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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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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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Patient-reported outcome labeling claims and measurement approach for metastatic castration-resistant prostate cancer treatments in the United States and European Union
BackgroundMetastatic castration-resistant prostate cancer (mCRPC) and its treatment significantly affect health-related quality of life (HRQOL). Our objectives were to evaluate and compareExpand
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Item reduction and psychometric validation of the Oily Skin Self Assessment Scale (OSSAS) and the Oily Skin Impact Scale (OSIS).
INTRODUCTION Developed using focus groups, the Oily Skin Self Assessment Scale (OSSAS) and Oily Skin Impact Scale (OSIS) are patient-reported outcome measures of oily facial skin. OBJECTIVE The aimExpand
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The Impact Of Non-Muscle Invasive Bladder Cancer: Qualitative Research With Patients.
– Met criteria for one of the following NMIBC treatment groups: • Group 1: Bacillus Calmette–Guérin (BCG)-naïve, treated with transurethral resection of bladder tumor (TURBT) ± intravesicalExpand
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Cognitive dysfunction and work productivity in major depressive disorder
ABSTRACT Introduction: Major depressive disorder (MDD) is strongly associated with poor work-related outcomes. Cognitive dysfunction is prevalent in MDD, and research supports a correlation betweenExpand
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Impact of Measuring Patient-Reported Outcomes in Dermatology Drug Development
Although some symptoms of dermatologic diseases, such as pruritus and pain, can be subjectively assessed only by patients, the most commonly used endpoints in dermatology drug research traditionallyExpand
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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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