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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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Development and Validation of the ADHD Benefits of Coaching Scale (ABCS)
Objective: Develop and validate the ADHD Benefits of Coaching Scale (ABCS), a self-report instrument designed to measure benefits of ADHD coaching in college students. Method: Concepts were elicitedExpand
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Assessing treatment benefit of telotristat etiprate in patients with carcinoid syndrome: Patient exit interviews
Assessing Treatment Benefit of Telotristat Etiprate in Patients with Carcinoid Syndrome : Patient Exit Interviews
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FDA PATIENT-REPORTED OUTCOME LABELING OF NOVEL THERAPIES (2011-2015)
Endpoint Status • The majority of PRO labeling (76.7%) during 2011-2015 was based on primary endpoints. PRO labeling for seven products was based only on secondary endpoints; for six of theseExpand
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A Review Of Patient-Reported Outcome Orphan Drug Labels In The United States From January 2006-September 2013: Analysis Of Evidence For Orphan Drug Pro Label Claims
Objectives: Previous reviews of patient-reported outcome (PRO) label claims did not distinguish products with orphan designation. Literature suggests that less evidence is required for orphan drugExpand
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ADHD Benefits of Coaching Scale