Pub Date : 2024-09-10DOI: 10.1080/19466315.2024.2402275
Lukas Baumann, Lukas D. Sauer, Meinhard Kieser
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...
{"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":null,"pages":null},"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}
Pub Date : 2024-08-22DOI: 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
Published in Statistics in Biopharmaceutical Research (Just accepted, 2024)
发表于《生物制药研究统计》（刚刚接受，2024 年）
{"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":null,"pages":null},"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}
Pub Date : 2024-08-21DOI: 10.1080/19466315.2024.2395404
Xiaofei Liu, Norbert Benda, Clemens Mittmann, Armin Koch
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...
{"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":null,"pages":null},"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}
Pub Date : 2024-08-05DOI: 10.1080/19466315.2024.2388523
Guoqing Diao, Margaret Gamalo, Ram Tiwari
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...
药品的上市许可取决于其安全性和有效性是否符合产品标注的使用条件。为了证明安全性，一组...
{"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":null,"pages":null},"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}
Pub Date : 2024-08-05DOI: 10.1080/19466315.2024.2388520
Duy Ngo, Daniel Quartey, Patrick M Schnell, Richard Baumgartner, Shahrul Mt-Isa, Dai Feng
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...
{"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":null,"pages":null},"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}
Pub Date : 2024-07-31DOI: 10.1080/19466315.2024.2368367
Chia-Wen Ko, Hope B. Knuckles
Published in Statistics in Biopharmaceutical Research (Vol. 16, No. 3, 2024)
发表于《生物制药研究统计》（第 16 卷第 3 期，2024 年）
{"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":null,"pages":null},"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}
Pub Date : 2024-06-26DOI: 10.1080/19466315.2024.2368802
Kai Chen, Li Wang, Ying Yuan
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 ...
{"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":null,"pages":null},"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}
Pub Date : 2024-06-26DOI: 10.1080/19466315.2024.2369266
Marian Mitroiu, Steven Teerenstra, Katrien Oude Rengerink, Frank Pétavy, Kit CB Roes
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...
我们的目标是探索数据生成模型，以联合模拟随机临床试验的结果和并发症，从而对估算值进行调查。
{"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":null,"pages":null},"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}
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 ...
{"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":null,"pages":null},"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}
Pub Date : 2024-06-26DOI: 10.1080/19466315.2024.2370403
Mengyi Lu, Jingyi Zhang, Ying Yuan, Ruitao Lin
Drug combinations are increasingly utilized in cancer treatment to enhance drug effectiveness through synergistic therapeutic effects. However, determining the optimal biological dose combination (...
癌症治疗中越来越多地使用联合用药，通过协同治疗效果提高药物疗效。然而，确定最佳生物剂量组合（...
{"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":null,"pages":null},"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}
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