Paper Review Records
All Paper Review Records
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Review days = acceptance date − received date. PDF, DOI, and publisher-page sources are retained.
Challenges of Modeling Biomarker Effects on Time-to-Event Outcomes
AuthorsTuo Wang; Yongming Qu
Affiliations1. Department of Global Statistical Sciences and Advanced Analytics, Eli Lilly and Company
Statistical Methodology Groups in the Pharmaceutical Industry #
AuthorsJenny Devenport; Tobias Mielke; Mouna Akacha; Kaspar Rufibach; Alex Ocampo; Vivian Lanius; Marc Vandemeulebroecke; Philip Hougaard; Pierre Collin; David Wright; Jurgen Hummel; Cornelia Ursula Kunz; Mike Krams
Affiliations1. Hoffmann-La Roche AG; 2. Johnson and Johnson; 3. Novartis AG; 4. Merck KGaA; 5. UCB Biosciences GmbH; 6. Bayer BCC AG; 7. H. Lundbeck A/S; 8. Bristol Myers Squibb; 9. AstraZeneca UK Limited; 10. Cytel; 11. Boehringer Ingelheim International GmbH; 12. Berry Consultants
“6 Choose 4”: A Framework to Understand and Facilitate Discussion of Strategies for Overall Survival Safety Monitoring
AuthorsGodwin Yung; Kaspar Rufibach; Marcel Wolbers; Mark Yan; Jue Wang
Affiliations1. F. Hoffmann-La Roche AG
An Adaptive Biomarker-Based Umbrella Trial Design Using Bayesian Latent Class Model
AuthorsJiaying Guo; Mengyi Lu; Yan Han; Leng Han; Yong Zang
Affiliations1. Department of Biostatistics and Health Data Sciences, School of Medicine, Indiana University; 2. Eli Lilly and Company; 3. Department of Biostatistics, Nanjing Medical University; 4. Center for Computational Biology and Bioinformatics, School of Medicine, Indiana University
A Bayesian Adaptive Marker-Stratified Design for Phase II Clinical Trials Using Calibrated Spike-and-Slab Priors
AuthorsMu Shan; Mengyi Lu; Leng Han; Yan Han; Yong Zang
Affiliations1. Department of Biostatistics and Health Data Sciences, School of Medicine, Indiana University; 2. Eli Lilly and Company; 3. Department of Biostatistics, School of Public Health, Nanjing Medical University; 4. Center for Computational Biology and Bioinformatics, School of Medicine, Indiana University
Statistical Method for Threshold Value Determination of Diagnostic Biomarker in Noisy Data
AuthorsYichen Jia; Donghui Zhang; Francois Beckers; Scott Gallichan; Elizabeth J. Kelly; Saranya Sridhar
Affiliations1. Global Biostatistical Science, Sanofi Pasteur; 2. Global Immunology, Sanofi Pasteur; 3. Global Clinical Development, Sanofi Pasteur
Considerations on Interim Evaluation of OS in Pivotal Oncology Trials
AuthorsWeidong Zhang; Sunhee Ro; Jing Zhao; Xiaoyun Li; Qi Jiang; Linda Sun; Olga Marchenko; Chengxing (Cindy) Lu; Rong Liu; on behalf of the Interim Evaluation of OS Workstream of the Statistical Methods in Oncology Scientific Working Group, Biopharmaceutical Section, American Statistical Association
Affiliations1. Sana Biotechnology; 2. Nurix Therapeutics; 3. Merck & Co; 4. BeOne Medicines; 5. Pfizer Inc; 6. Bayer; 7. AstraZeneca Plc; 8. Regeneron Pharmaceuticals Inc
Minimizing Harm: Optimal Monitoring Boundaries When Harm is Present
AuthorsJonathon Vallejo; Shu Wang
Affiliations1. Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration
A Bayesian Latent Subgroup Design for Basket Trials with Survival Endpoints
AuthorsYueyang Han; Haolun Shi
Affiliations1. Department of Statistics and Actuarial Science, Simon Fraser University
Novel Statistical Designs and Considerations to Support Diversity and Inclusion in Clinical Trials
AuthorsFeng Tian; Meizi Liu; Yunqi Zhao; Jianchang Lin; Rachael Liu
Affiliations1. University of Texas MD Anderson Cancer Center; 2. Takeda Pharmaceuticals
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