The Melbourne EpiCentre is a collaborative research centre of the University of Melbourne and Melbourne Health embedded within the Royal Melbourne Hospital. It is an academic centre of excellence with research, education, health care quality and safety, and organisation-improvement agenda. The goal of the centre is to promote and run high quality clinical, non-clinical and biostatistical methodological studies, both locally and internationally.
Melbourne EpiCentre is a National Collaborative Research Infrastructure Strategy (NCRIS) funded facility, with expertise in the planning, design, data management, statistical and clinical reporting of clinical trials, conforming to FDA requirements and industry standards. The EpiCentre is leading several early and late phase clinical trials and clinical epidemiological projects with large primary and ambulatory care databases from the US and UK. The EpiCentre also provides study design, data management and biostatistical support for diverse research groups across the University and Melbourne Health, as well as providing analytical support for data relating to health care services quality and safety.
The EpiCentre is headed by Professor Sanjoy Paul.
Research engagement of the EpiCentre includes:
Clinical study design
Consulting services in various aspects of study design including: identification and choice of primary and secondary outcomes, protocol development, comparative power analyses, and statistical analysis approaches
Clinical database development and management
The EpiCentre complies with all FDA requirements and industry standards for all clinical data management, including compliance with 21 CFR Part 11. Key aspects include: development of electronic case report form (eCRF), development and management of electronic study database, web-hosting of database, training of project research staff and randomisation services.
Biostatistical / clinical reporting
The EpiCentre offers high level expertise in the development and management of Charter for Data Safety and Monitoring Committees, development of statistical analysis plans for safety and efficacy reporting, statistical analyses and statistical and clinical reporting. The EpiCentre actively participates in research manuscript development with research collaborators.
Professor Sanjoy Paul is an internationally recognised clinical trialist, biostatistician and a research administrator with long-standing experience in design and conduct of clinical trials and pharmaco-epidemiological studies in the fields of metabolic diseases. Prof. Paul’s current role is Chair Professor of Clinical Biostatistics, Epidemiology & Health Services Research, University of Melbourne, and Director of the Melbourne EpiCentre, a collaborative research centre embedded within the Royal Melbourne Hospital, Melbourne, Australia.
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Prior to moving his research group to Melbourne Prof. Paul established the Clinical Trials and Biostatistics Unit within the QIMR Berghofer Medical Research Institute (2013-16). This move enabled him to support QIMR Berghofer’s strategic aim in further developing its translational research abilities, including clinical trials, and built on his earlier success in establishing the Queensland Clinical Trials & Biostatistics Centre at The University of Queensland (2009-13). Prior to moving to Australia in 2009, Prof. Paul created the Statistics & Modelling Group of the University of Oxford Centre for Diabetes, Endocrinology and Metabolism in the UK. Prof. Paul is highly regarded for his strategic contributions in developing effective industry-academia research partnerships, and for playing pivotal roles in developing strategies to conduct clinical and pharmaco-epidemiological studies of high public health importance using real world data.
He has been working with primary care and ambulatory care databases from the UK and USA for several years. Prof. Paul continues to play a pivotal role in the development of Australia’s translational research capabilities as one of the principal members of Therapeutic Innovation Australia. He also acts as an expert advisor to Therapeutic Goods Administration of Australia (TGA) and numerous clinical and non-clinical programmes led by his international academic and industry collaborators.
In addition to attracting significant competitive research grants (~$18 million since 2010) from NHMRC, the Commonwealth government, and pharmaceutical companies, he has successfully built highly productive collaborations with international institutes and multinational pharmaceutical companies, including Imperial College London, University of Oxford, Peking University, Roche, AstraZeneca and Novo Nordisk. Prof. Paul played an instrumental role in designing large multi-national outcome trials to conduct cardiovascular safety studies with anti-diabetes drugs (TECOS and ACE trials). He played a leading role in landmark studies in diabetes and cardiovascular diseases that have received widespread international acclaim, including the “UKPDS Post-trial Monitoring Study”, and the “Treating To Target In Type 2 Diabetes” trial. He has developed designs, written study protocols and statistical analysis plans for over 100 clinical studies.
Currently Prof. Paul is running 7 early and late phase multicenter/multinational clinical trials. He is also currently leading several clinical, pharmaco-epidemiological and biomarker studies in the fields of auto-immune and metabolic diseases combining clinical trial and large primary care data. These research projects cover three broad areas: the long-term pathophysiology of risk factors in patients with metabolic diseases including diabetes, and how different anti-diabetes and cardio-protective drugs modify the vascular and mortality risks; exploratory studies to evaluate the cardio-metabolic effects of treatment with incretin based therapies in diabetes; and methodological and applied studies to develop robust approaches to design pharmaco-epidemiological studies and conduct analyses with large longitudinal electronic health records from primary care systems. In addition, he actively provides expert consulting in designing and analysis of clinical and non-clinical studies to pharmaceutical companies and international academic collaborators.
Prof. Paul has published in highly acclaimed research journals that include the New England Journal of Medicine, Diabetes, Diabetes Care, Diabetologia, Science Translational Medicine, Clinical Infectious Diseases and Diabetes Obesity & Metabolism, with citations of 9237 and h-Index of 21 (Google Scholar, March 2017), having commenced his research career in 2004. Three of his publications are recommended in the prestigious Faculty of 1000, and have attracted editorials in NEJM.
Prof. Paul’s research management philosophy is based on innovation and growth, new service and technology development, early-stage management and entrepreneurship. He has a proven track record of managing large and complex projects encompassing industry partners. He is considered an effective strategist and leader with a strong ability to lead and develop lasting partnerships with external and internal stakeholders.
300 Grattan Street
Parkville, Vic. 3050 AUSTRALIA
Tel: + 61 3 9342 8772