Cross-cutting theme 1: Big Data and Computing innovation
Lead Research Organisation:
University of Oxford
Department Name: UNLISTED
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.
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.
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.
Organisations
- University of Oxford (Lead Research Organisation)
- UNIVERSITY OF OXFORD (Collaboration)
- University Kebangsaan Malaysia Medical Centre (Collaboration)
- NHS DIGITAL (Collaboration)
- MANCHESTER UNIVERSITY NHS FOUNDATION TRUST (Collaboration)
- University of Paris - Descartes (Collaboration)
- Oxford Health NHS Foundation Trust (Collaboration)
- Centers for Disease Control and Prevention (CDC) (Collaboration)
- National Institute for Health Research (Collaboration)
- KING'S COLLEGE LONDON (Collaboration)
People |
ORCID iD |
Publications
Chan MS
(2021)
A Biomarker-based Biological Age in UK Biobank: Composition and Prediction of Mortality and Hospital Admissions.
in The journals of gerontology. Series A, Biological sciences and medical sciences
Nawab KA
(2021)
Accelerometer-measured physical activity and functional behaviours among people on dialysis.
in Clinical kidney journal
Kadambari S
(2020)
Congenital viral infections in England over five decades: a population-based observational study.
in The Lancet. Infectious diseases
Related Projects
Project Reference | Relationship | Related To | Start | End | Award Value |
---|---|---|---|---|---|
MC_UU_00017/1 | 01/04/2019 | 31/03/2024 | £5,782,000 | ||
MC_UU_00017/2 | Transfer | MC_UU_00017/1 | 01/04/2019 | 31/03/2024 | £2,644,000 |
MC_UU_00017/3 | Transfer | MC_UU_00017/2 | 01/04/2019 | 31/03/2024 | £3,269,000 |
MC_UU_00017/4 | Transfer | MC_UU_00017/3 | 01/04/2019 | 31/03/2024 | £1,831,000 |
MC_UU_00017/5 | Transfer | MC_UU_00017/4 | 01/04/2019 | 31/03/2024 | £2,183,000 |
Description | Interviewed for Lord O'Shaughnessy report into the future of commercial clinical trials |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Contribution to new or improved professional practice |
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 | RECOVERY (PI) |
Amount | £11,400,000 (GBP) |
Organisation | Flu Lab |
Sector | Charity/Non Profit |
Start |
Description | Chair, NHS DigiTrials Board |
Organisation | NHS Digital |
Country | United Kingdom |
Sector | Public |
PI Contribution | Technical co-development of conformed data layer and services layer. Coordination of Patient & Public Involvement and Engagement, including PPI members on the Board, Co-development Panel, public engagement meetings (Sophia has details), Use cases for ascertainment of clinical outcomes and for mailing 13,000 participants with information about trial results applied to RECOVERY trial. |
Collaborator Contribution | Invitation services piloted for UK vaccine trials and the PRINCIPLE trial Microsoft and IBM partners contributed technical and service design expertise. |
Impact | Feasibility service (beta release); support for the RECOVERY trial including information on study outcomes to support 6 key findings that have impacted NHS and global treatment policies for COVID-19 (dexamethasone & tocilizumab save lives; hydroxychloroquine, lopinavir, azithromycin, convalescent plasma, colchicine are ineffective). |
Start Year | 2019 |
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 | Activity for the RECOVERY Trial |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Media (as a channel to the public) |
Results and Impact | During the RECOVERY Trial, which investigates the efficacy of COVID treatments for hospitalized patients, trial investigators took part in media interviews on multiple occasions with media organisations across the world. This resulted in televised interviews, thousands of printed and digital media articles that have showcased this importance of this trial worldwide. |
Year(s) Of Engagement Activity | 2020,2021,2022 |
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 | Inside Health |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Media (as a channel to the public) |
Results and Impact | RECOVERY Trial featured on BBC R4's Inside Health in April 2021 |
Year(s) Of Engagement Activity | 2021 |
Description | Lecture to Friends of St Mary's Church, Bampton |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | Local |
Primary Audience | Public/other audiences |
Results and Impact | Lecture to Friends of St Mary's Church, Bampton |
Year(s) Of Engagement Activity | 2022 |
Description | Lecture to Nottingham BRC |
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 | Lecture to Nottingham BRC |
Year(s) Of Engagement Activity | 2022 |
Description | Lecture to York & Scarborough NHS Trust |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | Regional |
Primary Audience | Professional Practitioners |
Results and Impact | 21 Nov 2022 - Lecture to York & Scarborough NHS Trust |
Year(s) Of Engagement Activity | 2022 |
Description | Lecture/public meeting, Amey Hall, Abingdon School, Oxfordshire |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | Local |
Primary Audience | Public/other audiences |
Results and Impact | Lecture/public meeting, Amey Hall, Abingdon School, Oxfordshire |
Year(s) Of Engagement Activity | 2022 |
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 | Profile in The Lancet |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Media (as a channel to the public) |
Results and Impact | March 2022 - Profile in The Lancet |
Year(s) Of Engagement Activity | 2022 |
URL | https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(22)00527-X.pdf |
Description | St Hugh's School |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | Local |
Primary Audience | Schools |
Results and Impact | St Hugh's school 8 June 2021 and 2 November 2021 |
Year(s) Of Engagement Activity | 2021 |
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 |
Description | The Life Scientific |
Form Of Engagement Activity | A broadcast e.g. TV/radio/film/podcast (other than news/press) |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Media (as a channel to the public) |
Results and Impact | Subject of an episode of BBC Radio 4's The Life Scientific. Aired June 2022 |
Year(s) Of Engagement Activity | 2022 |