Testing One Primary and Two Secondary Endpoints in a Two‐Stage Group Sequential Trial With Extensions
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DOI: 10.1002/sim.10346
Abstract: We study the problem of testing multiple secondary endpoints conditional on a primary endpoint being significant in a two‐stage group sequential procedure, focusing on two secondary endpoints. This extends our previous work with one secondary… read more here.
Keywords: secondary endpoints; normal theory; stage group; two secondary ... See more keywords
Asymmetric inner wedge group sequential tests with applications to verifying whether effective drug concentrations are similar in adults and children.
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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… read more here.
Keywords: sequential tests; group; group sequential; drug ... See more keywords
Group sequential comparison of positive predictive value curves for correlated biomarker data.
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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… read more here.
Keywords: positive predictive; group sequential; test; predictive value ... See more keywords
Group sequential design for randomized trials using “first hitting time” model
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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… read more here.
Keywords: sequential design; first hitting; design; model ... See more keywords
Group sequential methods for interim monitoring of randomized clinical trials with time‐lagged outcome
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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… read more here.
Keywords: time; clinical trials; interim analysis; trials time ... See more keywords
Group sequential multi‐arm multi‐stage trial design with treatment selection
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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… read more here.
Keywords: multi; multi arm; group sequential; trial ... See more keywords
GSNet: Group Sequential Learning for Image Recognition
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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… read more here.
Keywords: recognition; sequential learning; image; group sequential ... See more keywords
On selecting the critical boundary functions in group-sequential trials with two time-to-event outcomes.
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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… read more here.
Keywords: two time; time event; group sequential; critical boundary ... See more keywords
A randomized group sequential enrichment design for immunotherapy and targeted therapy.
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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… read more here.
Keywords: group sequential; design; enrichment; targeted therapy ... See more keywords
Increasing the efficiency of clinical trials in neurodegenerative disorders using group sequential trial designs.
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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… read more here.
Keywords: trials neurodegenerative; trial; neurodegenerative disorders; group sequential ... See more keywords
Planning the duration of a survival group sequential trial with a fixed follow-up time for all subjects
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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… read more here.
Keywords: trial; duration; survival group; time ... See more keywords