by a lively discussion.

Several participants approached to discuss their projects involving longitudinal biomarker data.
Year(s) Of Engagement Activity 2013
 
Description Talk, Cambridge 2012 LH 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Communicated research to a wider audience

Subsequently approached to share presentation slides with members of audience
Year(s) Of Engagement Activity 2012
 
Description Talk, EMA 2012 LH 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach Local
Primary Audience Policymakers/politicians
Results and Impact Communicated research findings to PDCO and obtained their feedback on project

Not measurable yet
Year(s) Of Engagement Activity 2012
 
Description Talk, Florence 2014 (TJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Wider dissemination of work

None at present
Year(s) Of Engagement Activity 2014
 
Description Talk, Germany 2014 (TJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Wider dissemination of work

None at present
Year(s) Of Engagement Activity 2014
 
Description Talk, Heidelberg 2012 DM 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact The talk contained some mathematical results concerning simultaneous confidence intervals for a multidimensional parameter, e.g., the treatment effect sizes in a multi-arm clinical study

New methodology for analyzing clinical trials involving multiple comparisons
Year(s) Of Engagement Activity 2012
 
Description Talk, Heidelberg 2012 LH 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Communicated research to a wider audience

Not yet measurable
Year(s) Of Engagement Activity 2012
 
Description Talk, Institute Gustave-Roussy 2014 (LH) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Health professionals
Results and Impact Wider dissemination of work

Developed a collaboration with Dr Marie-Cecile Le Deley which has culminated in joint supervision of a PhD student who started in October 2014 and is developing novel Bayesian designs for clinical trials in rare cancers
Year(s) Of Engagement Activity 2014
 
Description Talk, Institute of Population Health Postgraduate showcase 2014 (AHM) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Discussion

Not aware of any notable impacts
Year(s) Of Engagement Activity 2014
 
Description Talk, Liverpool 2011 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact Talk to a broad audience of basic researchers, clinicians, policy makers, industry and the public on a novel early phase trial design.

Novel early phase trial design is currently being implemented in a CRUK trial.
Year(s) Of Engagement Activity 2011
 
Description Talk, London 2012 JW 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact The talk presented early ideas on eliciting opinion which, after refinement and improvement, has led to the methodology implemented for the MYPAN trial

The meeting led to exchange of ideas and promotion of the Bayesian approach. There has been subsequent interest in using the methodology, but attribution to any particular meeting is difficult.
Year(s) Of Engagement Activity 2012
 
Description Talk, MRC/NIHR Methods Fellows Meeting 2014 (RE) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Discussion with audience about MRC career's options, and stratified medicine research


Collaboration with Newcastle around methodology work
Year(s) Of Engagement Activity 2014
 
Description Talk, Manchester 2012 BY 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Health professionals
Results and Impact Practitioners are concerned about the burden posed to families by inviting children to participate in clinical trials but families report that they are happy to be approached about clinical trials

Not known
Year(s) Of Engagement Activity 2012
 
Description Talk, Manchester 2012 KP 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Postgraduate students
Results and Impact This was a national talk for all MRC hub associated PhD students allowing communication between PhD students between different institutions

The talk was well received and allowed communication between PhD students between different institutions.
Year(s) Of Engagement Activity 2012
 
Description Talk, Manchester 2014 (PB) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Health professionals
Results and Impact Education and training

Change in practice in attendants
Year(s) Of Engagement Activity 2014
 
Description Talk, Mini Symposium on alternative methods for dose-finding and dose-ranging trials 2015 (TJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Raising profile of Hub; Dissemination of hub research


Has led to Merck adopting a model based approach to dose finding for the first time
Year(s) Of Engagement Activity 2015
 
Description Talk, Neonatal and Midwifery Collaboration on Research Delivery meeting Birmingham 2015 (BY) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Health professionals
Results and Impact Dissemination of Hub research particularly RECRUIT study
Year(s) Of Engagement Activity 2015
 
Description Talk, Newcastle 2012 TJ 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact It has allowed wider dissemination of the work

None known of
Year(s) Of Engagement Activity 2012
 
Description Talk, Norway 2012 KP 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact This was an international talk where the audience were International Biostatisticians from both academia and industry

The talk was well received and some connections were made with industry professionals who offered advice about practical considerations
Year(s) Of Engagement Activity 2012
 
Description Talk, Novartis internal statistics seminar series 2014 (SS) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact Wider dissemination of work


None
Year(s) Of Engagement Activity 2014
 
Description Talk, Oslo 2012 TJ 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact It has allowed wider dissemination of the work

Some discussions on using our methods in different studies
Year(s) Of Engagement Activity 2012
 
Description Talk, PSI 2012 TJ 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact It has allowed wider dissemination of the work

Some discussions on using our methods in different studies
Year(s) Of Engagement Activity 2012
 
Description Talk, RSS 2012 TJ 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact It has allowed wider dissemination of the work

Some discussion on using our methods in a study
Year(s) Of Engagement Activity 2012
 
Description Talk, SMi Conference on Adaptive designs in Clinical Trials 2014 (LH) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Wider dissemination of work to the pharmaceutical industry

None
Year(s) Of Engagement Activity 2014
 
Description Talk, Southampton 2012 DM 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact The talk contained some mathematical results concerning simultaneous confidence intervals for a multidimensional parameter, e.g., the treatment effect sizes in a multi-arm clinical study

New methodology for analyzing clinical trials involving multiple comparisons
Year(s) Of Engagement Activity 2012
 
Description Talk, Southampton 2012 KP 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Postgraduate students
Results and Impact This was a national talk for all PhD students in Statistics, including some participants from Europe.

This talk included students from outside of the medical statistics background to understand different contexts for methodology and input into the methodological aspects was offered.
Year(s) Of Engagement Activity 2012
 
Description Talk, Symposium on Early Phase Dose Finding Methodology 2015 (TJ) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Raising profile of Hub; Dissemination of hub research


NA
Year(s) Of Engagement Activity 2015
 
Description Talk, Tokyo 2012 DH 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact The presentation included an overview of the methods of health technology assessment of novel genetic predictors of drug response.

The intention was to stimulate UK/Japan collaborative research in the area of personalised medicine
Year(s) Of Engagement Activity 2012
 
Description Talk, UK 2013 TJ 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact It has allowed wider dissemination of the work

Some specific queries about implementing our methods
Year(s) Of Engagement Activity 2013
 
Description Talk, Wales 2012 DH 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Health professionals
Results and Impact The presentation concerned the cost-effectiveness of dabigatran, rivaroxaban, apixaban and warfarin for the management of patients with atrial fibrillation

The research informed the development of the advice in Wales on the role of the new oral anticoagulants, and was submitted for consideration by NICE, of the cost-effectiveness of dabigatran
Year(s) Of Engagement Activity 2012
 
Description Talk, Warwick 2012 TJ 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact It has allowed wider dissemination of the work

Joint research with the Warwick group
Year(s) Of Engagement Activity 2012
 
Description Visit to Vienna 2011 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact A visit was made to the Medical University in Vienna to work with experts in the field of adaptive designs.

Many opportunities for collaborations and joint work were identified and the first joint project is nearing its finalisation.
Year(s) Of Engagement Activity 2011
 
Description Workshop, Bangor 2013 DH 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation Workshop Facilitator
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact The aim of the workshop was to develop a research agenda on the assessment of benefits in relation to harm in the context of health technology assessment

Draft paper in preparation
Year(s) Of Engagement Activity 2013
 
Description Workshop, Canada 2012 BY 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation Workshop Facilitator
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Identification of key points of difference in models and areas for future research

Lead to an idea for a paper, which has been drafted (by a workshop participant) and is expected to be submitted soon
Year(s) Of Engagement Activity 2012
 
Description Workshop, Liverpool 2012 CTS 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation Workshop Facilitator
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact 50 delegates with 34 registered CTUs, 6 hubs and the MHRA represented attended a workshop on monitoring in Liverpool.

As a result of the workshop an invitation was received to present a workshop at the Trial Managers Network conference. Since the workshop we have received a request for one of the CTUs to visit the Clinical Trials Research Centre to discuss monitoring practice further. Another CTU has requested further information about developing central statistical monitoring methods. A further CTU has requested information on the risk assessment approach used at CTRC. Another CTU has visited the CTRC to discuss monitoring approaches.
Year(s) Of Engagement Activity 2012
 
Description Workshop, Manchester 2012 PW 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation Workshop Facilitator
Geographic Reach Regional
Primary Audience Health professionals
Results and Impact 38 leading trialists attended a workshop and explored greater clinical collaboration on methodological issues in trials

Following the meeting suggestions were received from participants on how clinical engagement can be increased, in particular engagement with ACFs.
Year(s) Of Engagement Activity 2012
 
Description Workshop, Nuffield Council on Bioethics 2014 (BY) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Health professionals
Results and Impact Discussion of wide range of ethical, methodological, PPI and practical issues related to children's research worldwide

Nuffield Council report due April 2015
Year(s) Of Engagement Activity 2014