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A gated group sequential design for seamless Phase II/III trial with subpopulation selection [PDF]

open access: yesBMC Medical Research Methodology, 2023
Background Due to the high cost and high failure rate of Phase III trials where a classical group sequential design (GSD) is usually used, seamless Phase II/III designs are more and more popular to improve trial efficiency.
Guanhong Miao   +3 more
doaj   +2 more sources

Bayesian dynamic borrowing in group-sequential design for medical device studies [PDF]

open access: yesBMC Medical Research Methodology
Background The integration of historical data into ongoing clinical trials through Bayesian Dynamic Borrowing offers significant advantages, including reduced sample size, trial duration, and associated costs.
Maria Vittoria Chiaruttini   +2 more
doaj   +2 more sources

Testing a primary and a secondary endpoint in a group sequential design. [PDF]

open access: yesBiometrics, 2010
Summary We consider a clinical trial with a primary and a secondary endpoint where the secondary endpoint is tested only if the primary endpoint is significant. The trial uses a group sequential procedure with two stages.
Tamhane AC, Mehta CR, Liu L.
europepmc   +4 more sources

Benefits of group sequential design and sample size re-estimation for randomised controlled trials evaluating the prevention of ventilator-associated pneumonia: a simulation study informed by real world data [PDF]

open access: yesBMC Medical Research Methodology
Background Ventilator-associated pneumonia (VAP) is an important healthcare acquired infection, which is associated with high morbidity and mortality. Conducting conventional randomised controlled trials (RCTs) on VAP prevention is often challenging, due
Holly Jackson   +4 more
doaj   +2 more sources

临床试验中的成组序贯设计 Group Sequential Design in Clinical Trials

open access: yesZhongguo cuzhong zazhi, 2022
近年来,成组序贯设计因其可在期中分析时提前得出结论结束试验,具有更强的灵活性,已被广泛应用于临床试验中。本文将从背景、设计思路、与传统临床试验的比较、使用场景、案例解读、设计要点和报告规范等对该方法进行简单介绍。 Abstract: In recent years, the group sequential design has been widely used in clinical trials, because this design can draw conclusions in ...
胥芹, 张怡君, 田雪, 夏雪, 张晓丽, 李静, 王安心
doaj   +1 more source

Group sequential two‐stage preference designs

open access: yesStatistics in Medicine, 2023
The two‐stage preference design (TSPD) enables inference for treatment efficacy while allowing for incorporation of patient preference to treatment. It can provide unbiased estimates for selection and preference effects, where a selection effect occurs when patients who prefer one treatment respond differently than those who prefer another, and a ...
Ruyi Liu   +3 more
openaire   +4 more sources

Optimality criteria for futility stopping boundaries for group sequential designs with a continuous endpoint

open access: yesBMC Medical Research Methodology, 2020
Background In clinical trials with fixed study designs, statistical inference is only made when the trial is completed. In contrast, group sequential designs allow an early stopping of the trial at interim, either for efficacy when the treatment effect ...
Xieran Li   +2 more
doaj   +1 more source

Group sequential designs applied in psychological research [PDF]

open access: yesMethodology, 2020
Psychological research is confronted with ever-increasing demands to save resources such as time and money while assuring high ethical standards. In medical and pharmaceutical research, group sequential designs have fundamentally changed traditional statistical testing approaches featuring only one analysis at the end of a single-stage study.
Weigl, Klemens, Ponocny, Ivo
openaire   +3 more sources

Transaction cost of micro and small enterprises financing

open access: yesEconomic Journal of Emerging Markets, 2016
High transaction costs become one of the obstacles for the micro and small enterprises (MSEs) to access financial loans to the bank. In order to minimize the transaction costs, group lending scheme become  alternative, so that both sides are pay lower ...
Ghana Atma Sulistya, Darwanto Darwanto
doaj   +13 more sources

The effect of a sequential structure of practice for the training of perceptual-cognitive skills in tennis. [PDF]

open access: yesPLoS ONE, 2017
OBJECTIVE:Anticipation of opponent actions, through the use of advanced (i.e., pre-event) kinematic information, can be trained using video-based temporal occlusion.
David P Broadbent   +4 more
doaj   +1 more source

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