• 제목/요약/키워드: group sequential designs

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Accuracy of Brownian Motion Approximation in Group Sequential Methods

  • Euy Hoon Suh
    • Communications for Statistical Applications and Methods
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    • 제6권1호
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    • pp.207-220
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    • 1999
  • In this paper, some of the issue about a group sequential method are considered in the Bayesian context. The continuous time optimal stopping boundary can be used to approximate the optimal stopping boundary for group sequential designs. The exact stopping boundary for group sequential design is obtained by using the backward induction method and is compared with the continuous optimal stopping boundary and the corrected continuous stopping boundary.

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Monitoring of Clinical Trials: Issues and Recammendations

  • Fleming Thomas R.;Demets David L.
    • 대한예방의학회:학술대회논문집
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    • 대한예방의학회 1994년도 교수 연수회(역학)
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    • pp.270-284
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    • 1994
  • Interim analyses of randomized trials enable investigators to make more efficient use of limited research resources and to satisfy ethical requirements that a regimen be discontinued as soon as it has been established to have an inferior efficacy/toxicity profile. Unfortunately. the integrity and credibility of these trials can be compromised if inappropriate procedures are used in monitoring interim data. 'In this paper we discuss how group sequential designs provide useful guidelines that enable one to satisfy the valid objectives of interim monitoring while avoiding undesirable consequences, and we consider how flexible one can be in the way such designs are implemented. We also provide motivation for the role of data-monitoring committees in preserving study integrity and credibility in either government- or industry-sponsored trials. In our view. these committees should have multidisciplinary representation and membership limited to individuals free of apparent significant conflict of interest, and ideally should be the only individuals to whom the data analysis center provides interim results on relative efficacy of treatment regimens. Finally. we discuss some important practical issues such as estimation following group sequential testing, anal ysis of secondary outcomes after using a group sequential design applied to a primary outcome, early stopping of negative trials. and the role of administrative analyses.

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Estimation of Maximal Tolerated Dose in Sequential Phase I Clinical Trials

  • Park, In-Hye;Song, Hae-Hiang
    • Communications for Statistical Applications and Methods
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    • 제6권2호
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    • pp.543-564
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    • 1999
  • The principal aim of a sequential phase I clinical trial in which the toxicity reponses of a group of patient(s) determine the dose level of the next patient(s) group is to estimate the maximal tolerated dose(MTD) of a new drug, In this paper we compared with a simulation study the performance of the MTD estimates that are determined by a stopping rule in a design and also those that are determined by analyzing the data after a clinical trial is terminated. To the latter belong the mean median mode and maximum likelihood estimates. For the Standard Methods the stopping rule MTD is quite inefficient but the median MTD has a best efficiency and is robust with respect to the three different toxicity curves. The problem of non-convergence of MLE MTD is severe. A more improved MTD estimate is produced by combining the advantages of the various MTD estimates and its efficiency is better than the single median MTD estimate especially for the toxicity curve of an unlucky choice of dose levels. The simulation results suggest that simple types of phase I designs can be combined with relatively standard analytic techniques to provide a more efficient MTD estimate.

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Designing an Electronic Course and Its Impact on Developing University Students' Computational Thinking Skills

  • Al-Zahrani, Majed bin Maili bin Mohammad
    • International Journal of Computer Science & Network Security
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    • 제22권1호
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    • pp.15-20
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    • 2022
  • The study investigated the effects of differences in some electronic course designs on university students' Computational Thinking Skills (CTS). Towards this end, the researcher adopted the experimental research design of a quasi-experimental of two experimental groups. The first group was taught an e-course designed in a sequential pattern, and the other group's course was designed according to the holistic model. A CTSs test was prepared to collect the relevant data, and the data were analyzed statistically using these tests- Pearson correlation Mann Whitney and Alpha Cronbach. Results revealed statistically-significant differences at the level α=0.05 between the mean scores of the first and second experimental groups in favor of the latter in the CTS test. The findings gave ground to put forward some salient recommendations, including the need to expand computational thinking in universities' educational process. It also recommends urging faculty members to enhance e-courses in the educational process and provide technical support to students and faculty members.

Effects of Differences in Electronic Course Design on University Students' Programming Skills

  • Al-Zahrani, Majed bin Maili bin Mohammad
    • International Journal of Computer Science & Network Security
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    • 제22권1호
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    • pp.21-26
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    • 2022
  • This study touched on the effect of the different electronic course designs on the programming skills of university students. The researcher used the experimental research design of a quasi-experimental of two experimental groups to achieve the objectives of the study. The first group underwent an electronic course designed in the holistic pattern, and the second group was taught a course in a sequential pattern. This experimental design was intended to measure the impact of these two learning modes on the learners' cognitive and performance achievement of programming skills. An achievement test and observational form were the data collection tools. Data were analyzed statistically using Pearson correlation, Mann Whitney Test, and Alpha Cronbach. The findings revealed statistically- significant differences between the mean scores of the students of the first and second experimental groups in favor of the former concerning the observational form and the latter in the cognitive test. Based on the findings, some recommendations are suggested. Due to their effectiveness in the educational process, expanding using the e-courses at universities is vital. The university teachers are highly recommended to design e-courses and provide technical and material support to the e-courses user to fulfill their design purpose.