Margaret Gamalo (Margaret Gamalo-Siebers)

Publication Activity (10 Years)

Years Active: 2017-2023
Publications (10 Years): 24

Top Topics

Acinetobacter Baumannii

Top Venues

Journal of biopharmaceutical statistics

Pharmaceutical statistics

Therapeutic innovation & regulatory science

This page only lists publications with an associated author ORCID identifier.

Publications

Sirui Zheng, Duo-Lao Wang, Junshan Qiu, Tao Chen, Margaret Gamalo
A win ratio approach for comparing crossing survival curves in clinical trials. Journal of biopharmaceutical statistics (2023)
Margaret Gamalo, Yihua Zhao, Aijun Gao, Jingjing Ye, Junjing Lin, Eiji Eshida, YounJeong Choi, Robert Nelson
Extent of safety database in pediatric drug development: types of assessment, analytical precision, and pathway for extrapolation through on-target effects. Journal of biopharmaceutical statistics (2023)
Jingjing Ye, Vickie Zhang, Foteini Strimenopoulou, Yihua Zhao, Haitao Pan, Mayadah Shabbout, Margaret Gamalo
Recent Use of Pediatric Extrapolation in Pediatric Drug Development in US. Journal of biopharmaceutical statistics (2023)
Margaret Gamalo, Yoonji Kim, Fan Zhang, Junjing Lin
Composite Likelihoods with Bounded Weights in Extrapolation of Data. Journal of biopharmaceutical statistics (2023)
Gaohong Dong, David C Hoaglin, Bo Huang, Ying Cui, Duolao Wang, Yu Cheng, Margaret Gamalo
The stratified win statistics (win ratio, win odds, and net benefit). Pharmaceutical statistics (2023)
Bernard Sebastien, S Y Amy Cheung, Solange Corriol-Rohou, Margaret Gamalo, Rana Jreich, Rajesh Krishna, Jing Liu
Use of pharmacodynamic modeling for Bayesian information borrowing in pediatric clinical trials. Journal of biopharmaceutical statistics (2022)
Junjing Lin, Ran Liao, Margaret Gamalo
Dynamic incorporation of real world evidence within the framework of adaptive design. Journal of biopharmaceutical statistics (2022)
James Song, Johan Verbeeck, Bo Huang, David C Hoaglin, Margaret Gamalo, Yodit Seifu, Duo-Lao Wang, Freda Cooner, Gaohong Dong
The win odds: statistical inference and regression. Journal of biopharmaceutical statistics (2022)
Rima Izem, Joan Buenconsejo, Ruthanna Davi, Jingyu Julia Luan, LaRee Tracy, Margaret Gamalo
Real-World Data as External Controls: Practical Experience from Notable Marketing Applications of New Therapies. Therapeutic innovation & regulatory science 56 (5) (2022)
Yodit Seifu, Shahrul Mt-Isa, Kyle Duke, Margaret Gamalo, William Wang, Gaohong Dong, John Kolassa
Design of paediatric trials with benefit-risk endpoints using a composite score of adverse events of interest (AEI) and win-statistics. Journal of biopharmaceutical statistics (2022)
Ran Liao, Sujatro Chakladar, Margaret Gamalo
Win ratio approach for analyzing composite time-to-event endpoint with opposite treatment effects in its components. Pharmaceutical statistics 21 (6) (2022)
Bernard Sebastien, S Y Amy Cheung, Solange Corriol-Rohou, Margaret Gamalo, Rana Jreich, Rajesh Krishna, Jing Liu
Use of pharmacodynamic modeling for Bayesian information borrowing in pediatric clinical trials. Journal of biopharmaceutical statistics (2022)
Margaret Gamalo, Christina Bucci-Rechtweg, Robert M Nelson, Linh Vanh, Ariel Porcalla, Helen Thackray, Freda Cooner, Lauren Cutler, Danielle Friend, Ron Portman
Extrapolation as a Default Strategy in Pediatric Drug Development. Therapeutic innovation & regulatory science 56 (6) (2022)
Junjing Lin, Guanglei Yu, Margaret Gamalo
Matching within a hybrid RCT/RWD: framework on associated causal estimands. Journal of biopharmaceutical statistics (2022)
Guanglei Yu, Yuanyuan Bian, Margaret Gamalo
Power priors with entropy balancing weights in data augmentation of partially controlled randomized trials. Journal of biopharmaceutical statistics 32 (1) (2022)
YounJeong Choi, Nathalie Barbier, Sabine Fürst-Recktenwald, Jingjing Ye, Dalia Ballas Wajsbrot, Eiji Ishida, Margaret Gamalo
Analysis and reporting of pediatric growth and development assessment from clinical trials: overview and challenges. Journal of biopharmaceutical statistics (2022)
Gaohong Dong, Bo Huang, Johan Verbeeck, Ying Cui, James Song, Margaret Gamalo, Duolao Wang, David C Hoaglin, Yodit Seifu, Tobias Mütze, John Kolassa
Win statistics (win ratio, win odds, and net benefit) can complement one another to show the strength of the treatment effect on time-to-event outcomes. Pharmaceutical statistics (2022)
Junjing Lin, Margaret Gamalo, Ram Tiwari
Ensuring exchangeability in data-based priors for a Bayesian analysis of clinical trials. Pharmaceutical statistics (2021)
Sujatro Chakladar, Ran Liao, Margaret Gamalo
Estimands, Handling of Missing Data and Impact on Assumed Effect Size and Power in Pivotal COVID-19 Treatment Trials. Journal of biopharmaceutical statistics (2021)
Kathleen M Job, Margaret Gamalo, Robert M Ward
Pediatric Age Groups and Approach to Studies. Therapeutic innovation & regulatory science 53 (5) (2019)
Margaret Gamalo, Lisa Hampson, Kattayoun Kordy, Sebastian Weber, Robert M Nelson, Ronald Portman
Incorporating Innovative Techniques Toward Extrapolation and Efficient Pediatric Drug Development. Therapeutic innovation & regulatory science 53 (5) (2019)
Junjing Lin, Margaret Gamalo, Ram Tiwari
Propensity-score-based priors for Bayesian augmented control design. Pharmaceutical statistics 18 (2) (2018)
Junjing Lin, Margaret Gamalo, Ram Tiwari
Propensity score matched augmented controls in randomized clinical trials: A case study. Pharmaceutical statistics 17 (5) (2018)
Margaret Gamalo, Jasmina Savic, Cynthia Basu, Xin Zhao, Mathangi Gopalakrishnan, Aijun Gao, Guochen Song, Simin Baygani, Laura Thompson, H Amy Xia, Karen Price, Ram Tiwari, Bradley P Carlin
Statistical modeling for Bayesian extrapolation of adult clinical trial information in pediatric drug evaluation. Pharmaceutical statistics 16 (4) (2017)