Publications
Publications
D. Montani, V. V McLaughlin, J S. R Gibbs, M. Gomberg-Maitland, M. M Hoeper, I. R Preston, R. Souza, A. B Waxman, P. Escribano Subias, J. Feldman, G. M Meyer, K. M Olsson, F. Coulet, S. Manimaran, Y. Zhao, A. Lau, J. de Oliveira Pena, D. B Badesch, M. Humbert. Consistent Safety and Efficacy of Sotatercept for Pulmonary Arterial Hypertension in BMPR2 Mutation Carriers and Noncarriers: A Planned Analysis of Phase 2, Double-Blind, Placebo-controlled Clinical Trial (PULSAR). American Journal of Respiratory and Critical Care Medicine (2025). [paper]
Y. Zhao, Q. Liu, L. Sun, K. Anderson. Adjusted Inference for Multiple Testing Procedures in Group sequential designs. Biometrical journal (2025). [paper]
Y. Zhao, Y. Zhang, K. Anderson. Group Sequential Design Under Non-proportional Hazards: Methodologies and Examples. Biostatistics in Biopharmaceutical Research and Development: Clinical Trial Design, Volume 1 (2024). [book chapter]
Q. Liu, Y. Zhao, J. Zhao. Multiple Testing in Group Sequential Design. Biostatistics in Biopharmaceutical Research and Development: Clinical Trial Design, Volume 1 (2024). [book chapter]
C. H. Yoon, M. I. Ross, B. R. Gastman, J. J. Luke, P. A. Ascierto, G. V. Long, P. Rutkowski, M. Khattak, M. D. Vecchio, L. C. Merino, J. Mackiewicz, V. Chiarion-Sileni, D. Schadendorf, M. S. Carlino, Y. Zhao, M. Fukunaga-Kalabis, C. Krepler, A. M. M. Eggermont, J. E. Gershenwald, V. K. Sondak. Adjuvant Pembrolizumab in Stage II Melanoma: Outcomes by Primary Tumor Location in the Randomized, Double-Blind, Phase III KEYNOTE-716 Trial. Accepted by Annals of Surgical Oncology (2025).
P. H. O’Donnell, Y. Loriot, T. Csoszi, N. Matsubara, S. J. Shin, S. H. Park, V. Atduev, M. Gumus, S. B. Karaca, P. Grivas, R. de Wit, D. E. Castellano, T. Powles, J. Vuky, Y. Zhao, K. O’Hara, C. E. Okpara, S. Franco. Efficacy and safety of pembrolizumab in patients with advanced urothelial carcinoma deemed potentially ineligible for platinum-containing chemotherapy: Post hoc analysis of KEYNOTE-052 and LEAP-011. Cancer (2024). [paper]
Y. Zhang, Y. Zhao, B. Wang, Y. Luo. Number of Repetitions in Re-Randomization Tests. Pharmaceutical Statistics (2024). [paper]
V. S. Sridhar, F. Cosentino, S. Dagogo-Jack, D. K. McGuire, R. E Pratley, N. B. Cater, M. N. Essex, J. P Mancuso, Y. Zhao, David. Cherney. Effects of ertugliflozin on uric acid and gout‐related outcomes in persons with type 2 diabetes and cardiovascular disease: Post hoc analyses from VERTIS CV. Diabetes, Obesity and Metabolism (2024). [paper]
J. J. Luke, G. V. Long, C. Robert, M. S. Carlino, T. K. Choueiri, N. B. Haas, M. O'Brien, L. Paz-Ares, S. Peters, T. Powles, M. A Leiby, J. Lin, Y. Zhao, C. Krepler, R. F. Perini, M. C. Pietanza, A. Samkari, T. Gruber, N. Ibrahim, A. M. M. Eggermont. Safety of pembrolizumab as adjuvant therapy in a pooled analysis of phase 3 clinical trials of melanoma, non-small cell lung cancer, and renal cell carcinoma. European Journal of Cancer (2024). [paper]
K. M. Anderson, Y. Zhao, N. Xiao, J. Ge, H. F. Weisman. Some group sequential trials from industry over the last 30 years. Statistics in Biopharmaceutical Research (2024). [paper]
S. M. Patel, Y. Mi Kang, K. Im, B. L Neuen, S. D Anker, D. L Bhatt, J. Butler, D. Z I Cherney, B. L Claggett, R. A Fletcher, W. G Herrington, S. E Inzucchi, M. J Jardine, K. W Mahaffey, D. K McGuire, J. J V McMurray, B. Neal, M. Packer, V. Perkovic, S.D Solomon, N. Staplin, M. Vaduganathan, C. Wanner, D. C Wheeler, F. Zannad, Y. Zhao, H. J L Heerspink, M. S Sabatine, S. D Wiviott. Sodium Glucose Co-transporter 2 Inhibitors and Major Adverse Cardiovascular Outcomes: A SMART-C Collaborative Meta-Analysis. Circulation (2024). [paper]
D. Schadendorf, J. J. Luke, P. A. Ascierto, G. V. Long, P. Rutkowski, A. Khattak, M. Del Vecchio, L. de la Cruz-Merino, J. Mackiewicz, V. Chiarion Sileni, J. M. Kirkwood, C. Robert, J. Grob, R. Dummer, M. S Carlino, Y. Zhao, M. Kalabis, C. Krepler, A. Eggermont, and R. A Scolyer. Pembrolizumab versus placebo as adjuvant therapy in resected stage IIB or IIC melanoma: Outcomes in histopathologic subgroups from the randomized, double-blind, phase 3 KEYNOTE-716 trial. Journal for Immunotherapy of Cancer (2024). [paper]
Y. Guan, A. Puenpatom,M.G. Johnson, Y. Zhang, Y. Zhao, J. Surber, A. Weinberg, C. Brotons, R. Kozlov, R. Lopez, K. Coetzee, J. Santiaguel, J. Du, A. Williams-Diaz, M. Brown, A. Paschke, C. De Anda, and J.M. Norquist. Impact of Molnupiravir Treatment on PatientReported COVID-19 Symptoms in the Phase 3 MOVe-OUT Trial: A Randomized, Placebo Controlled Trial. Clinical Infectious Diseases (2023). [paper]
Y. Zhao, X. Huo. Accelerate the Warm-up Stage in the Lasso Computation via a Homotopic Approach. Computational Statistics and Data Analysis (2023). [paper]
Y. Zhao, X. Huo, Y. Mei. Identification of Partial-Differential-Equations-Based Models from Noisy Data via Splines. Statistical Sinica (2023). [paper]
J. J. Luke; G. V. Long; C. Robert; M. S. Carlino; T. K. Choueiri; N. B. Haas; M. O’Brien; L. Paz-Ares; S. Peters; T. Powles; M. A. Leiby; J. Lin; Y. Zhao; C. Krepler; R. F. Perini; M. C. Pietanza; A. Samkari; T. Gruber; N. Ibrahim; A. M. M. Eggermont. 76P Safety profile of adjuvant pembrolizumab (pembro) in melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC): Pooled analysis of phase III clinical trials." Immuno-Oncology and Technology 16 (2022). [paper]
Y. Zhao, X. Huo. A survey of numerical algorithms that can solve the Lasso problems. WIREs Computational Statistics (2022). [paper]
Y. Zhao, N. Xiao, K. Anderson, Y. Zhang. Electronic common technical document submission with analysis using R. Clinical Trials (2022). [paper].
Y. Zhao, X. Huo, Y. Mei. Hot-spots Detection in Count Data by Poisson assisted Smooth Sparse Tensor Decomposition. Journal of Applied Statistics (2022). [paper]
Y. Loriot, T. Csoszi, N. Matsubara, S.J. Shin, S.H. Park, V. Atduev, M. Gumus, B.B. Karaca, P. Grivas, R. De Wit, A.O. Siefker-Radtke, D.E. Castellano Gauna, P.H. O’Donnell, T.B. Powles, J. Vuky, Y. Zhao, K.O’hara, S. Franco, B. Homet Moreno, J. Zolnierek. 1752P Post hoc analysis of pembrolizumab efficacy in potentially platinum ineligible patients with urothelial carcinoma enrolled in KEYNOTE-052 and LEAP-011. Annals of Oncology (2022). [paper]
Y. Zhao, H. Yan, S.E. Holte, Y. Mei. "Rapid detection of hot-spots via tensor decomposition with applications to crime rate data." Journal of Applied Statistics (2021). [paper]
Y. Zhao. "New progress in hot-spots detection, partial-differential-equation-based model identification and statistical computation." PhD thesis., Georgia Institute of Technology, 2021. [paper]
Y. Zhao, H. Yan, S.E. Holte, R.P. Kerani, Y. Mei. "Rapid Detection of Hot-spot by Tensor Decomposition with Application to Weekly Gonorrhea Data." XIITH International Workshop on Intelligent Statistical Quality Control, pp. 265-286. Springer, Cham, 2019. [paper]
Y. Zhao. "The appreciation of statistical thoughts." Statistical Theory and Related Fields 3, no. 1 (2019): 83-84. [paper]
Presentations/Posters at Statistical Conferences
2024/09: Impact of Informative Censoring on Estimation and Testing under Delayed Treatment Effects. @2024 The ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop, Rockville, MD, US.
2024/09: Update Efficacy and Futility Boundaries at the Time of Analysis under Non-proportional Hazards. @2024 The ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop, Rockville, MD, U.S.
2023/03: Number of Repetitions in Re-randomization Tests. @2023 Statistical Practice in Cancer Conference, Tampa, FL, US.
2022/10: Using Metadata for Speedy Delivery @The R Adoption Series, virtual. [video]
2022/09: Number of Repetitions in Re-randomization Tests @ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop, Rockville, MD, US.
2021/11: Interactive Forest Plot of Adverse Events for DMC Monitoring @R/Pharma, virtual. [video]
2021/10: Recovery of Underlying Identification of Partial-Differential-Equations-Based Models from Noisy Data via Splines @INFORMS, virtual.
2019/09: Rapid Detection of Hot-spot by Tensor Decomposition with Application to Weekly Gonorrhea Data. @57th Annual Allerton Conference on Communication, Control, and Computing, Monticello, IL, US.
2019/10: Rapid Detection of Hot-spot by Tensor Decomposition with Application to Weekly Gonorrhea Data @INFORMS, Seattle, WA, US.
2018/10: Detection of Hot-spots via Tensor Decomposition with Applications to Crime Rate @Algorithms for Threat Detection, Washington D.C., US.
Co-authored Abstracts/Presentations/Posters at Clinical Conferences
2023/11: [Abstract] Effects of Ertugliflozin by Uric Acid Quintile: Observations From VERTIS CV. @2023 American Society of Nephrology (ASN), Philadelphia, PA, US.
2023/10: [Abstract] Cardiovascular risk assessment after continuing or switching to a doravirine-based regimen using the atherosclerotic cardiovascular disease (ASCVD) risk score model. @European AIDS Conference, Warsaw, Poland.
2023/03: [Presentation] Adjuvant Pembrolizumab in Stage II Melanoma: Outcomes by Tumor Location in the Phase 3 KEYNOTE-716 Study @2023 International Conference on Surgical Cancer Care, Boston, MA, US.
2023/05: [Abstract] Prognostic value of the multicomponent improvement (MCI) endpoint in patients with pulmonary arterial hypertension (PAH) treated with sotatercept. @2023 American Thoracic Society International Conference (ATS), Washington, DC, US.
2023/05: [Abstract] A biomarker analysis of the phase 2 randomized controlled PULSAR study of Sotatercept vs placebo for the treatment of pulmonary arterial hypertension (PAH). @2023 American Thoracic Society International Conference (ATS), Washington, DC, US.
2023/03: [Presentation] Safety of Adjuvant Pembrolizumab (pembro) in a Pooled Analysis of Phase 3 Clinical Trials in Melanoma, Non–Small Cell Lung Cancer (NSCLC), and Renal Cell Carcinoma (RCC). @International Conference on Surgical Cancer Care, Boston, MA, US.
2022/12: [Abstract] Safety profile of adjuvant pembrolizumab (pembro) in melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC): pooled analysis of phase 3 clinical trials. @2022 European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress, Geneva, Switzerland.
2022/12: [Abstract] Post hoc analysis of pembrolizumab efficacy in potentially platinum-ineligible patients with advanced urothelial carcinoma enrolled in KEYNOTE-052 and LEAP-011. @2022 European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress, Geneva, Switzerland.
2022/10: [Abstract] Adjuvant pembrolizumab (pembro) in stage II melanoma: outcomes in histopathologic subgroups in the phase 3 KEYNOTE-716 study. @2022 Society for Melanoma Research (SMR), Edinburgh, Scotland.
2022/10: [Presentation] Adjuvant pembrolizumab (pembro) in stage II melanoma: outcomes in histopathologic subgroups in the phase 3 KEYNOTE-716 study @Society for Melanoma Research, Edinburgh EH3 8EE, United Kingdom [slides]
2022/03: [Abstract] Safety of Adjuvant Pembrolizumab (pembro) in a Pooled Analysis of Phase 3 Clinical Trials in Melanoma, Non–Small Cell Lung Cancer (NSCLC), and Renal Cell Carcinoma (RCC). @2022 International Conference on Surgical Cancer Care, Dallas, TX, US.