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Published in 2017 at "Statistics in medicine"
DOI: 10.1002/sim.7154
Abstract: Extrapolating from information available on one patient group to support conclusions about another is common in clinical research. For example, the findings of clinical trials, often conducted in highly selective patient cohorts, are routinely extrapolated…
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Keywords:
sequential tests;
group;
group sequential;
drug ... See more keywords
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Published in 2020 at "Statistics in medicine"
DOI: 10.1002/sim.8509
Abstract: Clinical studies of predictive diagnostic tests consider the evaluation of a single test and comparison of two tests regarding their predictive accuracy of disease status. The positive predictive value (PPV) curve is used for assessing…
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Keywords:
positive predictive;
group sequential;
test;
predictive value ... See more keywords
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Published in 2022 at "Statistics in Medicine"
DOI: 10.1002/sim.9360
Abstract: Group sequential design (GSD) has become a popular choice in recent clinical trials as it improves trial efficiency by providing options for early termination. The implementation of traditional tests for survival analysis (eg, the log‐rank…
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Keywords:
sequential design;
first hitting;
design;
model ... See more keywords
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Published in 2022 at "Statistics in Medicine"
DOI: 10.1002/sim.9580
Abstract: The primary analysis in two‐arm clinical trials usually involves inference on a scalar treatment effect parameter; for example, depending on the outcome, the difference of treatment‐specific means, risk difference, risk ratio, or odds ratio. Most…
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Keywords:
time;
clinical trials;
interim analysis;
trials time ... See more keywords
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Published in 2023 at "Statistics in Medicine"
DOI: 10.1002/sim.9682
Abstract: A multi‐arm trial allows simultaneous comparison of multiple experimental treatments with a common control and provides a substantial efficiency advantage compared to the traditional randomized controlled trial. Many novel multi‐arm multi‐stage (MAMS) clinical trial designs…
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Keywords:
multi;
multi arm;
group sequential;
trial ... See more keywords
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Published in 2021 at "Cognitive Computation"
DOI: 10.1007/s12559-020-09815-4
Abstract: In recent years, deep learning has achieved great successes in the field of image cognitive learning, and designing a well-behaved convolutional neural network (CNN)-based architecture has become a challenging and important problem. The traditional group…
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Keywords:
recognition;
sequential learning;
image;
group sequential ... See more keywords
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Published in 2020 at "Contemporary clinical trials"
DOI: 10.1016/j.cct.2020.106244
Abstract: We investigate selection of critical boundary functions for testing the hypotheses of two time-to-event outcomes as both primary endpoints or a primary and a secondary endpoint in group-sequential clinical trials, where (1) the effect sizes…
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Keywords:
two time;
time event;
group sequential;
critical boundary ... See more keywords
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Published in 2022 at "Contemporary clinical trials"
DOI: 10.1016/j.cct.2022.106742
Abstract: In targeted therapy or immunotherapy, it is common that only a subpopulation of patients are sensitive to and thus may benefit from the therapy. In practice, based on pre-clinical data, it is often assumed that…
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Keywords:
group sequential;
design;
enrichment;
targeted therapy ... See more keywords
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Published in 2018 at "Journal of clinical epidemiology"
DOI: 10.1016/j.jclinepi.2018.02.013
Abstract: OBJECTIVES Clinical trials in neurodegenerative disorders are facing high futility rates and rising development costs. We aim to review and exemplify the value of group sequential trial designs (i.e., designs with one or more prospectively…
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Keywords:
trials neurodegenerative;
trial;
neurodegenerative disorders;
group sequential ... See more keywords
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Published in 2017 at "Communications in Statistics - Theory and Methods"
DOI: 10.1080/03610926.2016.1152488
Abstract: ABSTRACT To explore the operation characteristics of survival group sequential trials with a fixed follow-up period, the accrual time and total trial duration to ensure power and type I error rate requirements are explained and…
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Keywords:
trial;
duration;
survival group;
time ... See more keywords
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Published in 2017 at "Journal of Biopharmaceutical Statistics"
DOI: 10.1080/10543406.2017.1282960
Abstract: Xia and Hoover (2007) proposed a group sequential clinical trial design for the trial with Poisson outcome. Although it is a very practical clinical trial problem, the presentation of the article is still facing some…
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Keywords:
trial;
group;
group sequential;
xia hoover ... See more keywords