Use of Clinical Outcome Assessments in New Drug Approvals by the US Food and Drug Administration Divisions of Neurology I and II-Reference-Cited by-同舟云学术

Use of Clinical Outcome Assessments in New Drug Approvals by the US Food and Drug Administration Divisions of Neurology I and II

Published:2022-09-07 Issue:9 Volume:5 Page:e2230530
ISSN:2574-3805
Container-title:JAMA Network Open
language:en
Short-container-title:JAMA Netw Open

Author:

Schein Yvette¹²,Fernandez Lynch Holly¹³⁴

Affiliation:

1. Perelman School of Medicine, University of Pennsylvania, Philadelphia

2. Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland

3. Carey Law School, University of Pennsylvania, Philadelphia

4. Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia

Publisher

American Medical Association (AMA)

Subject

General Medicine

Link

https://jamanetwork.com/journals/jamanetworkopen/articlepdf/2795989/schein_2022_ld_220194_1661881878.61948.pdf

Reference6 articles.

1. Clinical outcome assessments: conceptual foundation—report of the ISPOR Clinical Outcomes Assessment–Emerging Good Practices for Outcomes Research Task Force.;Walton;Value Health,2015

2. Content validity—establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report, part 1: eliciting concepts for a new PRO instrument.;Patrick;Value Health,2011

3. Content validity—establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report, part 2: assessing respondent understanding.;Patrick;Value Health,2011

4. U.S. Food and Drug Administration. Division of Clinical Outcome Assessment (DCOA). 2021. Accessed July 19, 2022. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/division-clinical-outcome-assessment-dcoa

5. U.S. Food and Drug Administration. Patient-reported outcome measures: use in medical product development to support labeling claims—guidance for industry. 2009. Accessed July 19, 2022. https://www.fda.gov/downloads/drugs/guidances/ucm193282.pdf

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