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- Publications
- Influence
Patient-Reported Outcomes Labeling for Products Approved by the Office of Hematology and Oncology Products of the US Food and Drug Administration (2010-2014).
- A. Gnanasakthy, C. Demuro, M. Clark, E. Haydysch, E. Ma, V. Bonthapally
- Medicine
- Journal of clinical oncology : official journal…
- 27 September 2016
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 license… Expand
Development and Validation of the ADHD Benefits of Coaching Scale (ABCS)
- L. Deal, Jodi Sleeper-Triplett, +4 authors T. M. Brown
- Psychology, Medicine
- Journal of attention disorders
- 1 March 2015
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 elicited… Expand
Assessing treatment benefit of telotristat etiprate in patients with carcinoid syndrome: Patient exit interviews
- L. Anthony, D. Hoersch, +17 authors P. Lapuerta
- Medicine, Biology
- 23 November 2016
Assessing Treatment Benefit of Telotristat Etiprate in Patients with Carcinoid Syndrome : Patient Exit Interviews
FDA PATIENT-REPORTED OUTCOME LABELING OF NOVEL THERAPIES (2011-2015)
- A. Gnanasakthy, M. Mordin, E. Haydysch, C. Demuro
- Medicine
- 1 May 2016
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 these… Expand
Assessing US patients' and dermatologists' experiences with severe chronic hand eczema:
- D. DiBenedetti, M. Reynolds, E. Sherrill, E. Haydysch
- Medicine
- 2015
- 1
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
- M. Clark, Chelsea Simons, E. Haydysch, C. Demuro, A. Gnanasakthy
- Medicine
- 1 May 2014
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 drug… Expand
Patient Perceptions of Psoriasis: A Review of the Survey Literature by Geography
- M. Mordin, E. Haydysch, P. Graham-Clarke, A. Gnanasakthy, E. Nikaï
- Medicine
- 1 May 2016
ADHD Benefits of Coaching Scale
- L. Deal, Jodi Sleeper-Triplett, +4 authors T. M. Brown
- Psychology
- 11 May 2015