Zobrazeno 1 - 10 of 49 pro vyhledávání: '"Lilly Q. Yue"'
2
Estimands in observational studies: Some considerations beyond ICH E9 ( R1 )
Autor: Heng Li, Chenguang Wang, Wei‐Chen Chen, Nelson Lu, Changhong Song, Ram Tiwari, Yunling Xu, Lilly Q. Yue
Publikováno v: Pharmaceutical Statistics. 21:835-844
The document ICH E9 (R1) has brought much attention to the concept of estimand in the clinical trials community. ICH stands for International Conference for Harmonization. In this article, we draw attention to one facet of estimand that is not discus
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e81afa2951d81e61c6ba0ff190cccb7f
https://doi.org/10.1002/pst.2196
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5
Propensity score-integrated power prior approach for augmenting the control arm of a randomized controlled trial by incorporating multiple external data sources
Autor: Chenguang Wang, Lilly Q. Yue, Heng Li, Ram C. Tiwari, Changhong Song, Wei-Chen Chen, Nelson Lu, Yunling Xu
Publikováno v: Journal of Biopharmaceutical Statistics. 32:158-169
In this paper, a propensity score-integrated power prior approach is developed to augment the control arm of a two-arm randomized controlled trial (RCT) with subjects from multiple external data sources such as real-world data (RWD) and historical cl
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::24d2df1a7b273881a5fdc75ac7f1b239
https://doi.org/10.1080/10543406.2021.1998098
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6
Leveraging real‐world evidence for determining performance goals for medical device studies
Autor: Tingting Bao, Ram Tiwari, Nelson Lu, Heng Li, Gary L. Rosner, Wei Chen Chen, Lilly Q. Yue, Yunling Xu, Chenguang Wang
Publikováno v: Statistics in Medicine. 40:6577-6589
Performance goals are numerical target values pertaining to effectiveness or safety endpoints in single-arm medical device clinical studies. Typically, performance goals are determined at the planning stage of the investigational study under consider
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::db4fa4ef711e89bbf028cf1222d5934c
https://doi.org/10.1002/sim.9199
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8
Leverage multiple real-world data sources in single-arm medical device clinical studies
Autor: Heng Li, Changhong Song, Lilly Q. Yue, Yunling Xu, Nelson Lu, Chenguang Wang, Wei Chen Chen, Ram Tiwari
Publikováno v: Journal of Biopharmaceutical Statistics. 32:107-123
The interest in utilizing real-world data (RWD) has been considerably increasing in medical product development and evaluation. With proper usage and analysis of high-quality real-world data, real-world evidence (RWE) can be generated to inform regul
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2184757fc219f92892466f8f70b8da64
https://doi.org/10.1080/10543406.2021.1897994
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9
Evaluation of diagnostic tests for low prevalence diseases: a statistical approach for leveraging real-world data to accelerate the study
Autor: Changhong Song, Lilly Q. Yue, Ram Tiwari, Heng Li, Yunling Xu, Chenguang Wang, Nelson Lu, Wei Chen Chen
Publikováno v: Journal of Biopharmaceutical Statistics. 31:375-390
The evaluation of diagnostic tests usually involves statistical inference for its sensitivity. As sensitivity is defined as the probability that the test result will be positive when the target condition is present, the key study design consideration
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::463b066d58412f583c1774839fbcb872
https://doi.org/10.1080/10543406.2021.1877724
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10
Mitigating Study Power Loss Caused by Clinical Trial Disruptions Due to the COVID-19 Pandemic: Leveraging External Data via Propensity Score-Integrated Approaches
Autor: Yunling Xu, Chenguang Wang, Nelson Lu, Wei Chen Chen, Ram Tiwari, Heng Li, Lilly Q. Yue, Changhong Song
Publikováno v: Statistics in Biopharmaceutical Research
The spread of COVID-19 has created tremendous challenges to ongoing clinical studies essential to finding effective treatments and cures for a myriad of diseases, with some studies having suspended...
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::09970dc47000f7f9d1cd831476e45ac0
https://doi.org/10.1080/19466315.2020.1860813
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