Journal ArticleDOI
67A Designed extension of studies based on conditional power
Reads0
Chats0
TLDR
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
More filters
Journal ArticleDOI
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.
Posted Content
Adaptive Survival Trials
TL;DR: In this paper, the authors proposed an alternative test incorporating allevent times, where a conservative assumption is made in order to guarantee typeI error control. But, their approach may ignore a substantial subset of the observed event times, since it is the earliest recruited patients that is ignored.
Journal ArticleDOI
Estimation of treatment effect following a clinical trial with adaptive design.
TL;DR: This paper introduces a new framework to model clinical trial data flow based on a marked point process (MPP), which allows us to use methods of stochastic calculus for analyses of any adaptive clinical trial.
Journal ArticleDOI
On flexibility of adaptive designs and criteria for choosing a good one--a discussion of FDA draft guidance.
Bin Cheng,Shein-Chung Chow +1 more
TL;DR: This discussion paper further classify the less well-understood adaptive designs into the categories of flexible and wildly flexible ones and recommend the latter not be used and suggests a set of performance characteristics as criteria for choosing a good design from a pool of flexible adaptive designs and group sequential designs.
Dissertation
Design issues and extensions of multi-arm multi-stage clinical trials
TL;DR: The MAMS design, which compares multiple new treatments against a control in a single trial, obviating the need for multiple two-arm studies, and ceases recruitment to poorly performing arms during the study is extended to other types of outcome measure such as binary.
References
More filters
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 Designs in Clinical Drug Development—An Executive Summary of the PhRMA Working Group
TL;DR: Three particular areas where it is felt that adaptive designs can be utilized beneficially are discussed: dose finding, seamless Phase II/III trials designs, and sample size reestimation.
Journal ArticleDOI
Adaptive increase in sample size when interim results are promising: a practical guide with examples.
Cyrus R. Mehta,Stuart J. Pocock +1 more
TL;DR: The benefits and limitations of adaptive sample size re-estimation for phase 3 confirmatory clinical trials are discussed and those promising circumstances in which a conventional final inference can be performed while preserving the overall type-1 error are defined.