Bootstrap multiple test procedure

1988 ◽  
Vol 15 (3) ◽  
pp. 335-339
Author(s):  
Tommy Johnsson
1992 ◽  
Vol 87 (417) ◽  
pp. 162-170 ◽  
Author(s):  
Charles W. Dunnett ◽  
Ajit C. Tamhane

2021 ◽  
pp. 096228022098693 ◽  
Author(s):  
Man Jin ◽  
Pingye Zhang

Adaptive seamless Phase 2-3 design has been considered as one possible way to expedite development time for a drug program by allowing the expansion from an ongoing Phase 2 trial into a Phase 3 trial. Multiple endpoints are often tested when a regulatory approval is pursued. Here we propose an adaptive seamless Phase 2-3 design with multiple endpoints which can expand an ongoing Phase 2 trial into a Phase 3 trial based on an intermediate endpoint for adaptive decision and test the endpoints with a powerful multiple test procedure. It is proved that the proposed design can preserve the familywise Type I error under a mild assumption that is expected to hold in practical considerations. We illustrate our proposed design with an example trial design for oncology. Simulations are conducted to confirm the control of the familywise Type I error and the adaptive seamless Phase 2-3 design is illustrated with an example.


Biometrics ◽  
1998 ◽  
Vol 54 (2) ◽  
pp. 673 ◽  
Author(s):  
Gerhard Hommel ◽  
Frank Krummenauer

1997 ◽  
Vol 38 (2) ◽  
pp. 210-213 ◽  
Author(s):  
T. Rand ◽  
B. Schneider ◽  
S. Grampp ◽  
P. Wunderbaldinger ◽  
H. Migsits ◽  
...  

Purpose: to quantify the relationship between individual osteophytic size and measured bone mineral density (BMD) of the lumbar spine by dual x-ray absorptiometry (DXA). Further, to evaluate the possible consequences of this relationship for the management of DXA measurements in postmenopausal patients. Material and Methods: in 142 postmenopausal women (mean age 61.8±8.9 years), plain radiographs of the lumbar spine were evaluated and graded according to evidence and size of osteophytes. the BMD (g/cm2) and Z-score (deviation of BMD from an age-matched population, %) of each vertebral body was determined by DXA. the effects of the individual osteophytic size on BMD measurements were analyzed by using analysis of variance followed by a multiple test procedure. Results: the presence of osteophytes resulted in a significant increase in BMD of L1 through L4. the increase in relation to an osteophytic size of about 10 mm was: in L1 5.7%, in L2 6.8%, in L3 4.4% and in L4 3.5%. Increases were significantly higher for an osteophytic size of 10–20 mm (L1 23.1%, L2 13.0%, L3 13.4%, and L4 16.3%) and of >20 mm (L1 21.4%, L2 22.4%, L3 21.1% and L4 4.1%). Conclusion: Our results indicate a nonlinear increase of measured BMD with increasing osteophytic size. These effects should be considered in routine examination and patient management.


2012 ◽  
Vol 51 (04) ◽  
pp. 309-317 ◽  
Author(s):  
M. Kieser ◽  
G. Rauch

SummaryBackground: Binary composite outcome measures are increasingly used as primary endpoints in clinical trials. Composite endpoints combine several events of interest within a single variable. However, as the effect observed for the composite does not necessarily reflect the effects for the individual components, it is recommended in the literature to additionally evaluate each component separately.Objectives: The task is to define an adequate multiple test procedure which focuses on the composite outcome measure but allows for a confirmatory interpretation of the components in case of large effects.Methods: In this paper, we determine the correlation matrix for a multiple binary endpoint problem of a composite endpoint and its components based on the normal approximation test statistic for rates. Thereby, we assume multinomial distributed components. We use this correlation to calculate the adjusted local significance levels. We discuss how to use our approach for a more informative formulation of the test problem. Our work is illustrated by two clinical trial examples.Results: By taking into account the special correlation structure between a binary composite outcome and its components, an adequate multiple test procedure to assess the composite and its components can be defined based on an approximate multivariate normal distribution without much loss in power compared to a test problem formulated exclusively for the composite.Conclusions: By incorporating the correlation under the null hypotheses, the global power for the multiple test problem assessing both the composite and its components can be increased as compared to simple Bonferroni-adjustment. Thus, a confirmatory analysis of the composite and its components might be possible without a large increase in sample size as compared to a single endpoint problem formulated exclusively for the composite


2014 ◽  
Vol 57 (1) ◽  
pp. 108-122 ◽  
Author(s):  
Irene Castro-Conde ◽  
Jacobo de Uña-Álvarez

1998 ◽  
Vol 26 (2) ◽  
pp. 353-363 ◽  
Author(s):  
Ajit C. Tamhane ◽  
Wei Liu ◽  
Charles W. Dunnett

Sign in / Sign up

Export Citation Format

Share Document