Developing and Implementing Performance Outcome Assessments: Evidentiary, Methodologic, and Operational Considerations-Reference-Cited by-同舟云学术

Developing and Implementing Performance Outcome Assessments: Evidentiary, Methodologic, and Operational Considerations

Published:2019-01 Issue:1 Volume:53 Page:146-153
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Richardson Elizabeth^ORCID,Burnell Jessica,Adams Heather R.,Bohannon Richard W.,Bush Elizabeth Nicole,Campbell Michelle,Chen Wen Hung,Coons Stephen Joel,Papadopoulos Elektra,Reeve Bryce R.,Rooks Daniel,Daniel Gregory

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Link

http://link.springer.com/content/pdf/10.1177/2168479018772569.pdf

Reference9 articles.

1. FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource. Silver Spring, MD: Food and Drug Administration; Bethesda, MD: National Institutes of Health; 2016. https://www.ncbi.nlm.nih.gov/books/NBK338448/. Accessed September 20, 2017.

2. Walton MK, Powers JH, Hobart J, et al. Clinical outcome assessments: conceptual foundation—report of the ISPOR Clinical Outcomes Assessment—Emerging Good Practices for Outcomes Research Task Force. Value Health. 2015;18:741–752.

3. World Health Organization. International Classification of Functioning, Disability and Health (ICF). Geneva: World Health Organization; 2001.

4. United States Food and Drug Administration Guidance for Industry. Patient-reported outcome measures: use in medical product development to support labeling claims. https://www.fda.gov/downloads/drugs/guidances/ucm193282.pdf. Published 2009. Accessed September 20, 2017.

5. United States Food and Drug Administration. Wheel and spokes diagram: clinical outcome assessments. https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/UCM370175.pdf. Accessed September 20, 2017.

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