Cross-cutting theme 1: Big Data and Computing innovation

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.

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.