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Pembrolizumab versus Chemotherapy for PD-L1–Positive Non–Small-Cell Lung Cancer

The New England journal of medicine, 2016-11, Vol.375 (19), p.1823-1833

2016

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Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial

The Lancet (British edition), 2016-04, Vol.387 (10027), p.1540-1550

2016

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Effects of MK-0941, a Novel Glucokinase Activator, on Glycemic Control in Insulin-Treated Patients With Type 2 Diabetes

Diabetes care, 2011-12, Vol.34 (12), p.2560-2566

2011

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Adaptive Informational Design of Confirmatory Phase III Trials With an Uncertain Biomarker Effect to Improve the Probability of Success

Statistics in biopharmaceutical research, 2016-07, Vol.8 (3), p.237-247

2016

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Consistency assessment with global and bridging development strategies in emerging markets

Contemporary clinical trials, 2013-11, Vol.36 (2), p.687-696

2013

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Auto-adaptive Alpha Allocation: A Strategy to Mitigate Risk on Study Assumptions

Statistics in biosciences, 2018-08, Vol.10 (2), p.342-356

2018

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Relationship between level of PD-L1 expression and outcomes in the KEYNOTE-010 study of pembrolizumab vs docetaxel for previously treated, PD-L1–Positive NSCLC

Journal of clinical oncology, 2016-05, Vol.34 (15_suppl), p.9015-9015

2016

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P2.41 (also presented as PD1.06): Pembrolizumab vs Docetaxel for Previously Treated NSCLC (KEYNOTE-010): Archival vs New Tumor Samples for PD-L1 Assessment

Journal of thoracic oncology, 2016-10, Vol.11 (10), p.S242-S243

2016

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A note on dichotomization of continuous response variable in the presence of contamination and model misspecification

Statistics in medicine, 2010-09, Vol.29 (21), p.2200-2214

2010

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A nonparametric method for value function guided subgroup identification via gradient tree boosting for censored survival data

Statistics in medicine, 2020-12, Vol.39 (28), p.4133-4146

2020

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Covariate-adjusted value-guided subgroup identification via boosting

Journal of biopharmaceutical statistics, 2023-11, p.1-18

2023

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Clinical Trial Data Analysis Using R

Journal of statistical software, 2011, Vol.43 (Book Review 1)

Shentu, Yue

2011

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Value Function Guided Subgroup Identification via Gradient Tree Boosting: A Framework to Handle Multiple Outcomes for Optimal Treatment Recommendation

Statistics in biopharmaceutical research, 2022-10, Vol.14 (4), p.523-531

2022

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Principal stratum strategy: Potential role in drug development

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2021-07, Vol.20 (4), p.737-751

2021

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Genetic structures of copy number variants revealed by genotyping single sperm

PloS one, 2009-04, Vol.4 (4), p.e5236-e5236

2009

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Independent drug action and its statistical implications for development of combination therapies

Contemporary clinical trials, 2020-11, Vol.98, p.106126-106126, Article 106126

2020

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Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic

Statistics in biopharmaceutical research, 2020-10, Vol.12 (4), p.399-411

2020

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Assessing the Impact of COVID-19 on the Clinical Trial Objective and Analysis of Oncology Clinical Trials-Application of the Estimand Framework

Statistics in biopharmaceutical research, 2020-10, Vol.12 (4), p.427-437

2020

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Rationale and Design of the Phase III KEYLYNK-012 Study of Pembrolizumab and Concurrent Chemoradiotherapy Followed by Pembrolizumab With or Without Olaparib for Stage III Non-Small-Cell Lung Cancer

Clinical lung cancer, 2022-09, Vol.23 (6), p.e342-e346

2022

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Information-based sample size re-estimation in group sequential design for longitudinal trials

Statistics in medicine, 2014-09, Vol.33 (22), p.3801-3814

2014

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From Logic-Respecting Efficacy Estimands to Logic-Ensuring Analysis Principle for Time-to-Event Endpoint in Randomized Clinical Trials with Subgroups

Statistics in biopharmaceutical research, 2023-07, Vol.15 (3), p.560-573

2023

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Estimands for overall survival in clinical trials with treatment switching in oncology

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2022-01, Vol.21 (1), p.150-162

2022

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Phase 3 study of carboplatin-paclitaxel/nab-paclitaxel (Chemo) with or without pembrolizumab (Pembro) for patients (Pts) with metastatic squamous (Sq) non-small cell lung cancer (NSCLC)

Journal of clinical oncology, 2018-05, Vol.36 (15_suppl), p.105-105

2018

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Progression after the next line of therapy (PFS2) and updated OS among patients (pts) with advanced NSCLC and PD-L1 tumor proportion score (TPS) ≥50% enrolled in KEYNOTE-024

Journal of clinical oncology, 2017-05, Vol.35 (15_suppl), p.9000-9000

2017

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Efficacy and Tolerability of Sitagliptin Compared with Glimepiride in Elderly Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control: A Randomized, Double-Blind, Non-Inferiority Trial

Drugs & aging, 2015-06, Vol.32 (6), p.469-476

2015

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Pembrolizumab versus Chemotherapy for PD-L1–Positive Non–Small-Cell Lung Cancer

Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial

Effects of MK-0941, a Novel Glucokinase Activator, on Glycemic Control in Insulin-Treated Patients With Type 2 Diabetes

Adaptive Informational Design of Confirmatory Phase III Trials With an Uncertain Biomarker Effect to Improve the Probability of Success

Consistency assessment with global and bridging development strategies in emerging markets

Auto-adaptive Alpha Allocation: A Strategy to Mitigate Risk on Study Assumptions

Relationship between level of PD-L1 expression and outcomes in the KEYNOTE-010 study of pembrolizumab vs docetaxel for previously treated, PD-L1–Positive NSCLC

P2.41 (also presented as PD1.06): Pembrolizumab vs Docetaxel for Previously Treated NSCLC (KEYNOTE-010): Archival vs New Tumor Samples for PD-L1 Assessment

A note on dichotomization of continuous response variable in the presence of contamination and model misspecification

A nonparametric method for value function guided subgroup identification via gradient tree boosting for censored survival data

Covariate-adjusted value-guided subgroup identification via boosting

Clinical Trial Data Analysis Using R

Value Function Guided Subgroup Identification via Gradient Tree Boosting: A Framework to Handle Multiple Outcomes for Optimal Treatment Recommendation

Principal stratum strategy: Potential role in drug development

Genetic structures of copy number variants revealed by genotyping single sperm

Independent drug action and its statistical implications for development of combination therapies

Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic

Assessing the Impact of COVID-19 on the Clinical Trial Objective and Analysis of Oncology Clinical Trials-Application of the Estimand Framework

Rationale and Design of the Phase III KEYLYNK-012 Study of Pembrolizumab and Concurrent Chemoradiotherapy Followed by Pembrolizumab With or Without Olaparib for Stage III Non-Small-Cell Lung Cancer

Information-based sample size re-estimation in group sequential design for longitudinal trials

From Logic-Respecting Efficacy Estimands to Logic-Ensuring Analysis Principle for Time-to-Event Endpoint in Randomized Clinical Trials with Subgroups

Estimands for overall survival in clinical trials with treatment switching in oncology

Phase 3 study of carboplatin-paclitaxel/nab-paclitaxel (Chemo) with or without pembrolizumab (Pembro) for patients (Pts) with metastatic squamous (Sq) non-small cell lung cancer (NSCLC)

Progression after the next line of therapy (PFS2) and updated OS among patients (pts) with advanced NSCLC and PD-L1 tumor proportion score (TPS) ≥50% enrolled in KEYNOTE-024

Efficacy and Tolerability of Sitagliptin Compared with Glimepiride in Elderly Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control: A Randomized, Double-Blind, Non-Inferiority Trial

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