Journal ArticleDOI
67A Designed extension of studies based on conditional power
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A flexible method of extending a study based on conditional power, where the significance of the treatment difference at the planned end is used to determine the number of additional observations needed and the critical value necessary after accruing those additional observations.About:
This article is published in Controlled Clinical Trials.The article was published on 1995-06-01. It has received 252 citations till now. The article focuses on the topics: Extension (predicate logic).read more
Citations
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Journal ArticleDOI
Adaptive sample size calculations in group sequential trials.
Walter Lehmacher,Gernot Wassmer +1 more
TL;DR: A method for group sequential trials that is based on the inverse normal method for combining the results of the separate stages is proposed, which enables data-driven sample size reassessments during the course of the study.
Journal ArticleDOI
Modification of Sample Size in Group Sequential Clinical Trials
Lu Cui,H. M. J. Hung,S.-J. Wang +2 more
TL;DR: A new group sequential test procedure is developed by modifying the weights used in the traditional repeated significance two-sample mean test, which has the type I error probability preserved at the target level and can provide a substantial gain in power with the increase of sample size.
Journal ArticleDOI
Adaptive design methods in clinical trials – a review
Shein-Chung Chow,Mark Chang +1 more
TL;DR: Several commonly considered adaptive designs in clinical trials are reviewed and some examples concerning the development of Velcade intended for multiple myeloma and non-Hodgkin's lymphoma are given.
Journal ArticleDOI
Adaptive designs in clinical trials: why use them, and how to run and report them
Philip Pallmann,Alun Bedding,Babak Choodari-Oskooei,Munyaradzi Dimairo,Laura Flight,Lisa V. Hampson,Lisa V. Hampson,Jane Holmes,Adrian Mander,Lang’o Odondi,Matthew R. Sydes,Sofia S. Villar,James Wason,James Wason,Christopher J. Weir,Graham M. Wheeler,Graham M. Wheeler,Christina Yap,Thomas Jaki +18 more
TL;DR: This tutorial paper provides guidance on key aspects of adaptive designs that are relevant to clinical triallists, and emphasises the general principles of transparency and reproducibility and suggest how best to put them into practice.
Journal ArticleDOI
Adaptive Group Sequential Designs for Clinical Trials: Combining the Advantages of Adaptive and of Classical Group Sequential Approaches
Hans-Helge Müller,Helmut Schäfer +1 more
TL;DR: A general method is presented integrating the concept of adaptive interim analyses into classical group sequential testing to allow the researcher to represent every group sequential plan as an adaptive trial design and to make design changes during the course of the trial after every interim analysis.
References
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Journal ArticleDOI
Optimal flexible sample size design with robust power
TL;DR: It is concluded that to deal with the challenge of sample size determination due to effect size uncertainty, an optimal approach can help to select the best design that provides most robust power across the effect size range of interest.
Journal ArticleDOI
The Convolutional Group Sequential Test: Reducing Test Time for Evoked Potentials
TL;DR: This study presents an intuitive and flexible method for controlling the type-I error rate for sequentially applied statistical tests built around the discrete convolution of truncated probability density functions.
Journal ArticleDOI
Analysis of Two-Stage Adaptive Seamless Trial Design
TL;DR: An overview of statistical methods for analysis of different types of two-stage seamless adaptive designs is provided and a case study concerning the evaluation of a test treatment for treating hepatitis C infected patients utilizing type (IV) trial design is presented.
Book ChapterDOI
Designing, Monitoring, and Analyzing Group Sequential Clinical Trials Using the RCTdesign Package for R
TL;DR: This manuscript demonstrates how the RCTdesign package in R can be used to select, implement, and analyze a group sequential stopping rule and illustrates trial design and monitoring in the context of an experimental monoclonal antibody in patients with relapsed chronic lymphocytic leukemia.
Journal ArticleDOI
Bayesian Two-Stage Adaptive Design in Bioequivalence.
TL;DR: This work proposes a new Bayesian two-stage adaptive design that not only incorporates historical information and expert information, but further combines experimental data flexibly to aid decision-making and explores its application in bioequivalence testing.