Paper Review Records
All Paper Review Records
20 valid samples · Newest publication first
Review days = acceptance date − received date. PDF, DOI, and publisher-page sources are retained.
The Impact of Enrollment Strategies on the Performance of Time‐To‐Event Dose‐Escalation Designs for Phase I Drug Combination Oncology Trials
AuthorsXiaowen Tian; Michael Sweeting; Kristine Broglio
Affiliations1. Oncology Biometrics, Oncology R&D AstraZeneca Gaithersburg Maryland USA; 2. Oncology Biometrics, Oncology R&D AstraZeneca Cambridge UK
Hierarchical Composite Endpoints for Dose Optimization in Early Phase Oncology Trials
AuthorsYuxiang Wu; Xiaohan Guo; Ray Li; Christophe Le Corre
Affiliations1. Department of Biostatistics and Bioinformatics Emory University Atlanta Georgia USA; 2. Oncology Biometrics Pfizer New York New York USA
Use of Composite Priors for Assurance of Sequential Therapy Trials: Practical Experiences Using Binary Endpoint Data
AuthorsJonathan Wright; Li Ye
Affiliations1. GSK London UK; 2. GSK Upper Providence Pennsylvania USA
Applying the Promising Zone Method to Biomarker‐Based Adaptive Designs: A Word of Caution
AuthorsJingzhao Wang; Ruobing Li; Jun Zhao; Zhimin Tang; Jianhong Pan
Affiliations1. Office of Biostatistics and Clinical Pharmacology, Center for Drug Evaluation National Medical Products Administration Beijing China
Accelerated Stability Studies: A Frequentist–Bayesian Hybrid Simulation Approach Implemented in the AccelStab R Package
AuthorsBernard G. Francq; Nikolaos Giannelos; Raymundo Sanchez; Marilena Paludi
Affiliations1. GSK Rixensart Belgium; 2. GSK Collegeville Pennsylvania USA; 3. GSK Siena Italy
Robustness of the Pairwise‐Fitting Approach Under Missing at Random Dropout: A Case and Simulation Study
AuthorsDries De Witte; Geert Verbeke; Thomas Neyens; Ariel Alonso Abad; Geert Molenberghs
Affiliations1. L‐BioStat, KU Leuven Leuven Belgium; 2. I‐BioStat, UHasselt Diepenbeek Belgium
Degrees‐of‐Freedom Approximations for Conditional‐Mean Inference in Random‐Lot Stability Analysis
AuthorsAndrew T. Karl; Heath Rushing; Richard K. Burdick; Jeff Hofer
Affiliations1. Karl Statistical Services LLC Aurora Colorado USA; 2. Adsurgo LLC San Antonio Texas USA; 3. Burdick Statistical Consulting, LLC Colorado Springs Colorado USA; 4. JDH CMC Stats, LLC Avon Indiana USA
Seamless Phase I– II Cancer Clinical Trials Using Kernel‐Based Covariate Similarity
AuthorsKana Makino; Natsumi Makigusa; Masahiro Kojima
Affiliations1. Department of Data Science for Business Innovation Chuo University Tokyo Japan
A Cautionary Note on Regional Consistency Evaluation With Multiple Primary Endpoints in Multiregional Clinical Trials
AuthorsGosuke Homma
Affiliations1. Astellas Pharma Inc. Tokyo Japan
Dose Optimization Design for Randomized Phase II Trials With Toxicity and Efficacy Endpoints
AuthorsRyuta Tabata; Tomohiro Ohigashi; Takashi Sozu
Affiliations1. Department of Information and Computer Technology, Graduate School of Engineering Tokyo University of Science Tokyo Japan; 2. Department of Information and Computer Technology, Faculty of Engineering Tokyo University of Science Tokyo Japan
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