Works by Lu, Nelson

Results: 32

Successful treatment of suspected early form of chronic Chagas cardiomyopathy: a case report.

Published in:

European Heart Journal Case Reports, 2022, v. 6, n. 10, p. 1, doi. 10.1093/ehjcr/ytac403

By:

Lu, Nelson;
Werry, Denise;
Chapman, Michael;
Morshed, Muhammad;
Ndao, Momar;
Mirzanejad, Yazdan

Publication type:

Article

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

Use of Weighted Performance Goals in Prospective Single-Arm Clinical Studies Designed to Assess the Safety and Effectiveness of Medical Devices.

Published in:

Statistics in Biopharmaceutical Research, 2021, v. 13, n. 4, p. 504, doi. 10.1080/19466315.2020.1799853

By:

Lu, Nelson;
Li, Heng;
Xu, Yun-Ling

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

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

Acoustic Cue Integration in Speech Intonation Recognition With Cochlear Implants.

Published in:

Trends in Amplification, 2012, v. 16, n. 2, p. 67, doi. 10.1177/1084713812451159

By:

Peng, Shu-Chen;
Chatterjee, Monita;
Lu, Nelson

Publication type:

Article

Automated Atrial Fibrillation Diagnosis by Echocardiography without ECG: Accuracy and Applications of a New Deep Learning Approach.

Published in:

Diseases, 2024, v. 12, n. 2, p. 35, doi. 10.3390/diseases12020035

By:

Lu, Nelson;
Vaseli, Hooman;
Mahdavi, Mobina;
Taheri Dezaki, Fatemah;
Luong, Christina;
Yeung, Darwin;
Gin, Ken;
Tsang, Michael;
Nair, Parvathy;
Jue, John;
Barnes, Marion;
Behnami, Delaram;
Abolmaesumi, Purang;
Tsang, Teresa S. M.

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

Emerging clinical initiatives in pharmaceutical development: methodology and regulatory perspectives.

Published in:

Journal of Biopharmaceutical Statistics, 2022, v. 32, n. 3, p. 357, doi. 10.1080/10543406.2022.2080699

By:

Lu, Nelson;
Pang, Herbert

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

Incorporating a companion test into the noninferiority design of medical device trials.

Published in:

Journal of Biopharmaceutical Statistics, 2019, v. 29, n. 1, p. 143, doi. 10.1080/10543406.2018.1489403

By:

Lu, Nelson T.;
Xu, Yunling;
Yang, Ying

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

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

Decision Rules and Associated Sample Size Planning for Regional Approval Utilizing Multiregional Clinical Trials.

Published in:

Journal of Biopharmaceutical Statistics, 2012, v. 22, n. 5, p. 1001, doi. 10.1080/10543406.2012.701582

By:

Chen, Xiaoyuan;
Lu, Nelson;
Nair, Rajesh;
Xu, Yunling;
Kang, Cailian;
Huang, Qin;
Li, Ning;
Chen, Hongzhuan

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

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

Improving precision and power in randomized trials with a two‐stage study design: Stratification using clustering method.

Published in:

Pharmaceutical Statistics, 2023, v. 22, n. 2, p. 396, doi. 10.1002/pst.2279

By:

Ye, Xuan;
Lu, Nelson;
Xu, Yunling

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

Processing of Acoustic Cues in Lexical-Tone Identification by Pediatric Cochlear-Implant Recipients.

Published in:

Journal of Speech, Language & Hearing Research, 2017, v. 60, n. 5, p. 1223, doi. 10.1044/2016_JSLHR-S-16-0048

By:

Shu-Chen Peng;
Hui-Ping Lu;
Lu, Nelson;
Yung-Song Lin;
Deroche, Mickael L. D.;
Chatterjee, Monita

Publication type:

Article

Long-Term Trajectories of the Development of Speech Sound Production in Pediatric Cochlear Implant Recipients.

Published in:

Journal of Speech, Language & Hearing Research, 2008, v. 51, n. 5, p. 1353, doi. 10.1044/1092-4388(2008/07-0083)

By:

Tomblin, J. Bruce;
Shu-Chen Peng;
Spencer, Linda J.;
Lu, Nelson

Publication type:

Article

Effects of Cooperating and Conflicting Cues on Speech Intonation Recognition by Cochlear Implant Users and Normal Hearing Listeners.

Published in:

Audiology & Neurotology, 2009, v. 14, n. 5, p. 327, doi. 10.1159/000212112

By:

Shu-Chen Peng;
Lu, Nelson;
Chatterjee, Monita

Publication type:

Article