Pub Date : 2024-03-05DOI: 10.1080/19466315.2024.2327291
Kaspar Rufibach, Marcel Wolbers, Jenny Devenport, Godwin Yung, Chris Harbron, Alun Bedding, Zhiyue Huang, Ray Lin, Herbert Pang, Daniel SabanésBové, Jianmei Wang
Innovation, defined as the successful implementation at scale of a new invention, is key for continued success of the drug development enterprise. In this paper we focus on statistical innovation i...
{"title":"Implementation of statistical innovation in a pharmaceutical company","authors":"Kaspar Rufibach, Marcel Wolbers, Jenny Devenport, Godwin Yung, Chris Harbron, Alun Bedding, Zhiyue Huang, Ray Lin, Herbert Pang, Daniel SabanésBové, Jianmei Wang","doi":"10.1080/19466315.2024.2327291","DOIUrl":"https://doi.org/10.1080/19466315.2024.2327291","url":null,"abstract":"Innovation, defined as the successful implementation at scale of a new invention, is key for continued success of the drug development enterprise. In this paper we focus on statistical innovation i...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"35 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140034187","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 : 2024-02-06DOI: 10.1080/19466315.2024.2308882
Mitchell Aaron Schepps, Weng Kee Wong, Matt Austin, Volodymyr Anisimov
A common problem seen in the ineffective execution of global multicenter trials is the frequent inability to recruit a sufficient number of patients. A myriad of barriers to recruiting enough patie...
{"title":"Optimizing Patient Recruitment in Global Clinical Trials using Nature-Inspired Metaheuristics","authors":"Mitchell Aaron Schepps, Weng Kee Wong, Matt Austin, Volodymyr Anisimov","doi":"10.1080/19466315.2024.2308882","DOIUrl":"https://doi.org/10.1080/19466315.2024.2308882","url":null,"abstract":"A common problem seen in the ineffective execution of global multicenter trials is the frequent inability to recruit a sufficient number of patients. A myriad of barriers to recruiting enough patie...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"77 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139763262","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 : 2024-02-05DOI: 10.1080/19466315.2024.2313986
Cornelia Ursula Kunz, Sergey Tarima, Gary L. Rosner, Richard Emsley, Madeline Bauer, Christopher Jennison, James L. Rosenberger, Nigel Stallard, Sarah Zohar, Nancy Flournoy
The COVID-19 pandemic impacted clinical trials in ways never expected. However, similar challenges should now be expected going forward. These challenges made us aware of statistical problems arisi...
{"title":"Bayesian and Frequentist Approaches to Rescuing Disrupted Trials: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions","authors":"Cornelia Ursula Kunz, Sergey Tarima, Gary L. Rosner, Richard Emsley, Madeline Bauer, Christopher Jennison, James L. Rosenberger, Nigel Stallard, Sarah Zohar, Nancy Flournoy","doi":"10.1080/19466315.2024.2313986","DOIUrl":"https://doi.org/10.1080/19466315.2024.2313986","url":null,"abstract":"The COVID-19 pandemic impacted clinical trials in ways never expected. However, similar challenges should now be expected going forward. These challenges made us aware of statistical problems arisi...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"87 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139763362","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 : 2024-02-01DOI: 10.1080/19466315.2024.2305574
Published in Statistics in Biopharmaceutical Research (Vol. 16, No. 1, 2024)
发表于《生物制药研究统计》（第 16 卷第 1 期，2024 年）
{"title":"Statistics in Biopharmaceutical Research 2023 Associate Editors","authors":"","doi":"10.1080/19466315.2024.2305574","DOIUrl":"https://doi.org/10.1080/19466315.2024.2305574","url":null,"abstract":"Published in Statistics in Biopharmaceutical Research (Vol. 16, No. 1, 2024)","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"21 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139662384","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 : 2024-01-23DOI: 10.1080/19466315.2024.2308877
Li Yang, Guoqing Diao, William F. Rosenberger
In the precision medicine paradigm, it is of interest to identify subgroups that benefit most from the treatment. However, the subgroup often cannot be identified until after a large-scale clinical...
{"title":"A Two-Stage Covariate-Adjusted Response-Adaptive Enrichment Design","authors":"Li Yang, Guoqing Diao, William F. Rosenberger","doi":"10.1080/19466315.2024.2308877","DOIUrl":"https://doi.org/10.1080/19466315.2024.2308877","url":null,"abstract":"In the precision medicine paradigm, it is of interest to identify subgroups that benefit most from the treatment. However, the subgroup often cannot be identified until after a large-scale clinical...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"41 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139578736","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 : 2024-01-23DOI: 10.1080/19466315.2024.2308856
David Dejardin, Bo Huang, Ying Yuan, Ulrich Beyer, Jane Fridlyand, Jiawen Zhu
Over the past decade, drug development in oncology has shifted from cytotoxic agents to drugs with new mechanisms of action, such as cancer immunotherapies, targeted therapeutics, T-cell engagers a...
{"title":"Dose Optimization for Novel Oncology Agents: Design Options and Strategies","authors":"David Dejardin, Bo Huang, Ying Yuan, Ulrich Beyer, Jane Fridlyand, Jiawen Zhu","doi":"10.1080/19466315.2024.2308856","DOIUrl":"https://doi.org/10.1080/19466315.2024.2308856","url":null,"abstract":"Over the past decade, drug development in oncology has shifted from cytotoxic agents to drugs with new mechanisms of action, such as cancer immunotherapies, targeted therapeutics, T-cell engagers a...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"7 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139590480","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 : 2024-01-05DOI: 10.1080/19466315.2023.2289514
Bharati Kumar, Jonathan W. Bartlett
Nonproportional hazards (NPH) have been observed in confirmatory clinical trials with time to event outcomes. Under NPH, the hazard ratio does not stay constant over time and the log rank test is n...
{"title":"Weighted Hazard Ratio Estimation for Delayed and Diminishing Treatment Effect","authors":"Bharati Kumar, Jonathan W. Bartlett","doi":"10.1080/19466315.2023.2289514","DOIUrl":"https://doi.org/10.1080/19466315.2023.2289514","url":null,"abstract":"Nonproportional hazards (NPH) have been observed in confirmatory clinical trials with time to event outcomes. Under NPH, the hazard ratio does not stay constant over time and the log rank test is n...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"38 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139103532","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 : 2024-01-02DOI: 10.1080/19466315.2023.2298961
Lindsay R Berry, Elizabeth Lorenzi, Nicholas S Berry, Amy M Crawford, Peter Jacko, Kert Viele
Many trial designs, such as dose-finding trials, shared-control designs, or adaptive platform trials, investigate multiple therapies simultaneously. Often these trials seek to identify the best arm...
{"title":"Effects of Allocation Method and Time Trends on Identification of the Best Arm in Multi-arm Trials","authors":"Lindsay R Berry, Elizabeth Lorenzi, Nicholas S Berry, Amy M Crawford, Peter Jacko, Kert Viele","doi":"10.1080/19466315.2023.2298961","DOIUrl":"https://doi.org/10.1080/19466315.2023.2298961","url":null,"abstract":"Many trial designs, such as dose-finding trials, shared-control designs, or adaptive platform trials, investigate multiple therapies simultaneously. Often these trials seek to identify the best arm...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"34 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139083546","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 : 2023-12-18DOI: 10.1080/19466315.2023.2296648
Francois Mercier, Victoria Homer, Junxian Geng, Hontao Zhang, Stefan Englert, Natalia Kan-Dobrosky, Anja Victor
The R1 addendum to ICH E9 (E9-R1) provides guidance on the definition of estimands in clinical drug development. While the E9-R1 has seen uptake in randomized late-stage clinical trials, its implem...
ICH E9 的 R1 增补（E9-R1）为临床药物开发中估算指标的定义提供了指导。虽然 E9-R1 已在后期随机临床试验中得到采纳，但其执行情况仍不容乐观。
{"title":"Estimands in oncology early clinical development: Assessing the impact of intercurrent events on the dose-toxicity relationship","authors":"Francois Mercier, Victoria Homer, Junxian Geng, Hontao Zhang, Stefan Englert, Natalia Kan-Dobrosky, Anja Victor","doi":"10.1080/19466315.2023.2296648","DOIUrl":"https://doi.org/10.1080/19466315.2023.2296648","url":null,"abstract":"The R1 addendum to ICH E9 (E9-R1) provides guidance on the definition of estimands in clinical drug development. While the E9-R1 has seen uptake in randomized late-stage clinical trials, its implem...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"307 3 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2023-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138821316","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 : 2023-12-12DOI: 10.1080/19466315.2023.2292774
Jiawei Wei, Jiajun Xu, Björn Bornkamp, Ray Lin, Hong Tian, Dong Xi, Xin Zhang, Ziqiang Zhao, Satrajit Roychoudhury
ICH E9(R1) specifies the importance of precisely defining the treatment effect for clinical trials – to inform patient choices and facilitate evidence-based decision-making. FDA's guidance on covar...
ICH E9(R1)明确规定了精确定义临床试验治疗效果的重要性--为患者的选择提供信息并促进循证决策。美国食品和药物管理局（FDA）关于临床试验疗效一致性的指导意见...
{"title":"Conditional and Unconditional treatment effects in randomized clinical trials: Estimands, Estimation, and Interpretation","authors":"Jiawei Wei, Jiajun Xu, Björn Bornkamp, Ray Lin, Hong Tian, Dong Xi, Xin Zhang, Ziqiang Zhao, Satrajit Roychoudhury","doi":"10.1080/19466315.2023.2292774","DOIUrl":"https://doi.org/10.1080/19466315.2023.2292774","url":null,"abstract":"ICH E9(R1) specifies the importance of precisely defining the treatment effect for clinical trials – to inform patient choices and facilitate evidence-based decision-making. FDA's guidance on covar...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"33 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2023-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138686311","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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