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home > epc > winter 2003 > next generation electronic patient diary applications in life cycle management and economic outcomes studies
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European Pharmaceutical Contractor

Next Generation Electronic Patient Diary Applications in Life Cycle Management and Economic Outcomes Studies

Electronic patient diaries (EPDs) were developed primarily for the collection of 21 CFR Part 11 compliant patient data in Phase II/II clinical studies. While these first generation EPDs are clearly adding value in clinical trial data management and FDA submissions, they do not meet the broader untapped potential of the technology. New generation EPD systems that cost-effectively integrate patient clinical status via medical devices with subjective data such as health-related quality of life (HRQOL) measurement, open a new world of previously unobtainable possibilities. ]

Many studies have now been reported which have employed EPD technology to record patient data in clinical trials. These trials have occurred in a wide range of clinical areas and with many different patient groups. The benefits of this technology over paper-based patient diaries are becoming widely recognised. It's now clear that e-diaries can help to improve patient compliance with study protocols and can greatly improve the accuracy of the data that are captured (1,2).

Although EPDs have proved to be very effective in recording information regarding timing and dosage of medication, and the nature and severity of adverse events in clinical trials, it could be argued that the full potential of this data collection method has not been realised. For example, regulation and reimbursement agencies across the world are becoming much more demanding in their information requirements and are expecting inclusion of HRQOL data for some studies. Decision-making bodies such as NICE require evidence of clinical and cost effectiveness and are increasing their demands on companies regarding the quality of data that are submitted. We believe that next generation EPD tools offer opportunities to help companies meet these requirements simply and economically.


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By Dr Brendan J Murray, CEO of Avalis AG eClinical, John Hutton, Vice President of European Operations and Head of Global Health Economics, and Dr Andrew Lloyd, Research Scientist, for MEDTAP International Inc

Dr Brendan Murray is founder and CEO of Avalis AG eClinical, a privately owned Swiss medical information technology company specialising in the development of second generation electronic patient diaries. He gained a PhD in Protein Chemistry and Molecular Biology from the University of Melbourne, Australia, before spending 10 years in the biotechnology and pharmaceutical industries in Australia, Europe and the US. In 1992 he left the industry as an entrepreneur to develop IT-related businesses in the knowledge management and health care sectors.


John Hutton, BSc Econ, BPhil, is Vice President of European Operations and Head of Global Health Economics for MEDTAP International, London. John has spent the last 20 years focusing on the economics of health care and medical technology and is currently concentrating on the economic evaluation of new pharmaceuticals. Prior to MEDTAP International, he held faculty positions in Economics at the University of Wales, Aberystwyth and the University of Aberdeen. He has acted as a consultant to the World Bank, World Health Organization and the Commission of the European Communities, and continues to teach health economics courses at the University of York and the University of London. He is a graduate of the London School of Economics, where he holds a Visiting Fellowship, and completed his post-graduate study at the University of York.


Andrew Lloyd, BSc, DPhil, joined MEDTAP International as a Research Scientist in December 2001. Dr Lloyd has a background in cognitive and health psychology and he completed his DPhil in the Psychology Department at York University in 1997. Dr Lloyd's main research interests are in the assessment of health related quality of life and medical decision-making, and patients' perception of risk related to treatment alternatives. Dr Lloyd has undertaken work in cardiovascular disease, Parkinson's disease, rheumatology, psychiatry, and obstetrics. These projects have included assessments of quality of life and cognitive function, surveys of patients' decision-making and audits of practice innovations.

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Dr Brendan Murray
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John Hutton
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Andrew Lloyd
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