Innovating in Large-Scale Epidemiology

Lead Research Organisation: Medical Research Council

Abstract

Effective healthcare is critically dependent on reliable evidence from high-quality clinical trials and observational studies. Over the last few decades we have pioneered the use of streamlined designs – for example, large randomised trials involving tens of thousands of participants, and even larger observational studies, such as the UK Biobank and China Kadoorie Biobank, each involving over 0.5 million people. Such studies need to be carefully designed to provide reliable answers and streamlined so that the study can be conducted, analysed and reported within the available time and resources.
Many of these advances are possible by the close working of our scientists with our IT experts and these developments have transformed how large scale studies are conducted. For example, we pioneered the use of simple to use touch-screen questionnaires in large studies and developed sophisticated tools to review any adverse events of drugs being evaluated in a clinical trial. Our current and future work is also extending the scope and range of linking to routine health records for the long-term follow-up of our research participants.
The next 5 years will see significant expansion in this work, and we will play a central role in Oxford University’s major initiative to develop a “Big Data Institute”.

Technical Summary

Effective healthcare is critically dependent on reliable evidence from high quality clinical trials and observational studies. However, there is widespread concern that rising costs, driven by cumbersome study design and burdensome research regulation has made such studies substantially more difficult and expensive to conduct.
This programme aims to promote and deploy the streamlined design, conduct and analysis of high quality large-scale clinical trials and observational studies; maximize opportunities for effective and efficient epidemiological research provided by large-scale studies; and encourage proportionate, efficient and coordinated research regulation.
Over the last few decades we have pioneered the use of streamlined designs – for example, large randomised trials involving tens of thousands of participants, and even larger observational studies, such as the UK Biobank and China Kadoorie Biobank, each involving over 0.5 million people.
The next 5 years will see significant expansion in this work, and we will play a central role in Oxford University’s major initiative to develop a “Big Data Institute”. The emerging field of Big Data offers the potential for seismic changes in the scale (breadth, depth and duration) and efficiency (data accumulation, storage, processing and dissemination) of clinical studies, enhancing our expertise in recruiting, phenotyping and assessing outcomes in very large cohorts.
In order to maximise the scientific and public health returns from these new opportunities, it will be important to design systems and approaches that are focused on the key drivers of study quality and essential to ensure that their appropriate use is unencumbered by disproportionate regulatory or bureaucratic obstacles. In parallel, we will play a leading role in tackling obstacles to high quality research caused by inappropriate regulation.

Publications


10 25 50
Armitage J (2008) The impact of privacy and confidentiality laws on the conduct of clinical trials. in Clinical trials (London, England)
Boylan JF (2011) Randomised controlled trials: important but overrated? in The journal of the Royal College of Physicians of Edinburgh
 
Description Academy of Medical Sciences Working Group on Health Research Governance
Geographic Reach National 
Policy Influence Type Participation in a national consultation
 
Description Briefing for BHF input to UK government Caldicott Review of Data Security
Geographic Reach National 
Policy Influence Type Gave evidence to a government review
 
Description CTTI Quality-by-Design Co-lead
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Comments to MRC on brefing for MISG Information Governance group for routine healthcare data
Geographic Reach National 
Policy Influence Type Gave evidence to a government review
 
Description Department of Health consultation: protecting personal health and care data
Geographic Reach National 
Policy Influence Type Participation in a national consultation
 
Description Develop residential short-training programme on doing streamlined randomised trials
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
 
Description EMA Policy workshops
Geographic Reach Asia 
Policy Influence Type Participation in advisory committee
 
Description ESC Advisor for new EU Clinical Trial Regulation
Geographic Reach Europe 
Policy Influence Type Influenced training of practitioners or researchers
Impact significant chapters in ICH guideline development
 
Description ESC Taskforce: Improving patient safety by improving clinical trials
Geographic Reach Europe 
Policy Influence Type Influenced training of practitioners or researchers
 
Description FDA Guidance Review: endpoints in CVD trials
Geographic Reach North America 
Policy Influence Type Membership of a guidance committee
 
Description FDA Revised Guidance (August 2013): Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring
Geographic Reach North America 
Policy Influence Type Implementation circular/rapid advice/letter to e.g. Ministry of Health
Impact Revised guidance from FDA on a risk-based approach to monitoring directly arose from Clinical Trials Transformation Initiative (CTTI).
URL http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM269919.pdf
 
Description FDA/NKF Guideline review: earlier endpoints for chronic kidney disease trials
Geographic Reach North America 
Policy Influence Type Membership of a guidance committee
 
Description Letter to Lead MEP from UKCRC Directors on draft EU Clinical Trial Regulation
Geographic Reach Asia 
Policy Influence Type Gave evidence to a government review
 
Description Letter to Lead MEP on draft EU Clinical Trial Regulation
Geographic Reach Asia 
Policy Influence Type Gave evidence to a government review
 
Description Letter to MHRA on draft EU Clinical Trial Regulation
Geographic Reach Asia 
Policy Influence Type Gave evidence to a government review
 
Description MHRA 5-year strategic review
Geographic Reach National 
Policy Influence Type Participation in a national consultation
 
Description MHRA Good Clinical Practice Handbook 2012
Geographic Reach National 
Policy Influence Type Implementation circular/rapid advice/letter to e.g. Ministry of Health
 
Description MRC/DH/MHRA Joint Project on Risk Stratificatrion
Geographic Reach National 
Policy Influence Type Participation in a national consultation
 
Description Meeting with funders MRC, Wellcome Trust, CRUK, AMS to discuss problems with draft EU Clinical Trial Regulation
Geographic Reach Asia 
Policy Influence Type Participation in advisory committee
 
Description Member of Arthritis Research UK Review of Biobanking
Geographic Reach National 
Policy Influence Type Participation in advisory committee
 
Description NIHR Carbon Reduction Guidelines
Geographic Reach National 
Policy Influence Type Participation in advisory committee
 
Description Nuffield Council for Biothics - Big Data
Geographic Reach National 
Policy Influence Type Participation in a national consultation
 
Description Participation in UKCRC WG and report Efficient Trial Conduct report
Geographic Reach National 
Policy Influence Type Citation in other policy documents
 
Description Partner with Sense About Science to start campaign to make it much easier to do randomised trials
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
 
Description REsponse to UKCRC on EudraCT End of Trial Reporting problems
Geographic Reach Europe 
Policy Influence Type Gave evidence to a government review
 
Description Response to "How does society use evidence........." AMS consultation
Geographic Reach National 
Policy Influence Type Gave evidence to a government review
 
Description Response to AMS on initial draft of HRA policy framework for health and social care research
Geographic Reach National 
Policy Influence Type Gave evidence to a government review
 
Description Response to Academy of Medical Sciences to the Health Research Authority (HRA) consultation on the UK Health Policy Framework
Geographic Reach National 
Policy Influence Type Gave evidence to a government review
Impact HRA policy framework supports conduct of high-quality across all of the UK - number of suggestions made to improve policy
 
Description Response to EMA & ICH on ICH's proposed update to ICH-GCP guideline
Geographic Reach Multiple continents/international 
Policy Influence Type Gave evidence to a government review
 
Description US Institute of Medicine Discussion Framework for Clinical Trial Data Sharing
Geographic Reach North America 
Policy Influence Type Participation in a national consultation
 
Description Wellcome Trust Clinical Trial Data Access Survey
Geographic Reach National 
Policy Influence Type Participation in a national consultation
 
Description Working with local collaborators in Beijing to improve clinical trial regulation in China
Geographic Reach Asia 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Written briefing for Wellcome Trust to give evidence to Health Select Committee inquiry into use of NHS records for research
Geographic Reach National 
Policy Influence Type Gave evidence to a government review
 
Description Written comments on HSCIC draft 5-year strategy
Geographic Reach National 
Policy Influence Type Gave evidence to a government review
 
Description Written response ONS Approved Researcher Consultation
Geographic Reach National 
Policy Influence Type Gave evidence to a government review
 
Description Written response to AMS on DH consultation: protecting personal health and care data
Geographic Reach National 
Policy Influence Type Gave evidence to a government review
 
Description Written response to CTTI Recommendations on the use if central IRBs
Geographic Reach Multiple continents/international 
Policy Influence Type Gave evidence to a government review
 
Description Written response to FDA consultation: Safety Assessment for IND Safety Reporting - Draft Guidance for Industry
Geographic Reach North America 
Policy Influence Type Gave evidence to a government review
Impact To improve the efficiency of safety reporting for trials of INDs
 
Description Written response to HRA Consent to Simple Trials Consultation
Geographic Reach National 
Policy Influence Type Gave evidence to a government review
 
Description Written response to HRA information governance review led by Dr mark Taylor, Chair CAG
Geographic Reach National 
Policy Influence Type Gave evidence to a government review
 
Description Written response to HSCIC Customer Survey - Requirements for Secure Data Access
Geographic Reach National 
Policy Influence Type Gave evidence to a government review
 
Description Written response to HSCIC Feedback on the draft terms of reference for the proposed new Independent Group Advising on the Release of Data (IGARD)
Geographic Reach National 
Policy Influence Type Gave evidence to a government review
 
Description Written response to UKCRC CTUs Network on draft proposals for good practice principles for sharing IPD from publicly funded clinical trials
Geographic Reach National 
Policy Influence Type Gave evidence to a government review
 
Description Written response to UKCRC on WHO consultation on publication of clinical trial results
Geographic Reach Multiple continents/international 
Policy Influence Type Gave evidence to a government review
 
Description Written response to Wellcome Trust Clinical Trial Data Access Survey
Geographic Reach National 
Policy Influence Type Gave evidence to a government review
 
Description Assessment Centre IT systems
Amount £4,500,000 (GBP)
Organisation UK Biobank 
Sector Charity/Non Profit
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start  
 
Description Biomedical Research Centre: Clinical Informatics and Big Data
Amount £4,600,000 (GBP)
Organisation National Institute for Health Research (NIHR) 
Sector Public
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start  
 
Description Capital grant Oxford University Big Data Institute
Amount £1,000,000 (GBP)
Organisation British Heart Foundation (BHF) 
Sector Charity/Non Profit
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start 11/2013 
End 11/2015
 
Description Capital grant Oxford University Big Data Institute
Amount £1,000,000 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start 04/2014 
End 03/2015
 
Description HPS3/TIMI55-REVEAL trial
Amount £106,000,000 (GBP)
Organisation Merck & Co., Inc. (MSD) 
Department Merck Sharp and Dohme Ltd
Sector Private
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start  
 
Description Research Excellence Award (Sensible Guidelines)
Amount £10,000 (GBP)
Organisation British Heart Foundation (BHF) 
Sector Charity/Non Profit
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start 04/2009 
End 03/2010
 
Description Research grant
Amount £16,000 (GBP)
Organisation Medical Research Council (MRC) 
Department MRC Hubs for Trial Methodology Research
Sector Public
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start  
 
Description Research grant
Amount £6,000,000 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start  
 
Description Research grant
Amount £17,000 (GBP)
Organisation Medical Research Council (MRC) 
Department MRC Hubs for Trial Methodology Research
Sector Public
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start  
 
Description Research grant
Amount £3,663,124 (GBP)
Organisation UK Biobank 
Sector Charity/Non Profit
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start  
 
Description Research seed grant
Amount £236,636 (GBP)
Organisation Li Ka Shing Foundation 
Sector Charity/Non Profit
Country Hong Kong, Special Administrative Region of China
Start 04/2014 
End 04/2015
 
Description UK infrastructure for large-scale genomics research
Amount £23,988,316 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start  
 
Description Clinical Trials Transformation Initiative CTTI 
Organisation Duke University
Department Duke University Medical Centre
Country United States of America 
Sector Academic/University 
PI Contribution Member of steering committee. Co-chair Trial Monitoring Project (2008-12), Co-chair Quality by Design Project (2012-2016); Membership of Antibacterial Drug Development Working Group (2013-2014) Co-chair Mobile Trials Novel Endpoints Project (2016-); Contributions to projects related to efficient trial design, delivery and analysis
Collaborator Contribution Multi-stakeholder group to to identify and promote practices that will increase the quality and efficiency of clinical trials.
Impact See publications & regulators (FDA and EMA) have issued revised guidance on risk-based monitoring,
Start Year 2008
 
Description Clinical Trials Transformation Initiative CTTI 
Organisation Food and Drug Administration (FDA)
Country United States of America 
Sector Public 
PI Contribution Member of steering committee. Co-chair Trial Monitoring Project (2008-12), Co-chair Quality by Design Project (2012-2016); Membership of Antibacterial Drug Development Working Group (2013-2014) Co-chair Mobile Trials Novel Endpoints Project (2016-); Contributions to projects related to efficient trial design, delivery and analysis
Collaborator Contribution Multi-stakeholder group to to identify and promote practices that will increase the quality and efficiency of clinical trials.
Impact See publications & regulators (FDA and EMA) have issued revised guidance on risk-based monitoring,
Start Year 2008
 
Description MoreTrials Campaign 
Organisation James Lind Alliance
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Charity/Non Profit 
PI Contribution CTSU set up and leads this new campaign in partnership with the charity, Sense About Science, London. The aim is to remove regulatory and other barriers to the conduct of high-quality randomised trials. Currently, more than 100 trialists from 22 countries along with 5 research organisations have signed up to support the campaign.
Collaborator Contribution Collaborations are helping to promote the campaign and helping to write new guidelines for the conduct of high-quality randomised trials.
Impact A letter prepared by CTSU has been signed by more than 100 trialists in 22 countries and 5 research organisations and sent to the European Medicines Agency, EMA pointing out the fundamental problems with ICH-GCP, the structural problems with ICH itself and the failure of ICH's recent proposed update to address these problems.
Start Year 2015
 
Description MoreTrials Campaign 
Organisation Sense about Science
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Charity/Non Profit 
PI Contribution CTSU set up and leads this new campaign in partnership with the charity, Sense About Science, London. The aim is to remove regulatory and other barriers to the conduct of high-quality randomised trials. Currently, more than 100 trialists from 22 countries along with 5 research organisations have signed up to support the campaign.
Collaborator Contribution Collaborations are helping to promote the campaign and helping to write new guidelines for the conduct of high-quality randomised trials.
Impact A letter prepared by CTSU has been signed by more than 100 trialists in 22 countries and 5 research organisations and sent to the European Medicines Agency, EMA pointing out the fundamental problems with ICH-GCP, the structural problems with ICH itself and the failure of ICH's recent proposed update to address these problems.
Start Year 2015
 
Description Sensible Guidelines for the Conduct of Clinical Trials 
Organisation Duke University
Country United States of America 
Sector Academic/University 
PI Contribution Co-ordinated by CTSU with Duke & McMaster Universities.
Collaborator Contribution Academic collaborators
Impact Improve regulatory environment for clinical trials
Start Year 2007
 
Description Sensible Guidelines for the Conduct of Clinical Trials 
Organisation McMaster University
Country Canada 
Sector Academic/University 
PI Contribution Co-ordinated by CTSU with Duke & McMaster Universities.
Collaborator Contribution Academic collaborators
Impact Improve regulatory environment for clinical trials
Start Year 2007
 
Description Annual Oxford-Stanford Big Data in Biomedicine conferences: Organising committee and speaker 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact To highlight the potential of big-data to improve population health.

None.
Year(s) Of Engagement Activity 2014
URL http://bigdata.stanford.edu/big-data-for-population-health-martin-landray/
 
Description CTSU Participant Panel Meetings 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Patients, carers and/or patient groups
Results and Impact CTSU Participant Panel was established in 2013 to involve trial participants who live locally in the design, running and dissemination of our studies as well as providing a forum to develop new research ideas.

None.
Year(s) Of Engagement Activity 2013,2014,2015
 
Description DRUG INFORMATION ASSOCIATION, Boston, 2013: Chair and speaker - Approaches to Quality Risk Management: Understanding What Matters 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Increase awareness of using quality by design principles for designing randomised trials.

None.
Year(s) Of Engagement Activity 2013
 
Description DRUG INFORMATION ASSOCIATION, Webinar, 2013: Chair and speaker - Clinical Trials: Rethinking How We Ensure Quality 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact To increase awareness of adopting quality by design principles to design randomised trials.

None.
Year(s) Of Engagement Activity 2013
 
Description Drug Information Association, Chicago, 2011: Session Chair and speaker: Monitoring and source verification: New approaches to quality 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact To highlight new approaches to trial monitoring.

None.
Year(s) Of Engagement Activity 2011
 
Description Drug Information Association, Chicago, 2011: Session Chair and speaker: Quality by Design: Planning Quality on Multiple Fronts 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Increased awareness of using quality by design principles in designing randomised trials.

None.
Year(s) Of Engagement Activity 2011
 
Description East-West Alliance Global Symposium - Big Data for Precision Medicine Hong Kong 2014: Speaker big-data for population health 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact To increase awareness of the potential of big-data to improve population health.

None.
Year(s) Of Engagement Activity 2014
URL http://www.med.hku.hk/ewa2014/video14.htm
 
Description Edinburgh Clinical Trials Course, Edinburgh UK, 2012: Speaker - Monitoring Trials Efficiently 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact To increase awareness of methods available to monitor randomised trials more efficiently.

None.
Year(s) Of Engagement Activity 2012
 
Description FDA Clinical Trial Transformation Initiative Anti-Bacterial Drug Development Group - Member of Working Group 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact To increase awareness of efficient ways to conduct randomised trials to improve anti-bacterial drug development.

None.
Year(s) Of Engagement Activity 2012,2013,2014,2015
 
Description FDA Clinical Trials Transformation Initiative Quality by Design Training Meetings: course organiser 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Workshops addressed the principles and application of high quality clinical trial methodology through lectures, discussion of principles, exemplars and case studies (conducted in small breakout groups). To date there have been 4 courses (each 1.5 days) held in Bethesda, USA, and 1 arranged in association with EMA in London. These have been attended by senior staff from regulators (FDA, EMA, MHRA), pharmaceutical and medical device companies, clinical research organizations, academia, institutional review boards, and by patient advocates

None.
Year(s) Of Engagement Activity 2012,2013,2014
 
Description ICON Webinar, 2012: Speaker - Role of risk-based monitoring in cardiovascular outcomes studies 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact To increase awareness of using a risk-based approach to monitoring to cardiovascular trials.

None
Year(s) Of Engagement Activity 2012
 
Description Induction training for new members of CAG on research databases 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact Training for new CAG members on research databases to support large-scale cohorts and randomised trials.
Year(s) Of Engagement Activity 2016
 
Description Isis Innovation & Oxford AHSN Technology Showcase 2015 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact eHealth & Big Data - Innovation with Impact
Year(s) Of Engagement Activity 2015
 
Description Japanese Circulation Society: 2014 - Speaker How can we conduct sensible investigator-initiated clinical research? Purposes, study design, infrastructure and regulation" 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact To increase awareness of more efficient to conduct large randomised trials.

None.
Year(s) Of Engagement Activity 2014
 
Description Life Sciences Strategy Workshop 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Office for Life Sciences (Dept of Health/Dept of Business Enterprise, Innovation and Skills) Life Sciences Strategy Workshop
Year(s) Of Engagement Activity 2017
 
Description MRC Hubs for Trials Methodology Research, Annual Meeting, Birmingham UK, 2012: Speaker FDA Clinical Trial Transformation Initiative Monitoring Project: Developing effective quality systems in clinical trials 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact To increase awareness of using quality by design principles in randomised trial design.

None.
Year(s) Of Engagement Activity 2012
 
Description MRC Hubs for Trials Methodology Research, Liverpool UK, 2012: Speaker - Current perspectives on monitoring in clinical trials: Clinical Trials Transformation Initiative update and recommendations 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact To increase awareness of using quality by design principles for randomised trial design.

None.
Year(s) Of Engagement Activity 2012,2013
 
Description MRC Hubs for Trials Methodology Research, Oxford UK, 2012: Speaker session on statistical monitoring 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact To increase awareness of the use of central statistical monitoring for the more efficient conduct of randomised trials.

None.
Year(s) Of Engagement Activity 2012
 
Description Media coverage: City is at the forefront of disease prevention 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact To increase awareness of public health research in Oxford.

None.
Year(s) Of Engagement Activity 2014
URL http://www.oxfordmail.co.uk/news/11365255.print/
 
Description Media coverage: Clinical trials: how to get closer to the right answer with less effort 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact To highlight modern principles for the efficient conduct of randomised trials and the existing barriers to them.

None.
Year(s) Of Engagement Activity 2013
 
Description Media coverage: Testing, Testing 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact To highlight the value of reliable evidence from randomised trials and the current barriers to their conduct.

None.
Year(s) Of Engagement Activity 2014
URL http://www.economist.com/news/britain/21608775-nation-losing-its-grip-valuable-industry-testing-test...
 
Description Participation in HRA public dialogue workshop to give expert input on health research 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact Public dialogue organised by HRA on issues on use of health records for research, simple consent models and more widespread use of randomised trials.
Year(s) Of Engagement Activity 2014
 
Description Participation in careers fair/key skills workshop for year 10 pupils (South Wolds Academy, Notts) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Schools
Results and Impact More than 100 year-10 pupils attended talk on a career is medical research and workshop on the obesity epidemic to highlight key principles in epidemiology.

Invited back on several occasions to give other talks about a career in science.
Year(s) Of Engagement Activity 2014,2015
 
Description School visit 
Form Of Engagement Activity Participation in an open day or visit at my research institution
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Schools
Results and Impact Talk to year 8 pupils about heart disease
Year(s) Of Engagement Activity 2016
 
Description Sensible Guidelines for Clinical Trials, Toronto Canada, 2012: Speaker - Ensuring quality: The role of monitoring 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact To increase awareness of using central statistical monitoring to efficiently ensure quality and patient safety in randomised trials.

None.
Year(s) Of Engagement Activity 2012
 
Description Society for Clinical Trials, Boston, 2013: Speaker - Monitoring Trials Efficiently 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact To increase awareness of using quality by design principles to improve the monitoring of randomised trials.

None.
Year(s) Of Engagement Activity 2013
 
Description Society for Clinical Trials, Miami, 2012 Session: Update on the Clinical Trials Transformation Initiative: Session chair and speaker - Rethinking approaches to clinical trial oversight and premarket safety management 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact To increase awareness of more effective ways to manage and monitor randomised trials.

None.
Year(s) Of Engagement Activity 2012
 
Description Talk to year 9/10/11 pupils on how to build a career in scientific research (South Wolds Academy, Notts) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Schools
Results and Impact Over 300 year 9/10/11 pupils attended 3 talks.

Invited to speak to other year groups at school.
Year(s) Of Engagement Activity 2014,2015
 
Description The AHSN Alumni Summit 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact The Alumni Summit
8 - 10 July 2015, Oxford
Strengthening our community of life scientists - at home and abroad
Year(s) Of Engagement Activity 2015
 
Description Training for Research Ethic Committee members on the risks and benefits of research 
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 Risk benefit of research training has been undertaken on two occasions at national HRA training, at the annual REC Chair's meeting and to a Manchester REC. The training was also delivered at the EFGCP annual meeting in January 2014.

Increased awareness of the balance of the risks and benefits of research.
Year(s) Of Engagement Activity 2013,2014,2015
 
Description Training on risk/benefits of research to UKCRC Registered CTU QA Away Day 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Training session for QA staff on risks and benefits of research
Year(s) Of Engagement Activity 2014