Group sequential design for randomized trials using “first hitting time” model

Chen, Yiming; Lawrence, John; Lee, Mei‐Ling Ting

doi:10.1002/sim.9360

Group sequential design for randomized trials using “first hitting time” model

Journal Article · 10 March 2022 · Statistics in Medicine

DOI:https://doi.org/10.1002/sim.9360· OSTI ID:1981435

Chen, Yiming ^[1]; ^[2]; ^[3]

Department of Epidemiology and Biostatistics University of Maryland College Park Maryland USA; ORISE, Center for Drug Evaluation and Research U.S. Food and Drug Administration Silver Spring Maryland USA
Center for Drug Evaluation and Research U.S. Food and Drug Administration Silver Spring Maryland USA
Department of Epidemiology and Biostatistics University of Maryland College Park Maryland USA

Not provided.

Research Organization:: Oak Ridge Institute for Science and Education (ORISE), Oak Ridge, TN (United States)

Sponsoring Organization:: USDOE Office of Science (SC)

DOE Contract Number:: SC0014664

OSTI ID:: 1981435

Journal Information:: Statistics in Medicine, Journal Name: Statistics in Medicine Journal Issue: 13 Vol. 41; ISSN 0277-6715

Publisher:: Wiley

Country of Publication:: United States

Language:: English

References (30)

Estimating dose-response for time to remission with instrumental variable adjustment: the obscuring effects of drug titration in Genome Based Therapeutic Drugs for Depression Trial (GENDEP): clinical trial data Hellier, Jennifer; Emsley, Richard; Pickles, Andrew Trials, Vol. 21, Issue 1 https://doi.org/10.1186/s13063-019-3810-9	journal	January 2020
Restricted mean survival time: an alternative to the hazard ratio for the design and analysis of randomized trials with a time-to-event outcome Royston, Patrick; Parmar, Mahesh KB BMC Medical Research Methodology, Vol. 13, Issue 1 https://doi.org/10.1186/1471-2288-13-152	journal	December 2013
Methods for Accommodating Nonproportional Hazards in Clinical Trials: Ready for the Primary Analysis? Freidlin, Boris; Korn, Edward L. Journal of Clinical Oncology, Vol. 37, Issue 35 https://doi.org/10.1200/JCO.19.01681	journal	December 2019
Information and information fractions for design and sequential monitoring of clinical trials Gordon Lan, K. K.; Reboussin, David M.; DeMets, David L. Communications in Statistics - Theory and Methods, Vol. 23, Issue 2 https://doi.org/10.1080/03610929408831263	journal	January 1994
Sequential methods for parametric survival models Tsiatis, A. A.; Boucher, H.; Kim, K. Biometrika, Vol. 82, Issue 1 https://doi.org/10.1093/biomet/82.1.165	journal	March 1995
Versatile Tests for Comparing Survival Curves Based on Weighted Log-rank Statistics Karrison, Theodore G. The Stata Journal: Promoting communications on statistics and Stata, Vol. 16, Issue 3 https://doi.org/10.1177/1536867X1601600308	journal	September 2016
Sequential tests for non-proportional hazards data Brückner, Matthias; Brannath, Werner Lifetime Data Analysis, Vol. 23, Issue 3 https://doi.org/10.1007/s10985-016-9360-5	journal	March 2016
Sample-Size Formula for the Proportional-Hazards Regression Model Schoenfeld, David A. Biometrics, Vol. 39, Issue 2 https://doi.org/10.2307/2531021	journal	June 1983
Adaptive designs undertaken in clinical research: a review of registered clinical trials Hatfield, Isabella; Allison, Annabel; Flight, Laura Trials, Vol. 17, Issue 1 https://doi.org/10.1186/s13063-016-1273-9	journal	March 2016
The Hazards of Hazard Ratios Hernán, Miguel A. Epidemiology, Vol. 21, Issue 1 https://doi.org/10.1097/EDE.0b013e3181c1ea43	journal	January 2010
A regression method for censored inverse-Gaussian data Whitmore, G. A. Canadian Journal of Statistics, Vol. 11, Issue 4 https://doi.org/10.2307/3314888	journal	December 1983
Semiparametric Efficiency and its Implication on the Design and Analysis of Group-Sequential Studies Scharfstein, Daniel O.; Tsiatis, Anastasios A.; Robins, James M. Journal of the American Statistical Association, Vol. 92, Issue 440 https://doi.org/10.1080/01621459.1997.10473655	journal	December 1997
Discrete sequential boundaries for clinical trials Gordon Lan, K. K.; Demets, David L. Biometrika, Vol. 70, Issue 3 https://doi.org/10.1093/biomet/70.3.659	journal	January 1983
Maximum of the Weighted Kaplan-Meier Tests with Application to Cancer Prevention and Screening Trials Shen, Yu; Cai, Jianwen Biometrics, Vol. 57, Issue 3 https://doi.org/10.1111/j.0006-341X.2001.00837.x	journal	September 2001
A Threshold Regression Mixture Model for Assessing Treatment Efficacy in a Multiple Myeloma Clinical Trial Lee, Mei-Ling Ting; Chang, Mark; Whitmore, G. A. Journal of Biopharmaceutical Statistics, Vol. 18, Issue 6 https://doi.org/10.1080/10543400802398524	journal	November 2008
Alternative Analysis Methods for Time to Event Endpoints Under Nonproportional Hazards: A Comparative Analysis Lin, Ray S.; Lin, Ji; Roychoudhury, Satrajit Statistics in Biopharmaceutical Research, Vol. 12, Issue 2 https://doi.org/10.1080/19466315.2019.1697738	journal	January 2020
Threshold Regression for Time-to-Event Analysis: The Stthreg Package Xiao, Tao; Whitmore, G. A.; He, Xin The Stata Journal: Promoting communications on statistics and Stata, Vol. 12, Issue 2 https://doi.org/10.1177/1536867X1201200206	journal	June 2012
Methodology and Application of Adaptive and Sequential Approaches in Contemporary Clinical Trials Chen, Zhengjia; Zhao, Yichuan; Cui, Ye Journal of Probability and Statistics, Vol. 2012 https://doi.org/10.1155/2012/527351	journal	January 2012
Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan-Meier survival curves Guyot, Patricia; Ades, Ae; Ouwens, Mario JNM BMC Medical Research Methodology, Vol. 12, Issue 1 https://doi.org/10.1186/1471-2288-12-9	journal	February 2012
Group sequential tests with censored survival data adjusting for covariates Tsiatis, Anastasios A.; Rosner, Gary L.; Tritchler, David L. Biometrika, Vol. 72, Issue 2 https://doi.org/10.1093/biomet/72.2.365	journal	January 1985
Sequential Methods in Clinical Trials* Whitehead, John Sequential Analysis, Vol. 21, Issue 4 https://doi.org/10.1081/SQA-120016303	journal	January 2002
Gefitinib or Carboplatin–Paclitaxel in Pulmonary Adenocarcinoma Mok, Tony S.; Wu, Yi-Long; Thongprasert, Sumitra New England Journal of Medicine, Vol. 361, Issue 10 https://doi.org/10.1056/NEJMoa0810699	journal	September 2009
Analyzing survival curves at a fixed point in time Klein, John P.; Logan, Brent; Harhoff, Mette Statistics in Medicine, Vol. 26, Issue 24 https://doi.org/10.1002/sim.2864	journal	January 2007
A simulation‐free group sequential design with max‐combo tests in the presence of non‐proportional hazards Wang, Lili; Luo, Xiaodong; Zheng, Cheng Pharmaceutical Statistics, Vol. 20, Issue 4 https://doi.org/10.1002/pst.2116	journal	March 2021
Group sequential monitoring based on the weighted log-rank test statistic with the Fleming-Harrington class of weights in cancer vaccine studies Hasegawa, Takahiro Pharmaceutical Statistics, Vol. 15, Issue 5 https://doi.org/10.1002/pst.1760	journal	June 2016
Threshold Regression for Survival Analysis: Modeling Event Times by a Stochastic Process Reaching a Boundary Lee, Mei-Ling Ting; Whitmore, G. A. Statistical Science, Vol. 21, Issue 4 https://doi.org/10.1214/088342306000000330	journal	November 2006
A Multiple Testing Procedure for Clinical Trials O'Brien, Peter C.; Fleming, Thomas R. Biometrics, Vol. 35, Issue 3 https://doi.org/10.2307/2530245	journal	September 1979
A 25-year review of sequential methodology in clinical studies Todd, Susan Statistics in Medicine, Vol. 26, Issue 2 https://doi.org/10.1002/sim.2763	journal	January 2006
Robust Design and Analysis of Clinical Trials With Nonproportional Hazards: A Straw Man Guidance From a Cross-Pharma Working Group Roychoudhury, Satrajit; Anderson, Keaven M.; Ye, Jiabu Statistics in Biopharmaceutical Research, Vol. 15, Issue 2 https://doi.org/10.1080/19466315.2021.1874507	journal	March 2021
Proportional hazards and threshold regression: their theoretical and practical connections Lee, Mei-Ling Ting; Whitmore, G. A. Lifetime Data Analysis, Vol. 16, Issue 2 https://doi.org/10.1007/s10985-009-9138-0	journal	December 2009

Similar Records

Consideration of the adaptive randomization allocation ratio in the presence of treatment group heteroscedasticity in clinical trials

Journal Article · 2022 · Journal of Biopharmaceutical Statistics · OSTI ID:1982425

Delivery of lethal hits by cytotoxic T lymphocytes in multicellular conjugates occurs sequentially but at random times

Journal Article · 1982 · J. Immunol.; (United States) · OSTI ID:6173244

Random sequential adsorption and its long-time limit

Journal Article · 2018 · American Journal of Physics · OSTI ID:1609680

Related Subjects

Mathematical & Computational Biology
Mathematics
Medical Informatics
Public
Environmental & Occupational Health
Research & Experimental Medicine

Group sequential design for randomized trials using “first hitting time” model

Citation Formats

References (30)

Similar Records

Related Subjects