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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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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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Mortality and Causes of Death in Patients with Sporadic Inclusion Body Myositis: Survey Study Based on the Clinical Experience of Specialists in Australia, Europe and the USA
Background: There is a paucity of data on mortality and causes of death (CoDs) in patients with sporadic inclusion body myositis (sIBM), a rare, progressive, degenerative, inflammatory myopathy thatExpand
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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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US FDA patient-reported outcome guidance: great expectations and unintended consequences
Release of the US FDA patient-reported outcome (PRO) guidance raised expectations within the pharmaceutical industry for the use of PRO measures in support of labeling claims. The FDA developed theExpand
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Integration of patient-reported outcomes in multiregional confirmatory clinical trials☆
Abstract Introduction The increasing complexities of conducting multiregional trials and an evolving regulatory environmentExpand
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Psychometric evaluation of a caregiver diary for the assessment of symptoms of respiratory syncytial virus
BackgroundThere are no clinical outcome assessment (COA) tools developed in accordance with Food and Drug Administration (FDA) guidance suitable for the evaluation of symptoms associated withExpand
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A Review of Patient-Reported Outcome Labeling in the United States (2011-2015).
BACKGROUND A review of new drug approvals (NDAs) by the Food and Drug Administration (FDA) for 2006 to 2010 showed that 24.1% of new drugs had patient-reported outcome (PRO) labeling. OBJECTIVES ToExpand
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Potential of patient-reported outcomes as nonprimary endpoints in clinical trials
BackgroundThe purpose of this research was to fully explore the impact of endpoint type (primary vs. nonprimary) on decisions related to patient-reported outcome (PRO) labeling claims supported byExpand
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