Results 11 to 20 of about 353,062 (253)
Adaptive designs in critical care trials: a simulation study
BMC Medical Research Methodology, 2023 Background Adaptive clinical trials are growing in popularity as they are more flexible, efficient and ethical than traditional fixed designs. However, notwithstanding their increased use in assessing treatments for COVID-19, their use in critical care ...
W. Li +4 more
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Considerations in Adapting Clinical Trial Design
Journal of the Formosan Medical Association, 2008 The concept of adaptation of trial design during the course of a clinical trial has recently drawn much interest from the pharmaceutical industry. The interest arises partly because statistical decision trees employed to address multiple complex clinical
H.M. James Hung
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BMC Medical Research Methodology, 2023 Background Trial design plays a key role in clinical trials. Traditional group sequential design has been used in cardiovascular clinical trials over decades as the trials can potentially be stopped early, therefore, it can reduce pre-planned sample size
Jufen Zhang, Christy Saju
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Group Sequential Designs: A Tutorial
, 2021 This tutorial illustrates how to design, analyze, and report group sequential designs. In these designs, groups of observations are collected and repeatedly analyzed, while controlling error rates. Compared to a fixed sample size design, where data is analyzed only once, group sequential designs offer the possibility to stop the study at interim looks ...
Daniel Lakens +2 more
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A practical simulation method to calculate sample size of group sequential trials for time-to-event data under exponential and Weibull distribution. [PDF]
PLoS ONE, 2012 Group sequential design has been widely applied in clinical trials in the past few decades. The sample size estimation is a vital concern of sponsors and investigators.
Zhiwei Jiang +4 more
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Group sequential designs for negative binomial outcomes [PDF]
Statistical Methods in Medical Research, 2018 Count data and recurrent events in clinical trials, such as the number of lesions in magnetic resonance imaging in multiple sclerosis, the number of relapses in multiple sclerosis, the number of hospitalizations in heart failure, and the number of exacerbations in asthma or in chronic obstructive pulmonary disease (COPD) are often modeled by negative ...
Tobias Mütze +3 more
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Journal of Statistical Software, 2016 The R package gsbDesign provides functions to evaluate the operating characteristics of Bayesian group sequential clinical trial designs. More specifically, we consider clinical trials with interim analyses, which compare a treatment with a control, and ...
Florian Gerber, Thomas Gsponer
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Comparison of Bayesian and frequentist group-sequential clinical trial designs
BMC Medical Research Methodology, 2020 Background There is a growing interest in the use of Bayesian adaptive designs in late-phase clinical trials. This includes the use of stopping rules based on Bayesian analyses in which the frequentist type I error rate is controlled as in frequentist ...
Nigel Stallard +3 more
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Trials, 2020 Background Phase III trials often require large sample sizes, leading to high costs and delays in clinical decision-making. Group sequential designs can improve trial efficiency by allowing for early stopping for efficacy and/or futility and thus may ...
Elizabeth G. Ryan +5 more
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OptGS: An R Package for Finding Near-Optimal Group-Sequential Designs
Journal of Statistical Software, 2015 A group-sequential clinical trial design is one in which interim analyses of the data are conducted after groups of patients are recruited. After each interim analysis, the trial may stop early if the evidence so far shows the new treatment is ...
James Wason
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