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.
Quantitative Dose Optimization for Gene Therapy Trials: Implications for Project Optimus and Early‐Phase Design
AuthorsKevin Roberts; Jeffrey Palmer; Jessica Volpe; Wei Zhong; Avery McIntosh
Affiliations1. Pfizer Inc. Cambridge Massachusetts USA; 2. Takeda Cambridge Massachusetts USA; 3. Pfizer Inc. Collegeville Pennsylvania USA
A Fast, Flexible Simulation Framework for Bayesian Adaptive Designs—The R Package BATSS
AuthorsDominique‐Laurent Couturier; Rainer Puhr; Stephane Heritier; Thomas Jaki; Elizabeth G. Ryan
Affiliations1. MRC Biostatistics Unit University of Cambridge Cambridge UK; 2. School of Public Health and Preventive Medicine Monash University Melbourne Victoria Australia; 3. Faculty of Informatics and Data Science University of Regensburg Regensburg Germany
Sample Size Reduction by Applying ML Based Causal Inference Methods
AuthorsAhrim Youn; Gang Han; Emma Gerard; Neeraj Poonia; Sergio Olmos; Bingzhi Zhang; Meehyung Cho; Andres Houseman
Affiliations1. Evidence Generation and Decision Science, Sanofi Morristown New Jersey USA; 2. Evidence Generation and Decision Science, Sanofi Gentilly France; 3. Evidence Generation and Decision Science, Sanofi Hyderabad India; 4. Evidence Generation and Decision Science, Sanofi Barcelona Spain; 5. Biostatistics and Modeling, Argenx Boston Massachusetts USA
The Impact of Model Misspecification on the Individual Causal Association in Surrogate Endpoint Evaluation
AuthorsGokce Deliorman; Florian Stijven; Wim Van der Elst; Maria del Carmen Pardo; Ariel Alonso
Affiliations1. Department of Statistics and O.R Complutense University of Madrid Madrid Spain; 2. L‐BioStat, KU Leuven Leuven Belgium; 3. Janssen Pharmaceutica, Companies of Johnson & Johnson Beerse Belgium; 4. Interdisciplinary Mathematics Institute (IMI), Complutense University of Madrid Madrid Spain
A Bayesian Optimal Interval Design Considering Efficacy and Toxicity in Early Phase Basket Trials
AuthorsTomoyuki Kakizume; Kentaro Takeda; Masataka Taguri; Satoshi Morita
Affiliations1. Japan Biostatistics & Data Management Department, Daiichi Sankyo Co. Ltd Tokyo Japan; 2. Quantitative Sciences and Evidence Generation, Astellas Pharma Global Development, Inc Northbrook Illinois USA; 3. Department or Health Science Tokyo Medical University Tokyo Japan; 4. Department of Biomedical Statistics and Bioinformatics Kyoto University Graduate School of Medicine Kyoto Japan
Impact of Information Leakage in Platform Trials With Survival Endpoints on Type I Error Control
AuthorsQuynh Nguyen; Martin Posch; Benjamin Hofner; Franz König
Affiliations1. Section Data Science and Methods Paul‐Ehrlich‐Institut Langen Germany; 2. Department of Medical Informatics Biometry, and Epidemiology, Friedrich‐Alexander‐Universität Erlangen‐Nürnberg Erlangen Germany; 3. Institute of Medical Statistics, Center for Medical Data Science Medical University of Vienna Austria
Harmonic Fowlkes‐Mallows Index for Medical Diagnostics Tests and Optimal Cut‐Off Point Selection of Binary Diseases
AuthorsParthkumar Rabari; Purbasha Biswas; Jing X. Kersey; Hani Samawi
Affiliations1. Department of Biostatistics, Epidemiology, and Environmental Health Sciences Jiann‐Ping Hsu College of Public Health, Georgia Southern University Statesboro Georgia USA
Early Phase Dose‐Finding Designs for CAR ‐T Cell Therapies
AuthorsWeishi Chen; Pavel Mozgunov; Jimmy Mullaert; Xavier Paoletti
Affiliations1. MRC Biostatistics Unit University of Cambridge Cambridge UK; 2. Clinical Research Division Institut Curie Paris France; 3. University of Versaille St Quentin/Paris Saclay Paris France; 4. STAMPM, INSERM U1331 Paris France
Optimizing Randomization Ratios in Clinical Trials With Survival Endpoints
AuthorsLuoying Yang; Weijia Mai; Yuanyuan Han
Affiliations1. Bristol Myers Squibb Princeton New Jersey USA; 2. Department of Biostatistics Duke University Durham North Carolina USA
CUI ‐ MET : A Clinical Utility Index Based Analysis and Decision Framework for Dose Optimization in Multiple‐Dose, Multiple‐Outcome Randomized Trials
AuthorsFanni Zhang; Kristine Broglio; Michael Sweeting; Gina D'Angelo
Affiliations1. Oncology Biometrics, AstraZeneca Gaithersburg Maryland USA; 2. Oncology Biometrics, AstraZeneca London UK
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