Abstract:
:A useful testing strategy is proposed for a confirmatory phase III clinical trial. It consists of a combined test of superiority and test of equivalence, and it is easy to apply. By introducing the strategy, we can perform a post hoc analysis in a confirmatory experiment. Thus a more flexible decision will be possible than the usual single testing method provides. It is shown that the procedure needs no adjustment for multiplicity from the point of view of the closed testing procedure. The relationship between this strategy and a confidence interval is also discussed.
journal_name
J Biopharm Statjournal_title
Journal of biopharmaceutical statisticsauthors
Morikawa T,Yoshida Mdoi
10.1080/10543409508835115subject
Has Abstractpub_date
1995-11-01 00:00:00pages
297-306issue
3eissn
1054-3406issn
1520-5711journal_volume
5pub_type
杂志文章abstract::Highly clustered count data are commonly seen in medical device clinical studies such as cardiac rhythm management. For instance, anti-arrhythmia shocks delivered from an implantable cardioverter-defibrillator (ICD) often occur as "storms", i.e., multiple shocks within a short period of time. There are unique challeng...
journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1080/10543400701668241
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章,评审
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
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abstract::In this article, a parametric sequential test is proposed under the Weibull model. The proposed test is asymptotically normal with an independent increment structure. The sample size for a fixed sample test is derived for the purpose of group sequential trial design. In addition, a multi-stage group sequential procedu...
journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
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abstract::Four multidose animal carcinogenicity assay trend test procedures based on the chi-square, Hoel-Walburg, log-rank, and Peto procedures are compared under conditions of competing risks. A total of 42 different risk populations are simulated in which a simulated animal can contract one or more of five different tumor ty...
journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1080/10543409408835089
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1080/10543406.2010.508139
更新日期:2012-01-01 00:00:00
abstract::Historical control trials (HCTs) are frequently conducted to compare an experimental treatment with a control treatment from a previous study, when they are applicable and favored over a randomized clinical trial (RCT) due to feasibility, ethics and cost concerns. Makuch and Simon developed a sample size formula for h...
journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1080/10543406.2015.1052495
更新日期:2016-01-01 00:00:00
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1080/10543406.2019.1632877
更新日期:2020-03-01 00:00:00
abstract::Noninferiority multiregional clinical trials (MRCTs) have recently received increasing attention in drug development. While a major goal in an MRCT is to estimate the global treatment effect, it is also important to assess the consistency of treatment effects across multiple regions. In this paper, we propose an intui...
journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1080/10543406.2017.1293075
更新日期:2017-01-01 00:00:00
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1080/10543406.2014.924960
更新日期:2014-01-01 00:00:00
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1081/BIP-100107656
更新日期:2001-01-01 00:00:00
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1080/10543400601177426
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1081/BIP-100101981
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章,评审
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abstract::Multiple comparisons are commonly seen in clinical trials and many other fields. An example, which is the focus of this paper, is the comparison of several test treatments (possibly different doses of a compound) with placebo (control). It is well known that steps must be taken to control the type I error rate when mu...
journal_title:Journal of biopharmaceutical statistics
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journal_title:Journal of biopharmaceutical statistics
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1080/10543406.2014.920858
更新日期:2015-01-01 00:00:00
abstract::The aim of this work is to quantitatively assess the impact of structural model misspecifications on the estimates of mean and interindividual variability of clearance in the context of population approaches. This assessment is conducted from simulated datasets. Our results show that impact magnitude of model misspeci...
journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1081/BIP-120028516
更新日期:2004-02-01 00:00:00
abstract::Tango (Biostatistics 2016) proposed a new repeated measures design called the S:T repeated measures design, combined with generalized linear mixed-effects models and sample size calculations for a test of the average treatment effect that depend not only on the number of subjects but on the number of repeated measures...
journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1080/10543406.2017.1293083
更新日期:2017-01-01 00:00:00
abstract::In randomized controlled trials, patients are recruited and randomly allocated to treatments. Patients are never randomly sampled from large population of patients on treatments under study. Therefore, it is important to consider the design and statistical analysis based on the randomization model. In this article, we...
journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
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更新日期:2009-01-01 00:00:00
abstract::This article discusses the design of a clinical trial where a new treatment will be compared to a control. For a specific type of endpoint, there are a wide variety of test statistics that can be used. Also, the investigator must decide how many patients to accrue in each arm as well as the duration of the study. Afte...
journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
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更新日期:2002-05-01 00:00:00
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1080/10543406.2013.792827
更新日期:2013-01-01 00:00:00
abstract::How long a dementia patient is cared for in the home before admission to a nursing home depends on the state of the patient and the state of the caregiver. Using 5-year follow-up data, the times until entry to nursing home and until death are modeled using a Cox survival model in which patient and caregiver variables ...
journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
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abstract::It is well known that there is strong relationship between HIV viral load and CD4 cell counts in AIDS studies. However, the relationship between them changes during the course of treatment and may vary among individuals. During treatments, some individuals may experience terminal events such as death. Because the term...
journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1080/10543406.2015.1052493
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