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检索条件"机构=Biostat and Programming"
418 条 记 录,以下是21-30 订阅
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Guest Editors' Note on the Special Issue Real-World Evidence
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JOURNAL OF BIOPHARMACEUTICAL STATISTICS 2022年 第1期32卷 1-3页
作者: Lin, Junjing Li, Qian Takeda Pharmaceut Stat & Quantitat Sci Cambridge MA 02139 USA Stat & Data Corp Dept Biostat & Programming Tempe AZ USA
来源: 评论
Statistical Evaluation of Four Central Reading Processes
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STATISTICS IN BIOPHARMACEUTICAL RESEARCH 2021年 第1期13卷 82-90页
作者: Fan, Chunpeng Wei, Lynn Sanofi US Inc Dept Biostat & Programming Bridgewater NJ 08807 USA
In medical and clinical studies, videos, images, or other form of information carriers may be centrally read to provide scores or measurements for medically or clinically meaningful endpoints. Since the simple one cen... 详细信息
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Increased risk of urinary tract infection and pyelonephritis under concomitant use of sodium-dependent glucose cotransporter 2 inhibitors with antidiabetic, antidyslipidemic, and antihypertensive drugs: An observational study
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FUNDAMENTAL & CLINICAL PHARMACOLOGY 2022年 第6期36卷 1106-1114页
作者: Tada, Keisuke Gosho, Masahiko Sanofi KK Biostat & Programming Tokyo Opera City Tower Tokyo Japan Univ Tsukuba Grad Sch Comprehens Human Sci Ibaraki Japan Univ Tsukuba Fac Med Dept Biostat Ibaraki Japan
Urinary tract infection (UTI) and pyelonephritis cause urosepsis, which can become life threating. Sodium-dependent glucose cotransporter 2 (SGLT2) inhibitors, a class of oral anti-diabetic drugs, may increase the ris... 详细信息
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Some Multiplicity Adjustment Procedures for Clinical Trials with Sequential Design and Multiple Endpoints
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STATISTICS IN BIOPHARMACEUTICAL RESEARCH 2024年 第1期16卷 104-115页
作者: Luo, Xiaodong Quan, Hui Sanofi US Biostat & Programming 55 Corp Dr Bridgewater NJ 08807 USA
This article proposes some new multiplicity adjustment procedures for clinical trials with multiple endpoints and multiple interim analyses. The proposed sequential procedures, adapting the popular multiple comparison... 详细信息
来源: 评论
Bayesian dose regimen assessment in early phase oncology incorporating pharmacokinetics and pharmacodynamics
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BIOMETRICS 2022年 第1期78卷 300-312页
作者: Gerard, Emma Zohar, Sarah Hoai-Thu Thai Lorenzato, Christelle Riviere, Marie-Karelle Ursino, Moreno Univ Paris Sorbonne Univ Ctr Rech Cordeliers INSERM F-75006 Paris France Sanoli R&D Oncol Biostat Biostat & Programming Dept Vitry Sur Seine France Sanofi R&D Biostat & Programming Dept Stat Methodol Grp Chilly Mazarin France Sanofi R&D Translat Dis Modeling Digital & Data Sci Chilly Mazarin France Univ Paris AP HP F CRIN Partners Platform Paris France
Phase I dose-finding trials in oncology seek to find the maximum tolerated dose of a drug under a specific schedule. Evaluating drug schedules aims at improving treatment safety while maintaining efficacy. However, wh... 详细信息
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Evaluating Treatment Efficacy by Combining Multiple Measures in Clinical Trial Applications
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PHARMACEUTICAL MEDICINE 2023年 第1期37卷 7-16页
作者: Al Masud, Abdullah Weerahandi, Samaradasa Yu, Ching-Ray Sanofi US Biostat & Programming 55 Corp Dr Bridgewater NJ 08807 USA X Tech LLC Edison NJ USA Pfizer Inc New York NY USA
A variety of clinical and laboratory measures can be used in clinical trials to assess the benefit of a new treatment over the standard of care. Data from clinical studies are often analyzed by combining individual ou...
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A confirmatory basket design considering non-inferiority and superiority testing
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JOURNAL OF BIOPHARMACEUTICAL STATISTICS 2024年 第2期34卷 205-221页
作者: Zhang, Yaohua Chu, Chenghao Beckman, Robert A. Gao, Lei Laird, Glen Yi, Bingming Vertex Pharmaceut Inc Dept Biometr Boston MA 02210 USA Georgetown Univ Lombardi Comprehens Canc Ctr Dept Oncol Med Ctr Washington DC USA Georgetown Univ Lombardi Comprehens Canc Ctr Dept Biostat Bioinformat & Biomath Med Ctr Washington DC USA Georgetown Univ Innovat Ctr Biomed Informat Med Ctr Washington DC USA Moderna Dept Biostat & Programming Cambridge MA USA
For multiple rare diseases as defined by a common biomarker signature, or a disease with multiple disease subtypes of low frequency, it is often possible to provide confirmatory evidence for these disease or subtypes ... 详细信息
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Estimating the treatment effect for adherers using multiple imputation
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PHARMACEUTICAL STATISTICS 2022年 第3期21卷 525-534页
作者: Luo, Junxiang Ruberg, Stephen J. Qu, Yongming Moderna Inc Dept Biostat & Programming Cambridge MA USA Analytix Thinking LCC Indianapolis IN USA Eli Lilly & Co Dept Stat Data & Analyt Indianapolis IN 46285 USA
Randomized controlled trials are considered the gold standard to evaluate the treatment effect (estimand) for efficacy and safety. According to the recent International Council on Harmonization (ICH)-E9 addendum (R1),... 详细信息
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Information fraction estimation: Strategies for a phase 3 non-inferiority maximum duration design with time to event outcome
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PHARMACEUTICAL STATISTICS 2023年 第6期22卷 1031-1045页
作者: Dang, Ha M. Krailo, Mark D. Alonzo, Todd A. Mack, Wendy J. Kairalla, John A. Univ Southern Calif Dept Populat & Publ Hlth Sci Los Angeles CA USA Childrens Oncol Grp Monrovia CA USA Johnson & Johnson Med Devices Co Biostat Programming & Data Management 29B Technol Dr Irvine CA 92618 USA Univ Florida Coll Med Dept Biostat Gainesville FL USA Univ Florida Coll Publ Hlth & Hlth Profess Dept Biostat Gainesville FL USA
There is considerable debate surrounding the choice of methods to estimate information fraction for futility monitoring in a randomized non-inferiority maximum duration trial. This question was motivated by a pediatri... 详细信息
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A simulation-free group sequential design with max-combo tests in the presence of non-proportional hazards
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PHARMACEUTICAL STATISTICS 2021年 第4期20卷 879-897页
作者: Wang, Lili Luo, Xiaodong Zheng, Cheng Univ Michigan Dept Biostat Ann Arbor MI 48109 USA Sanofi US Dept Biostat & Programming Res & Dev Bridgewater NJ 08807 USA
Non-proportional hazards (NPH) have been observed in many immuno-oncology clinical trials. Weighted log-rank tests (WLRT) with suitable weights can be used to improve the power of detecting the difference between surv... 详细信息
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