29 Papers
42 Citations
Yunling Xu is an academic researcher from Center for Devices and Radiological Health. The author has contributed to research in topics: Computer science & Medicine. The author has an hindex of 7, co-authored 20 publications.
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Papers
Guest Editors' Note: Bayesian Approaches for Medical Product Evaluation—Today and Tomorrow
Xuefeng Li,Yunling Xu +1 more
TL;DR: This special issue attempts to capture some of the recent developments in Bayesian approaches in medical device evaluation in the past decade with an overview of the Bayesian device initiative by the FDA, examples of Bayesian regulatory submissions and Bayesian study reporting, and discussions on current statistical challenges.
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Leveraging real-world evidence for determining performance goals for medical device studies.
Chenguang Wang,Gary L. Rosner,Tingting Bao,Nelson Lu,Wei Chen Chen,Heng Li,Ram Tiwari,Yunling Xu,Lilly Q. Yue +8 more
TL;DR: In this paper, a new method for proposing performance goals by leveraging real-world evidence is proposed, which applies entropy balancing to address possible patient dissimilarities between the study's target patient population and existing realworld patients, and can take into account operation differences between clinical studies and realworld clinical practice.
2
Principled leveraging of external data in the evaluation of diagnostic devices via the propensity score‐integrated composite likelihood approach
Changhong Song,Heng Li,Wei-Chen Chen,Nelson Lu,Ram C. Tiwari,Chenguang Wang,Yunling Xu,Lilly Q. Yue +7 more
TL;DR: In this paper , the authors apply the outcome-free principle to separate study design and outcome data analysis and can mitigate bias due to imbalance in covariates, thereby increasing the interpretability of study results.
1
Use of Weighted Performance Goals in Prospective Single-Arm Clinical Studies Designed to Assess the Safety and Effectiveness of Medical Devices
Nelson Lu,Heng Li,Yunling Xu +2 more
TL;DR: The limitations of the current practice where weights need to be prespecified and fixed are discussed, and an alternative approach that relaxes the fixed weight requirements is proposed.
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A Two-Tier Procedure for Designing and Analyzing Medical Device Trials Conducted in US and OUS Regions for Regulatory Decision Making
Nelson Lu,Yunling Xu,Gerry Gray +2 more
- 01 Jan 2015
TL;DR: This chapter proposes a two-tier procedure for analyzing data from clinical trials for the US regulatory agency’s decision making, allowing treatment effects to vary from region to region.
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