Zhiwei Zhang, Carrie Nielson, Ching‐Yi Chuo & Zhishen Ye. (2024)
Information‐based
group sequential design for
post‐market
safety monitoring of medical products using real world data
. Pharmaceutical Statistics.
Crossref
Nick R. Parsons, Joydeep Basu & Nigel Stallard. (2024) Group sequential designs for pragmatic clinical trials with early outcomes: methods and guidance for planning and implementation. BMC Medical Research Methodology 24:1.
Crossref
Ruyi Liu, Fan Li, Denise Esserman & Mary M. Ryan. (2023) Group sequential two‐stage preference designs. Statistics in Medicine 43:2, pages 315-341.
Crossref
Michael A Proschan, Martha Nason, Ana M Ortega-Villa & Jing Wang. (2024) Changing interim monitoring in response to internal clinical trial data. Biometrics 80:1.
Crossref
Nigel Stallard. (2022) Adaptive enrichment designs with a continuous biomarker. Biometrics 79:1, pages 9-19.
Crossref
Josephine N. Khan, Peter K. Kimani, Ekkehard Glimm & Nigel Stallard. (2022) Adjusting for treatment selection in phase II/III clinical trials with time to event data. Statistics in Medicine 42:2, pages 146-163.
Crossref
Kim May Lee, David S. RobertsonThomas JakiRichard Emsley. (2022) The benefits of covariate adjustment for adaptive multi-arm designs. Statistical Methods in Medical Research 31:11, pages 2104-2121.
Crossref
Bryan S. Nelson, Lingyun Liu & Cyrus Mehta. (2021)
A
simulation‐based
comparison of estimation methods for adaptive and classical group sequential clinical trials
. Pharmaceutical Statistics 21:3, pages 599-611.
Crossref
Lisa V. Hampson, Björn Bornkamp, Björn Holzhauer, Joseph Kahn, Markus R. Lange, Wen‐Lin Luo, Giovanni Della Cioppa, Kelvin Stott & Steffen Ballerstedt. (2021) Improving the assessment of the probability of success in late stage drug development. Pharmaceutical Statistics 21:2, pages 439-459.
Crossref
Kenichi Takahashi, Ryota Ishii, Kazushi Maruo & Masahiko Gosho. (2022) Statistical methods for seamless phase II/III designシームレス第II/III相デザインの統計手法. Japanese Journal of Biometrics 43:1, pages 37-62.
Crossref
David Benkeser, Iván Díaz, Alex Luedtke, Jodi Segal, Daniel Scharfstein & Michael Rosenblum. (2020) Improving precision and power in randomized trials for COVID‐19 treatments using covariate adjustment, for binary, ordinal, and time‐to‐event outcomes. Biometrics 77:4, pages 1467-1481.
Crossref
Qingyan Tong, Chi-Yang Chu, Dong Zhou & Yulei Feng. (2021) Does Internet Connectedness Disconnect Marriage? A Micro Empirical Analysis. Social Indicators Research 158:1, pages 143-176.
Crossref
Michael J. Grayling & Adrian P. Mander. (2021) Accounting for variation in the required sample size in the design of group-sequential trials. Contemporary Clinical Trials 107, pages 106459.
Crossref
Donald A. Berry, Scott Berry, Peter Hale, Leah Isakov, Andrew W. Lo, Kien Wei Siah & Chi Heem Wong. (2020) A cost/benefit analysis of clinical trial designs for COVID-19 vaccine candidates. PLOS ONE 15:12, pages e0244418.
Crossref
Nigel Stallard, Susan Todd, Elizabeth G. Ryan & Simon Gates. (2020) Comparison of Bayesian and frequentist group-sequential clinical trial designs. BMC Medical Research Methodology 20:1.
Crossref
Junxiao Hu, Patrick J. Blatchford, Neil A. Goldenberg & John M. Kittelson. (2020) Group sequential designs for clinical trials with bivariate endpoints. Statistics in Medicine 39:26, pages 3823-3839.
Crossref
Peter K. Kimani, Susan Todd, Lindsay A. Renfro, Ekkehard Glimm, Josephine N. Khan, John A. Kairalla & Nigel Stallard. (2020) Point and interval estimation in two‐stage adaptive designs with time to event data and biomarker‐driven subpopulation selection. Statistics in Medicine 39:19, pages 2568-2586.
Crossref
Pranab Ghosh, Lingyun Liu & Cyrus Mehta. (2020) Adaptive multiarm multistage clinical trials. Statistics in Medicine 39:8, pages 1084-1102.
Crossref
C. Baayen, C. Volteau, C. Flamant & P. Blanche. (2019) Sequential trials in the context of competing risks: Concepts and case study, with R and SAS code. Statistics in Medicine 38:19, pages 3682-3702.
Crossref
Tobias Mütze, Ekkehard Glimm, Heinz Schmidli & Tim Friede. (2018) Group sequential designs with robust semiparametric recurrent event models. Statistical Methods in Medical Research 28:8, pages 2385-2403.
Crossref
Tobias Mütze, Ekkehard Glimm, Heinz Schmidli & Tim Friede. (2018) Group sequential designs for negative binomial outcomes. Statistical Methods in Medical Research 28:8, pages 2326-2347.
Crossref
Haolun Shi & Guosheng Yin. (2019) Control of Type I Error Rates in Bayesian Sequential Designs. Bayesian Analysis 14:2.
Crossref
Dong Zhou & Langchuan Peng. (2017) The Relationship Between the Gender Gap in Subjective Well-Being and Leisure Activities in China. Journal of Happiness Studies 19:7, pages 2139-2166.
Crossref
Neal O. Jeffries, James F. Troendle & Nancy L. Geller. (2018) Detecting Treatment Differences in Group Sequential Longitudinal Studies with Covariate Adjustment. Biometrics 74:3, pages 1072-1081.
Crossref
David M. Reboussin & Dave L. DeMets. 2018. Biopharmaceutical Applied Statistics Symposium. Biopharmaceutical Applied Statistics Symposium
235
267
.
Pranab Ghosh, Lingyun Liu, P. Senchaudhuri, Ping Gao & Cyrus Mehta. (2017) Design and Monitoring of Multi-Arm Multi-Stage Clinical Trials. Biometrics 73:4, pages 1289-1299.
Crossref
Lisa V. HampsonRoland Fisch, Linh M. VanThomas Jaki. (2016) Asymmetric inner wedge group sequential tests with applications to verifying whether effective drug concentrations are similar in adults and children. Statistics in Medicine 36:3, pages 426-441.
Crossref
Jay Bartroff & Jinlin Song. (2015) A Rejection Principle for Sequential Tests of Multiple Hypotheses Controlling Familywise Error Rates. Scandinavian Journal of Statistics 43:1, pages 3-19.
Crossref
Gernot Wassmer & Werner BrannathGernot Wassmer & Werner Brannath. 2016. Group Sequential and Confirmatory Adaptive Designs in Clinical Trials. Group Sequential and Confirmatory Adaptive Designs in Clinical Trials
101
130
.
Nigel StallardCornelia Ursula KunzSusan ToddNicholas ParsonsTim Friede. (2015) Flexible selection of a single treatment incorporating short‐term endpoint information in a phase II/III clinical trial. Statistics in Medicine 34:23, pages 3104-3115.
Crossref
Jennifer C NelsonAndrea J CookOnchee YuShanshan ZhaoLisa A JacksonBruce M Psaty. (2011) Methods for observational post-licensure medical product safety surveillance. Statistical Methods in Medical Research 24:2, pages 177-193.
Crossref
Kelly G. StrattonAndrea J. CookLisa A. JacksonJennifer C. Nelson. (2014) Simulation study comparing exposure matching with regression adjustment in an observational safety setting with group sequential monitoring. Statistics in Medicine 34:7, pages 1117-1133.
Crossref
Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin & Christopher B. GrangerLawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin & Christopher B. Granger. 2015. Fundamentals of Clinical Trials. Fundamentals of Clinical Trials
373
401
.
Abigail B. ShobenScott S. Emerson. (2014) Violations of the independent increment assumption when using generalized estimating equation in longitudinal group sequential trials. Statistics in Medicine 33:29, pages 5041-5056.
Crossref
Jay Bartroff & Jinlin Song. (2014) Sequential tests of multiple hypotheses controlling type I and II familywise error rates. Journal of Statistical Planning and Inference 153, pages 100-114.
Crossref
Susan Todd. 2014. Wiley StatsRef: Statistics Reference Online. Wiley StatsRef: Statistics Reference Online.
David M. Reboussin. 2014. Wiley StatsRef: Statistics Reference Online. Wiley StatsRef: Statistics Reference Online.
Ming T. Tan. 2014. Wiley StatsRef: Statistics Reference Online. Wiley StatsRef: Statistics Reference Online.
Gernot Wassmer. 2014. Wiley StatsRef: Statistics Reference Online. Wiley StatsRef: Statistics Reference Online.
Gernot Wassmer. 2014. Methods and Applications of Statistics in Clinical Trials. Methods and Applications of Statistics in Clinical Trials
467
482
.
Ming T. Tan. 2014. Methods and Applications of Statistics in Clinical Trials. Methods and Applications of Statistics in Clinical Trials
102
110
.
Susan Todd. 2014. Methods and Applications of Statistics in Clinical Trials. Methods and Applications of Statistics in Clinical Trials
323
333
.
Isaac Wu Hong‐Dar. 2013. Statistical Models and Methods for Reliability and Survival Analysis. Statistical Models and Methods for Reliability and Survival Analysis
311
319
.
Dejian Lai. (2013) Sample size determination for group sequential test under fractional Brownian motion. Electronic Journal of Statistics 7:none.
Crossref
Eric S. Leifer & Nancy L. Geller. 2012. Design and Analysis of Experiments. Design and Analysis of Experiments
213
249
.
Guosheng Yin. 2011. Clinical Trial Design. Clinical Trial Design
311
327
.
Nigel Stallard. (2011) An adaptive seamless phase II/III clinical trial design incorporating short-term endpoint information. Trials 12:S1.
Crossref
Nigel StallardSusan Todd. (2010) Seamless phase II/III designs. Statistical Methods in Medical Research 20:6, pages 623-634.
Crossref
Patrick J. LoehrerSrSrYang FengHiginia CardenesLynne WagnerJoanna M. BrellDavid CellaPatrick FlynnRamesh K. RamanathanChristopher H. CraneSteven R. AlbertsAl B. BensonIIIIII. (2011) Gemcitabine Alone Versus Gemcitabine Plus Radiotherapy in Patients With Locally Advanced Pancreatic Cancer: An Eastern Cooperative Oncology Group Trial. Journal of Clinical Oncology 29:31, pages 4105-4112.
Crossref
T. Friede, N. Parsons, N. Stallard, S. Todd, E. Valdes Marquez, J. Chataway & R. Nicholas. (2011) Designing a seamless phase II/III clinical trial using early outcomes for treatment selection: An application in multiple sclerosis. Statistics in Medicine 30:13, pages 1528-1540.
Crossref
Madhu Mazumdar & Heejung Bang. 2011. Essential Statistical Methods for Medical Statistics. Essential Statistical Methods for Medical Statistics
269
290
.
Eunsik Park & Yuan‐chin I. Chang. (2010) Sequential Analysis of Longitudinal Data in a Prospective Nested Case–Control Study. Biometrics 66:4, pages 1034-1042.
Crossref
Nigel Stallard. (2010) A confirmatory seamless phase II/III clinical trial design incorporating short‐term endpoint information. Statistics in Medicine 29:9, pages 959-971.
Crossref
Fredrik Öhrn & Christopher Jennison. (2010) Optimal group‐sequential designs for simultaneous testing of superiority and non‐inferiority. Statistics in Medicine 29:7-8, pages 743-759.
Crossref
Nigel Stallard & Susan Todd. 2010. Pharmaceutical Sciences Encyclopedia. Pharmaceutical Sciences Encyclopedia
1
24
.
Albert C. LoPeter Guarino, Hermano I. Krebs, Bruce T. Volpe, Christopher T. Bever, Pamela W. Duncan, Robert J. Ringer, Todd H. Wagner, Lorie G. Richards, Dawn M. Bravata, Jodie K. Haselkorn, George F. Wittenberg, Daniel G. Federman, Barbara H. Corn, Alysia D. Maffucci & Peter Peduzzi. (2009) Multicenter Randomized Trial of Robot-Assisted Rehabilitation for Chronic Stroke: Methods and Entry Characteristics for VA ROBOTICS. Neurorehabilitation and Neural Repair 23:8, pages 775-783.
Crossref
Werner Brannath, Emmanuel Zuber, Michael Branson, Frank Bretz, Paul Gallo, Martin Posch & Amy Racine‐Poon. (2009) Confirmatory adaptive designs with Bayesian decision tools for a targeted therapy in oncology. Statistics in Medicine 28:10, pages 1445-1463.
Crossref
Antje Jahn-Eimermacher & Katharina Ingel. (2009) Adaptive trial design: A general methodology for censored time to event data. Contemporary Clinical Trials 30:2, pages 171-177.
Crossref
Ming T. Tan. 2007. Wiley Encyclopedia of Clinical Trials. Wiley Encyclopedia of Clinical Trials
1
7
.
Marc Vandemeulebroecke. (2008) Group Sequential and Adaptive Designs – A Review of Basic Concepts and Points of Discussion. Biometrical Journal 50:4, pages 541-557.
Crossref
David M. Reboussin. 2007. Wiley Encyclopedia of Clinical Trials. Wiley Encyclopedia of Clinical Trials
1
4
.
Susan Todd. 2007. Wiley Encyclopedia of Clinical Trials. Wiley Encyclopedia of Clinical Trials.
Gernot Wassmer. 2007. Wiley Encyclopedia of Clinical Trials. Wiley Encyclopedia of Clinical Trials.
Y. Shen & Y. Cheng. (2006) Adaptive design: estimation and inference with censored data in a semiparametric model. Biostatistics 8:2, pages 306-322.
Crossref
Xiaoping Xiong, Ming Tan & James Boyett. (2006) A sequential procedure for monitoring clinical trials against historical controls. Statistics in Medicine 26:7, pages 1497-1511.
Crossref
Madhu Mazumdar & Heejung Bang. 2007. Epidemiology and Medical Statistics. Epidemiology and Medical Statistics
491
512
.
Gernot Wassmer. 2004. Encyclopedia of Statistical Sciences. Encyclopedia of Statistical Sciences
1
14
.
A Hussein & K C Carriere. (2016) On group sequential procedures under variance heterogeneity. Statistical Methods in Medical Research 14:2, pages 121-128.
Crossref
John M. Lachin, Samuel W. Greenhouse & Oliver M. Bautista. (2003)
Group sequential large sample
T
2
‐like
χ
2
tests for multivariate observations
. Statistics in Medicine 22:21, pages 3357-3368.
Crossref
Madhu Mazumdar & Aiyi Liu. (2003) Group sequential design for comparative diagnostic accuracy studies. Statistics in Medicine 22:5, pages 727-739.
Crossref
Nigel Stallard & Susan Todd. (2003) Sequential designs for phase III clinical trials incorporating treatment selection. Statistics in Medicine 22:5, pages 689-703.
Crossref
Bart Spiessens, Emmanuel Lesaffre & Geert Verbeke. (2003) A comparison of group sequential methods for binary longitudinal data. Statistics in Medicine 22:4, pages 501-515.
Crossref
KyungMann Kim, Anastasios A. Tsiatis & Cyrus R. Mehta. (2003) 4. Sequential Methods for Biomedical Applications. Journal of the Japanese Society of Computational Statistics 15:2, pages 153-167.
Crossref
Susan Todd, Anne Whitehead, Nigel Stallard & John Whitehead. (2002) Interim analyses and sequential designs in phase III studies. British Journal of Clinical Pharmacology 51:5, pages 394-399.
Crossref
Peter F. Thall & Su‐Chun Cheng. (2001) Optimal two‐stage designs for clinical trials based on safety and efficacy. Statistics in Medicine 20:7, pages 1023-1032.
Crossref
John Whitehead, Anne Whitehead, Susan Todd, Kim Bolland & M. Roshini Sooriyarachchi. (2001) Mid-trial design reviews for sequential clinical trials. Statistics in Medicine 20:2, pages 165-176.
Crossref
Julia Brown, Damien McElvenny, Jane Nixon, Jackie Bainbridge & Su Mason. (2000) Some practical issues in the design, monitoring and analysis of a sequential randomized trial in pressure sore prevention. Statistics in Medicine 19:24, pages 3389-3400.
Crossref
Kim Bolland & John Whitehead. (2000) Formal approaches to safety monitoring of clinical trials in life-threatening conditions. Statistics in Medicine 19:21, pages 2899-2917.
Crossref
Bart SpiessensEmmanuel Lesaffre, Geert Verbeke, KyungMann Kim & David L DeMets. (2016) An overview of group sequential methods in longitudinal clinical trials. Statistical Methods in Medical Research 9:5, pages 497-515.
Crossref
Shigeyuki Matsui, Hajime Uno & Nobuyuki Koyama. (2000) Frequentist Approaches to Interim Monitoring of Clinical Trials: A Review of Recent Theoretical Developments. Japanese Journal of Biometrics 21:Special_Issue, pages S87-S124.
Crossref
Peter F. Thall & Su‐Chun Chengt. (2004) Treatment Comparisons Based on Two‐Dimensional Safety and Efficacy Alternatives in Oncology Trials. Biometrics 55:3, pages 746-753.
Crossref