Cross-cutting theme 1: Big Data and Computing innovation

Lead Research Organisation: University of Oxford

Abstract

The emergence of new digital technologies is allowing huge quantities of information on health exposures and outcomes to be captured, stored, and analysed using advanced statistical techniques. ‘Big Data’ will provide new ways to conduct research and offers the potential of a dramatic increase in the scale and efficiency of clinical studies. This pioneering programme of work within PHRU aims to harness Big Data methodology to facilitate large-scale epidemiological studies and improve the efficiency of randomised trials by identifying barriers to their efficient conduct.
This work is supported by a computing team that produces and maintains systems designed to meet the specific requirements of our new and on-going studies, and to ensure that they are sufficiently adaptable to provide a platform for future work. Our systems focus on aspects that are key to study quality: recruitment of large numbers of eligible participants; data collection and study conduct; study management, coordination and oversight; laboratory management including analysis and storage; ascertainment, confirmation and classification of outcome; and analysis, reporting and dissemination.

Technical Summary

The emergence of new digital technologies is allowing huge quantities of information on health exposures and outcomes to be captured, stored, and analysed using advanced statistical techniques. ‘Big Data’ will provide new ways to conduct research and offers the potential of a dramatic increase in the scale and efficiency of clinical studies.
The work of this cross-cutting theme comprises 3 related elements of direct relevance to the quality and operational efficiency of large randomized controlled trials and prospective cohort studies:

(1) Novel methods for data acquisition and analysis of phenotype
We are developing new approaches for assembling sufficiently large numbers of people with the relevant condition; ascertaining a suitable range of important clinical outcomes over a prolonged period of time; and measuring aspects of exposure and disease that are not well represented in medical records or are poorly captured through simple questionnaires. Our methods take advantage of the widespread use of routine electronic clinical records and increasing adoption of digital technology (including smartphones and mobile sensors). The work is being conducted in partnership with Health Data Research UK, the NIHR Health Informatics Collaborative, and NHS Digital and is of direct relevance to the UK Life Sciences Industrial Strategy. The individual trials and cohort studies designed and conducted by the PHRU programmes provide opportunities for the development and evaluation of new methods, including demonstration of their impact.

(2) Efficient methods for data curation and study coordination
The scale and duration of our cohort studies and randomized trials pose significant challenges for data management. Not only are the studies large, they are very long-term (many decades) and typically contain sensitive and/or personal data. This work requires careful evaluation of new technologies (e.g. virtualisation of storage and networking, firewalls and malware protection, archiving and large data storage), adaptation to and implementation of evolving data standards, and development of new approaches to meet the operational needs of those managing the research projects. Key areas of innovation and development include a secure, large-scale data storage and distribution system for clinical study data (including genotyping and imaging), use of CDISC and other data standards for clinical trials and meta-analyses, and provision of software systems for effective study management, clinical and operational oversight, and central statistical monitoring.

(3) Pro-active approaches to Information Governance and Research Regulation
We continue to play a leading role in national and international efforts to promote proportionate and coordinated approaches to information governance, including through contributions to the NHS Digital Research Advisory Group and Office for Strategic Coordination of Health Research. Likewise, we continue to make the case for reform in clinical trials Good Clinical Practice “GCP” regulations through our MoreTrials campaign and leading contributions to the activities of the FDA Clinical Trials Transformation Initiative.

Publications

10 25 50
 
Description BHF Oxford Centre of Research Excellence Infrastructure Award
Amount £30,000 (GBP)
Organisation British Heart Foundation (BHF) 
Sector Charity/Non Profit
Country United Kingdom
Start 02/2019 
 
Description MRC UK-Malaysia Health Research Partnership
Amount £176,000 (GBP)
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start  
 
Description EHR-informed trial of timing of stoma in neonates 
Organisation Manchester University NHS Foundation Trust
Country United Kingdom 
Sector Public 
PI Contribution data analysis, methodology
Collaborator Contribution study design, clinical trial, funding application
Impact • HTA application successful
Start Year 2019
 
Description Global Hearts Initiative: Expanding the Evidence Base for Cardiovascular Disease Risk Factors 
Organisation Centers for Disease Control and Prevention (CDC)
Country United States 
Sector Public 
PI Contribution Collaboration with Global Non-Communicable Disease Branch of the US Center of Disease Control. Funding from CDC-Foundation. Title 'Global Hearts Initiative: Expanding the Evidence Base for Cardiovascular Disease Risk Factors'. There is a formal agreement in place.
Collaborator Contribution academic partnership
Impact n/a
Start Year 2019
 
Description Hospital data for early onset schizophrenia 
Organisation Oxford Health NHS Foundation Trust
Country United Kingdom 
Sector Public 
PI Contribution Since August 2019, I have worked with Dr Anthony James, Warneford Hospital, Oxford Health NHS Foundation Trust, on a project utilising routine hospital data to study early onset schizophrenia. I performed data analysis and wrote a manuscript.
Collaborator Contribution academic collaboration
Impact data analysis and manuscript
Start Year 2019
 
Description NIHR Health Informatics Collaborative 
Organisation National Institute for Health Research
Country United Kingdom 
Sector Public 
PI Contribution NIHR Health Informatics Collaborative (HIC) Acute Coronary Syndrome Group. The Group is a collaboration of clinicians and data scientists from five NHS Trusts focused on cardiovascular research. There is a formal agreement in place.
Collaborator Contribution NIHR Health Informatics Collaborative (HIC) Acute Coronary Syndrome Group. The Group is a collaboration of clinicians and data scientists from five NHS Trusts focused on cardiovascular research. There is a formal agreement in place.
Impact n/a
Start Year 2019
 
Description NIHR Health Informatics Collaborative (HIC) Cardiovascular Scientific Steering Group 
Organisation National Institute for Health Research
Country United Kingdom 
Sector Public 
PI Contribution data sharing agreements between NHS Trusts
Collaborator Contribution data sharing agreements between NHS Trusts
Impact n/a
Start Year 2019
 
Description National Sentinel Stroke Audit Data 
Organisation King's College London
Country United Kingdom 
Sector Academic/University 
PI Contribution working King's College London to analyse the National Sentinel Stroke Audit data. It is a new collaboration started in January 2020, and I am planning to obtain access to stroke audit data.
Collaborator Contribution data provision
Impact non yet
Start Year 2020
 
Description Obesity and non-communicable disease in Malaysia: an imaging study of 6000 adults in the Malaysian Cohort Study 
Organisation University Kebangsaan Malaysia Medical Centre
Country Malaysia 
Sector Hospitals 
PI Contribution bCollaboration with the Collaboration with Universiti Kebangsaan Malaysia. Funding from MRC UK-Malaysia Health Research Partnership. Title: Obesity and non-communicable disease in Malaysia: an imaging study of 6000 adults in the Malaysian Cohort Study. The collaboration will facilitate an imaging sub-study of 6000 participants of the Malaysian Cohort Study. There is a formal agreement in place.
Collaborator Contribution academic partnership
Impact n/a
Start Year 2019
 
Description Perinatal and Paediatric Epidemiological Research 
Organisation University of Paris - Descartes
Department Medicine
Country France 
Sector Academic/University 
PI Contribution study design, data analysis, methodology
Collaborator Contribution study design, data analysis, methodology
Impact Feasibility study of using EHR to study incidence of severe acute maternal morbidity in England. • Study complete; published in Paediatric and Perinatal Epidemiology
Start Year 2019
 
Description Studies of hospital-recorded paediatric infections 
Organisation University of Oxford
Department Oxford Vaccine Group
Country United Kingdom 
Sector Academic/University 
PI Contribution study design, data analysis, methodology
Collaborator Contribution clinical
Impact • Study of congenital viral infections (complete); published in The Lancet Infectious Diseases: https://doi.org/10.1016/S1473-3099(19)30416-5 • Study of group B strep incidence, perinatal associations and outcomes (in progress)
Start Year 2019
 
Description BRC Open Day 
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 Public/other audiences
Results and Impact 24 May 2019 - BRC Open Day, John Radcliffe Hospital, Oxford, Olena Seminog together with Raph Goldacre set up a table and talked to public about the research work of the Unit of Health-Care Epidemiology, and more broadly, Big Data Institute. Attendance 400 people
Year(s) Of Engagement Activity 2019
 
Description Oxford Open Doors 2019 
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 Public/other audiences
Results and Impact 14 September 2019 - Big Data Institute Open Day, part of Oxford Open Door, Olena Seminog set up a table and represented the UHCE team by engaging in conversations with public about the team's research projects. Attendance 250 people.
Year(s) Of Engagement Activity 2019
 
Description Stroke mortality interviews 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact May 2020 - Olena Seminog was interviewed on the television about the paper on the reduction in stroke mortality, she was interviewed and answered the listener's calls on LBC radio, published references to her study
Year(s) Of Engagement Activity 2019