Works by Yue, Lilly Q.

Results: 28

Rejoinder to Letter to the Editor—Selecting an Optimal Design for a Nonrandomized Comparative Study: A Commentary on "Some Considerations on Design and Analysis Plan on a Nonrandomized Comparative Study Utilizing Propensity Score Methodology for Medical Device Premarket Evaluation"

Published in:

2022

By:

Lu, Nelson;
Xu, Yunling;
Yue, Lilly Q.

Publication type:

Letter

Mitigating Study Power Loss Caused by Clinical Trial Disruptions Due to the COVID-19 Pandemic: Leveraging External Data via Propensity Score-Integrated Approaches.

Published in:

Statistics in Biopharmaceutical Research, 2022, v. 14, n. 1, p. 87, doi. 10.1080/19466315.2020.1860813

By:

Li, Heng;
Chen, Wei-Chen;
Lu, Nelson;
Song, Changhong;
Wang, Chenguang;
Tiwari, Ram;
Xu, Yunling;
Yue, Lilly Q.

Publication type:

Article

Some Considerations on Design and Analysis Plan on a Nonrandomized Comparative Study Using Propensity Score Methodology for Medical Device Premarket Evaluation.

Published in:

Statistics in Biopharmaceutical Research, 2020, v. 12, n. 2, p. 155, doi. 10.1080/19466315.2019.1647873

By:

Lu, Nelson;
Xu, Yunling;
Yue, Lilly Q.

Publication type:

Article

Leveraging Real-World Evidence Derived from Patient Registries for Premarket Medical Device Regulatory Decision-Making.

Published in:

Statistics in Biopharmaceutical Research, 2018, v. 10, n. 2, p. 98, doi. 10.1080/19466315.2017.1422436

By:

Yue, Lilly Q.

Publication type:

Article

A Note on Good Practice of Objective Propensity Score Design for Premarket Nonrandomized Medical Device Studies with an Example.

Published in:

Statistics in Biopharmaceutical Research, 2016, v. 8, n. 3, p. 282, doi. 10.1080/19466315.2016.1148071

By:

Li, Heng;
Mukhi, Vandana;
Lu, Nelson;
Xu, Yun-Ling;
Yue, Lilly Q.

Publication type:

Article

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

Published in:

Statistics in Medicine, 2021, v. 40, n. 29, p. 6577, doi. 10.1002/sim.9199

By:

Wang, Chenguang;
Rosner, Gary L.;
Bao, Tingting;
Lu, Nelson;
Chen, Wei‐Chen;
Li, Heng;
Tiwari, Ram;
Xu, Yunling;
Yue, Lilly Q.

Publication type:

Article

Propensity score-integrated approach to survival analysis: leveraging external evidence in single-arm studies.

Published in:

Journal of Biopharmaceutical Statistics, 2022, v. 32, n. 3, p. 400, doi. 10.1080/10543406.2022.2080701

By:

Chen, Wei-Chen;
Lu, Nelson;
Wang, Chenguang;
Li, Heng;
Song, Changhong;
Tiwari, Ram;
Xu, Yunling;
Yue, Lilly Q.

Publication type:

Article

Propensity score-integrated power prior approach for augmenting the control arm of a randomized controlled trial by incorporating multiple external data sources.

Published in:

Journal of Biopharmaceutical Statistics, 2022, v. 32, n. 1, p. 158, doi. 10.1080/10543406.2021.1998098

By:

Lu, Nelson;
Wang, Chenguang;
Chen, Wei-Chen;
Li, Heng;
Song, Changhong;
Tiwari, Ram;
Xu, Yunling;
Yue, Lilly Q.

Publication type:

Article

Leverage multiple real-world data sources in single-arm medical device clinical studies.

Published in:

Journal of Biopharmaceutical Statistics, 2022, v. 32, n. 1, p. 107, doi. 10.1080/10543406.2021.1897994

By:

Lu, Nelson;
Wang, Chenguang;
Chen, Wei-Chen;
Li, Heng;
Song, Changhong;
Tiwari, Ram;
Xu, Yunling;
Yue, Lilly Q.

Publication type:

Article

Evaluation of diagnostic tests for low prevalence diseases: a statistical approach for leveraging real-world data to accelerate the study.

Published in:

Journal of Biopharmaceutical Statistics, 2021, v. 31, n. 3, p. 375, doi. 10.1080/10543406.2021.1877724

By:

Chen, Wei-Chen;
Li, Heng;
Wang, Chenguang;
Lu, Nelson;
Song, Changhong;
Tiwari, Ram;
Xu, Yunling;
Yue, Lilly Q.

Publication type:

Article

Propensity score-integrated composite likelihood approach for augmenting the control arm of a randomized controlled trial by incorporating real-world data.

Published in:

Journal of Biopharmaceutical Statistics, 2020, v. 30, n. 3, p. 508, doi. 10.1080/10543406.2020.1730877

By:

Chen, Wei-Chen;
Wang, Chenguang;
Li, Heng;
Lu, Nelson;
Tiwari, Ram;
Xu, Yunling;
Yue, Lilly Q.

Publication type:

Article

Propensity score-integrated composite likelihood approach for incorporating real-world evidence in single-arm clinical studies.

Published in:

Journal of Biopharmaceutical Statistics, 2020, v. 30, n. 3, p. 495, doi. 10.1080/10543406.2019.1684309

By:

Wang, Chenguang;
Lu, Nelson;
Chen, Wei-Chen;
Li, Heng;
Tiwari, Ram;
Xu, Yunling;
Yue, Lilly Q.

Publication type:

Article

Homogeneity assessment for pivotal medical device clinical studies.

Published in:

Journal of Biopharmaceutical Statistics, 2019, v. 29, n. 5, p. 749, doi. 10.1080/10543406.2019.1657131

By:

Yan, Xu;
Ahn, Chul;
Chu, Jianxiong;
Dong, Li Ming;
Li, Heng;
Li, Xuefeng;
Lu, Hong;
Lu, Nelson;
Mukhi, Vandana;
Nair, Rajesh;
Tiwari, Ram;
Xu, Yunling;
Yue, Lilly Q.

Publication type:

Article

Propensity score-integrated power prior approach for incorporating real-world evidence in single-arm clinical studies.

Published in:

Journal of Biopharmaceutical Statistics, 2019, v. 29, n. 5, p. 731, doi. 10.1080/10543406.2019.1657133

By:

Wang, Chenguang;
Li, Heng;
Chen, Wei-Chen;
Lu, Nelson;
Tiwari, Ram;
Xu, Yunling;
Yue, Lilly Q.

Publication type:

Article

Good statistical practice in utilizing real-world data in a comparative study for premarket evaluation of medical devices.

Published in:

Journal of Biopharmaceutical Statistics, 2019, v. 29, n. 4, p. 580, doi. 10.1080/10543406.2019.1632880

By:

Lu, Nelson;
Xu, Yunling;
Yue, Lilly Q.

Publication type:

Article

Utilizing national and international registries to enhance pre-market medical device regulatory evaluation.

Published in:

Journal of Biopharmaceutical Statistics, 2016, v. 26, n. 6, p. 1136, doi. 10.1080/10543406.2016.1226336

By:

Yue, Lilly Q.;
Campbell, Gregory;
Lu, Nelson;
Xu, Yunling;
Zuckerman, Bram

Publication type:

Article

Statistical innovations in diagnostic device evaluation.

Published in:

Journal of Biopharmaceutical Statistics, 2016, v. 26, n. 6, p. 1067, doi. 10.1080/10543406.2016.1226332

By:

Yu, Tinghui;
Li, Qin;
Gray, Gerry;
Yue, Lilly Q.

Publication type:

Article

A conversation with Dr. Greg Campbell.

Published in:

2016

By:

Liu, Aiyi;
Yue, Lilly Q.

Publication type:

Interview

Statistical innovations in the medical device world sparked by the FDA.

Published in:

Journal of Biopharmaceutical Statistics, 2016, v. 26, n. 1, p. 3, doi. 10.1080/10543406.2015.1092037

By:

Campbell, Gregory;
Yue, Lilly Q.

Publication type:

Article

Guest Editors’ Note: Special Issue Associated With the 2013 ASA Biopharmaceutical FDA/Industry Statistics Workshop.

Published in:

Journal of Biopharmaceutical Statistics, 2014, v. 24, n. 5, p. 965, doi. 10.1080/10543406.2014.942425

By:

Binkowitz, Bruce;
Yue, Lilly Q.

Publication type:

Article

Designing Premarket Observational Comparative Studies Using Existing Data as Controls: Challenges and Opportunities.

Published in:

Journal of Biopharmaceutical Statistics, 2014, v. 24, n. 5, p. 994, doi. 10.1080/10543406.2014.926367

By:

Yue, Lilly Q.;
Lu, Nelson;
Xu, Yunling

Publication type:

Article

A note on the sample size determination in two-period repeated measurements crossover design with application to clinical trials.

Published in:

Journal of Biopharmaceutical Statistics, 1998, v. 8, n. 4, p. 577, doi. 10.1080/10543409808835261

By:

Yue, Lilly Q.;
Roach, Paris

Publication type:

Article

Using Propensity Score Weighting to Enhance the Operating Characteristics of Power Prior in Leveraging External Data to Augment a Traditional Clinical Study.

Published in:

Pharmaceutical Statistics, 2025, v. 24, n. 2, p. 1, doi. 10.1002/pst.2471

By:

Li, Heng;
Chen, Wei‐Chen;
Wang, Chenguang;
Lu, Nelson;
Song, Changhong;
Tiwari, Ram;
Alexander, Gregory;
Xu, Yunling;
Yue, Lilly Q.

Publication type:

Article

A propensity score‐integrated approach for leveraging external data in a randomized controlled trial with time‐to‐event endpoints.

Published in:

Pharmaceutical Statistics, 2024, v. 23, n. 5, p. 645, doi. 10.1002/pst.2377

By:

Chen, Wei‐Chen;
Lu, Nelson;
Wang, Chenguang;
Li, Heng;
Song, Changhong;
Tiwari, Ram;
Xu, Yunling;
Yue, Lilly Q.

Publication type:

Article

Propensity score‐incorporated adaptive design approaches when incorporating real‐world data.

Published in:

Pharmaceutical Statistics, 2024, v. 23, n. 2, p. 204, doi. 10.1002/pst.2347

By:

Lu, Nelson;
Chen, Wei‐Chen;
Li, Heng;
Song, Changhong;
Tiwari, Ram;
Wang, Chenguang;
Xu, Yunling;
Yue, Lilly Q.

Publication type:

Article

Propensity score‐based methods for causal inference and external data leveraging in regulatory settings: From basic ideas to implementation.

Published in:

Pharmaceutical Statistics, 2023, v. 22, n. 4, p. 721, doi. 10.1002/pst.2294

By:

Li, Heng;
Yue, Lilly Q.

Publication type:

Article

Principled leveraging of external data in the evaluation of diagnostic devices via the propensity score‐integrated composite likelihood approach.

Published in:

Pharmaceutical Statistics, 2023, v. 22, n. 3, p. 547, doi. 10.1002/pst.2295

By:

Song, Changhong;
Li, Heng;
Chen, Wei‐Chen;
Lu, Nelson;
Tiwari, Ram;
Wang, Chenguang;
Xu, Yunling;
Yue, Lilly Q.

Publication type:

Article

Estimands in observational studies: Some considerations beyond ICH E9 (R1).

Published in:

Pharmaceutical Statistics, 2022, v. 21, n. 5, p. 835, doi. 10.1002/pst.2196

By:

Li, Heng;
Wang, Chenguang;
Chen, Wei‐Chen;
Lu, Nelson;
Song, Changhong;
Tiwari, Ram;
Xu, Yunling;
Yue, Lilly Q.

Publication type:

Article