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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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.
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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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Being Efficient About Efficacy Estimation
TL;DR: It is concluded that there are simple things the authors could be doing to reduce the cost with which information is obtained in drug development and three approaches to improving efficiency are considered.
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Comparison of different clinical development plans for confirmatory subpopulation selection.
TL;DR: This work compares three clinical development plans for a time-to-event endpoint that all lead to a decision in a pivotal trial either in all comers only, in allcomers and biomarker positive, in the biomarkerpositive only, or to declare the drug futile.
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Adaptive Design Practice at the Center for Devices and Radiological Health (CDRH), January 2007 to May 2013:
Xiting Yang,Laura Thompson,Jianxiong Chu,Sherry Liu,Hong Lu,Jie Zhou,Shanti V. Gomatam,Rong Tang,Yu Zhao,Yunjiang Ge,Gerry Gray +10 more
TL;DR: The overall results and findings that emerged from an in-depth examination of adaptive design applications submitted between 2007 and May 2013 are discussed.
Journal ArticleDOI
An approach to the conditional error rate principle with nuisance parameters.
TL;DR: The conditional error rate principle is proposed to be used with nuisance parameters to search among tests that guarantee overall error control for the test that maximizes a weighted combination of the conditional error rates over possible values of the nuisance parameters.
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Integrated phase II/III clinical trials in oncology: a case study.
Meihua Wang,James J. Dignam,James J. Dignam,Qiang E Zhang,John DeGroot,Minesh P. Mehta,Sally Hunsberger +6 more
TL;DR: Although integrated phase II/III designs should not be used in all situations, under appropriate conditions, significant gains can be achieved when using integrated phase III designs, including smaller sample size, time and resources savings, and shorter study duration.