发布求助
文献互助 智能选刊 最新文献

Statistics in Biopharmaceutical Research最新文献

筛选
英文 中文
A Basket Trial Design Based on Power Priors 基于功率先验的篮式试验设计
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-09-10 DOI: 10.1080/19466315.2024.2402275
Lukas Baumann, Lukas D. Sauer, Meinhard Kieser
{"title":"A Basket Trial Design Based on Power Priors","authors":"Lukas Baumann, Lukas D. Sauer, Meinhard Kieser","doi":"10.1080/19466315.2024.2402275","DOIUrl":"https://doi.org/10.1080/19466315.2024.2402275","url":null,"abstract":"In basket trials a treatment is investigated in several subgroups. They are primarily used in oncology in early clinical phases as single-arm trials with a binary endpoint. For their analysis prima...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"31 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142257863","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Remembering Gregory Campbell (1949-2023): An Accomplished Leader, Mentor, and Biostatistical Innovator 缅怀格雷戈里-坎贝尔（1949-2023）：一位杰出的领导者、导师和生物统计创新者
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-08-22 DOI: 10.1080/19466315.2024.2395196
Gene Pennello, Freda Cooner, Telba Irony, Karen Bandeen-Roche, Shanti Gomatam, Thomas Gwise, Larry Kessler, Richard Kotz, Thomas Louis, Kristen Meier, Norberto Pantoja-Galicia, Nicholas Petrick, Estelle Russek-Cohen, Laura Thompson, Jingjing Ye, Lilly Yue
{"title":"Remembering Gregory Campbell (1949-2023): An Accomplished Leader, Mentor, and Biostatistical Innovator","authors":"Gene Pennello, Freda Cooner, Telba Irony, Karen Bandeen-Roche, Shanti Gomatam, Thomas Gwise, Larry Kessler, Richard Kotz, Thomas Louis, Kristen Meier, Norberto Pantoja-Galicia, Nicholas Petrick, Estelle Russek-Cohen, Laura Thompson, Jingjing Ye, Lilly Yue","doi":"10.1080/19466315.2024.2395196","DOIUrl":"https://doi.org/10.1080/19466315.2024.2395196","url":null,"abstract":"Published in Statistics in Biopharmaceutical Research (Just accepted, 2024)","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"271 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142214769","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Combining Recurrent and Terminal Events Into a Composite Endpoint May Be Problematic 将经常性事件和终结性事件合并为一个综合终点可能存在问题
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-08-21 DOI: 10.1080/19466315.2024.2395404
Xiaofei Liu, Norbert Benda, Clemens Mittmann, Armin Koch
{"title":"Combining Recurrent and Terminal Events Into a Composite Endpoint May Be Problematic","authors":"Xiaofei Liu, Norbert Benda, Clemens Mittmann, Armin Koch","doi":"10.1080/19466315.2024.2395404","DOIUrl":"https://doi.org/10.1080/19466315.2024.2395404","url":null,"abstract":"In clinical trials for chronic heart failure (CHF), time to a composite of first hospitalization for worsening heart failure or death is a widely accepted primary efficacy measure. Motivated by low...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"18 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142214768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Simultaneous Confidence Intervals for Signal Detection and Ascertaining Precision of Adverse Event Rates in Clinical Trials 临床试验中信号检测和确定不良事件发生率精度的同步置信区间
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-08-05 DOI: 10.1080/19466315.2024.2388523
Guoqing Diao, Margaret Gamalo, Ram Tiwari
{"title":"Simultaneous Confidence Intervals for Signal Detection and Ascertaining Precision of Adverse Event Rates in Clinical Trials","authors":"Guoqing Diao, Margaret Gamalo, Ram Tiwari","doi":"10.1080/19466315.2024.2388523","DOIUrl":"https://doi.org/10.1080/19466315.2024.2388523","url":null,"abstract":"The marketing authorization of a medicinal product is contingent upon demonstration of safety and efficacy in support of the product’s labeled conditions of use. To demonstrate safety, one group of...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"15 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141941182","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Bayesian shrinkage estimation of credible subgroups for count data with excess zeros 对有多余零的计数数据的可信子群进行贝叶斯收缩估计
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-08-05 DOI: 10.1080/19466315.2024.2388520
Duy Ngo, Daniel Quartey, Patrick M Schnell, Richard Baumgartner, Shahrul Mt-Isa, Dai Feng
{"title":"Bayesian shrinkage estimation of credible subgroups for count data with excess zeros","authors":"Duy Ngo, Daniel Quartey, Patrick M Schnell, Richard Baumgartner, Shahrul Mt-Isa, Dai Feng","doi":"10.1080/19466315.2024.2388520","DOIUrl":"https://doi.org/10.1080/19466315.2024.2388520","url":null,"abstract":"Heterogeneity of treatment effects due to heterogeneous patient characteristics often arises in clinical trials. Subgroup analysis and the analysis of interactions are the most common approaches fo...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"3 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141941313","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Statistics Post-Pandemic: Paving the Scientific Path to Treatments, Vaccines, and Diagnostics—Special Issue for the 2022 Regulatory-Industry Statistics Workshop 大流行后的统计：为治疗、疫苗和诊断铺平科学道路--2022 年监管机构-行业统计研讨会特刊
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-07-31 DOI: 10.1080/19466315.2024.2368367
Chia-Wen Ko, Hope B. Knuckles
{"title":"Statistics Post-Pandemic: Paving the Scientific Path to Treatments, Vaccines, and Diagnostics—Special Issue for the 2022 Regulatory-Industry Statistics Workshop","authors":"Chia-Wen Ko, Hope B. Knuckles","doi":"10.1080/19466315.2024.2368367","DOIUrl":"https://doi.org/10.1080/19466315.2024.2368367","url":null,"abstract":"Published in Statistics in Biopharmaceutical Research (Vol. 16, No. 3, 2024)","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"23 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141941183","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
MT-Keyboard: A Bayesian Model-assisted Interval Design to Account for Toxicity Grades and Types for Phase I Trials MT-Keyboard：贝叶斯模型辅助区间设计，用于考虑 I 期试验的毒性等级和类型
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-06-26 DOI: 10.1080/19466315.2024.2368802
Kai Chen, Li Wang, Ying Yuan
{"title":"MT-Keyboard: A Bayesian Model-assisted Interval Design to Account for Toxicity Grades and Types for Phase I Trials","authors":"Kai Chen, Li Wang, Ying Yuan","doi":"10.1080/19466315.2024.2368802","DOIUrl":"https://doi.org/10.1080/19466315.2024.2368802","url":null,"abstract":"Conventionally, dose finding trials are based on dose-limiting toxicity (DLT) that only captures the most severe toxicities, e.g., treatment related grade 3 or higher toxicity according to the NCI ...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"15 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141516509","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Possible data-generating models of longitudinal continuous outcomes and intercurrent events to investigate estimands 纵向连续结果和并发事件的可能数据生成模型，以调查估计值
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-06-26 DOI: 10.1080/19466315.2024.2369266
Marian Mitroiu, Steven Teerenstra, Katrien Oude Rengerink, Frank Pétavy, Kit CB Roes
{"title":"Possible data-generating models of longitudinal continuous outcomes and intercurrent events to investigate estimands","authors":"Marian Mitroiu, Steven Teerenstra, Katrien Oude Rengerink, Frank Pétavy, Kit CB Roes","doi":"10.1080/19466315.2024.2369266","DOIUrl":"https://doi.org/10.1080/19466315.2024.2369266","url":null,"abstract":"We aimed to explore data-generating models to jointly simulate outcomes and intercurrent events for randomised clinical trials to enable the investigation of estimands.We developed four possible da...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"96 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141507320","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A statistical method for protocol modifications with heterogeneous population variances 具有异质群体方差的协议修改统计方法
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-06-26 DOI: 10.1080/19466315.2024.2369267
Chieh Chiang, Yuh-Jenn Wu, Li-Hsueh Cheng, Ching-Ti Liu, Chin-Fu Hsiao
{"title":"A statistical method for protocol modifications with heterogeneous population variances","authors":"Chieh Chiang, Yuh-Jenn Wu, Li-Hsueh Cheng, Ching-Ti Liu, Chin-Fu Hsiao","doi":"10.1080/19466315.2024.2369267","DOIUrl":"https://doi.org/10.1080/19466315.2024.2369267","url":null,"abstract":"During the course of a clinical trial, the procedure may need to be modified based on medical or practical results. For example, in trials with low recruitment rates, the data monitoring committee ...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"145 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141613835","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Comb-BOIN12: A Utility-Based Bayesian Optimal Interval Design for Dose Optimization in Cancer Drug-Combination Trials Comb-BOIN12：基于效用的贝叶斯最佳区间设计，用于癌症联合用药试验中的剂量优化
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-06-26 DOI: 10.1080/19466315.2024.2370403
Mengyi Lu, Jingyi Zhang, Ying Yuan, Ruitao Lin
{"title":"Comb-BOIN12: A Utility-Based Bayesian Optimal Interval Design for Dose Optimization in Cancer Drug-Combination Trials","authors":"Mengyi Lu, Jingyi Zhang, Ying Yuan, Ruitao Lin","doi":"10.1080/19466315.2024.2370403","DOIUrl":"https://doi.org/10.1080/19466315.2024.2370403","url":null,"abstract":"Drug combinations are increasingly utilized in cancer treatment to enhance drug effectiveness through synergistic therapeutic effects. However, determining the optimal biological dose combination (...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"74 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141615027","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
下一页 尾页
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整，为了账户安全，请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
请完成安全验证×
相关产品
×
本文献相关产品
联系我们：info@booksci.cn Book学术提供免费学术资源搜索服务，方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号：481959085
Book学术官方微信