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A new approach to the mathematical formulation of lactation curves
Six alternative lactation curves were derived by considering the proportional rates of change in milk yield during lactation. Experimental data showed that rates of change do not necessarily fall toExpand
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Conducting economic evaluations alongside multinational clinical trials: toward a research consensus.
Demand for economic evaluations in multinational clinical trials is increasing, but there is little consensus about how such studies should be conducted and reported. At a workshop in Durham, NorthExpand
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Patient reported outcomes: looking beyond the label claim
The use of patient reported outcome scales in clinical trials conducted by the pharmaceutical industry has become more widespread in recent years. The use of such outcomes is particularly common forExpand
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Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient.
Data reported directly by patients about how they feel and function are rarely included in oncology drug labeling in the United States, in contrast to Europe and to nononcology labeling in the UnitedExpand
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Assessment of PRO label claims granted by the FDA as compared to the EMA (2006-2010).
BACKGROUND The US Food and Drug Administration (FDA) provides formal guidance for the use of patient-reported outcomes (PROs) in support of labeling claims, whereas the European Medicines AgencyExpand
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Savings in the cost of caring for patients with Alzheimer's disease in Canada: an analysis of treatment with rivastigmine.
OBJECTIVE To estimate per-patient potential cost savings using rivastigmine in the treatment of Alzheimer's disease (AD) in Canada. BACKGROUND In recent years, new members of a class ofExpand
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Reasons for rejection of patient-reported outcome label claims: a compilation based on a review of patient-reported outcome use among new molecular entities and biologic license applications,
OBJECTIVES Previous analyses of patient-reported outcome (PRO) label claims concentrated only on successful label claims. The goal of this research was to explore the reasons why PRO label claimsExpand
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Patient-Reported Outcomes Labeling for Products Approved by the Office of Hematology and Oncology Products of the US Food and Drug Administration (2010-2014).
PURPOSE To review the use of patient-reported outcome (PRO) data in medical product labeling granted by the US Food and Drug Administration (FDA) for new molecular entities and biologic licenseExpand
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Psychometric evaluation of the Sheehan Disability Scale in adult patients with attention-deficit/hyperactivity disorder
Inattention and impulsivity symptoms are common among adults with attention-deficit/hyperactivity disorder (ADHD), which can lead to difficulty concentrating, restlessness, difficulty completingExpand
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A review of patient-reported outcome labels in the United States: 2006 to 2010.
OBJECTIVE In 2004, Willke and colleagues reviewed the efficacy endpoints reported in the labels of new drugs approved in the United States from 1997 through 2002 to evaluate the use ofExpand
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