Leveraging real‐world evidence for determining performance goals for medical device studies-Reference-Cited by-同舟云学术

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Leveraging real‐world evidence for determining performance goals for medical device studies

Published:2021-09-24 Issue:29 Volume:40 Page:6577-6589
ISSN:0277-6715
Container-title:Statistics in Medicine
language:en
Short-container-title:Statistics in Medicine

Author:

Wang Chenguang¹^ORCID,Rosner Gary L.¹,Bao Tingting²,Lu Nelson³,Chen Wei‐Chen³,Li Heng³,Tiwari Ram³,Xu Yunling³,Yue Lilly Q.³

Affiliation:

1. Oncology Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center Johns Hopkins University Baltimore Maryland USA

2. Data Science Institute, Fu Foundation School of Engineering and Applied Science Columbia University New York New York USA

3. Division of Biostatistics, Center for Devices and Radiological Health U.S. Food and Drug Administration Silver Spring Maryland USA

Funder

U.S. Food and Drug Administration

National Cancer Institute

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/sim.9199

Reference25 articles.

1. FDA.Part 860: medical device classification procedures (21 CFR 860.7).Federal Register.1993;1.

2. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease

3. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia

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1. Lifecycle extension of single-use medical device sensors: Case study of an engineering sustainability transition program;Journal of Cleaner Production;2023-10

2. Discussion of “target estimands for population‐adjusted indirect comparisons” by Antonio Remiro‐Azocar;Statistics in Medicine;2022-11-17

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