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European Pharmaceutical Contractor

Strategic Planning with ePROs

Nancy Kline Leidy and Makiko Meguro at United BioSource Corporation examine the need for electronic patient-reported outcomes, and ask what strategies will lead to the best outcomes

As the industry moves toward paperless clinical trials, patient-reported outcome (PRO) measures are also migrating toward electronic options. Although ‘paperand- pencil’ modes of administration will continue to prevail in the short-term, the medium- and long-term outlook for electronic methods to capture PROs (ePROs) looks promising, particularly with the advancement of new, user-friendly technology and the development of questionnaires designed with the ePRO platform in mind.

With the burgeoning number of e-options – from web-based and interactive voice response (IVR) systems to handheld devices, such as personal digital assistants (PDAs) – it will become increasingly important for decision-makers within pharmaceutical companies to make the best strategic decisions about whether, when and how to use various technologies. Identifying the best platform for ePROs must take into consideration a variety of factors, including the type and nature of the outcome, the patient population, trial design, regulatory requirements and the drug development programme overall. Frequently, the best solution is not a single platform, but a combination of data collection methods.


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Nancy Kline Leidy, PhD is Senior Vice President of Scientific Affairs for United BioSource Corporation in Bethesda, Maryland, US. She has over 25 years of experience in clinical and health outcomes research, specialising in instrument development, psychometric testing, and the design and analysis of clinical trials. She has served on the faculties of Michigan State University and the University of Arizona, the research staff of the International Council of Nurses in Geneva, Switzerland, and as an intramural scientist at the National Institutes of Health (NIH). Nancy holds a PhD in Clinical Research from the University of Michigan.

Makiko Meguro, Research Associate at United BioSource Corporation’s London office, focuses on developing and validating PRO instruments, with expertise in psychometric testing, multi-level modelling and statistical analysis. Prior to joining UBC, she worked at GfK Healthcare in pharmaceutical market research and at St George’s Hospital, London, UK, with responsibility for multinational HRQL project management involving patient-report outcomes and preference-based utility instrument development and validation. Makiko holds a BSc (Hons) in Psychology and Neuroscience and a Master of Philosophy in Psychology from the University of Manchester, UK. She is currently working towards her PhD in Health Psychology at the University of London.

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Nancy Kline Leidy
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Makiko Meguro
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