scholarly journals Bayesian evaluation of group sequential clinical trial designs

2007 ◽  
Vol 26 (7) ◽  
pp. 1431-1449 ◽  
Author(s):  
Scott S. Emerson ◽  
John M. Kittelson ◽  
Daniel L. Gillen
Keyword(s):  
Clinical Trial ◽  
Group Sequential ◽  
Clinical Trial Designs

scholarly journals Group-sequential three-arm noninferiority clinical trial designs

2016 ◽  
Vol 27 (1) ◽  
pp. 1-24 ◽  
Author(s):  
Toshimitsu Ochiai ◽  
Toshimitsu Hamasaki ◽  
Scott R. Evans ◽  
Koko Asakura ◽  
Yuko Ohno
Keyword(s):  
Clinical Trial ◽  
Group Sequential ◽  
Clinical Trial Designs

scholarly journals Group Sequential Clinical Trial Designs for Normally Distributed Outcome Variables

2018 ◽  
Vol 18 (2) ◽  
pp. 416-431
Author(s):  
Michael J. Grayling ◽  
James M. S. Wason ◽  
Adrian P. Mander
Keyword(s):  
Clinical Trial ◽  
Classical Group ◽  
Economic Benefits ◽  
Outcome Variable ◽  
Sequential Designs ◽  
Group Sequential ◽  
Time Points ◽  
Clinical Trial Designs ◽  
Numerous Time ◽  
Normally Distributed

In a group sequential clinical trial, accumulated data are analyzed at numerous time points to allow early decisions about a hypothesis of interest. These designs have historically been recommended for their ethical, administrative, and economic benefits. In this article, we first discuss a collection of new commands for computing the stopping boundaries and required group size of various classical group sequential designs, assuming a normally distributed outcome variable. Then, we demonstrate how the performance of several designs can be compared graphically.

scholarly journals Frequentist evaluation of group sequential clinical trial designs

2007 ◽  
Vol 26 (28) ◽  
pp. 5047-5080 ◽  
Author(s):  
Scott S. Emerson ◽  
John M. Kittelson ◽  
Daniel L. Gillen
Keyword(s):  
Clinical Trial ◽  
Group Sequential ◽  
Clinical Trial Designs

scholarly journals New clinical trial designs for HIV vaccine evaluation

2013 ◽  
Vol 8 (5) ◽  
pp. 437-442 ◽  
Author(s):  
Zoe Moodie ◽  
Holly Janes ◽  
Yunda Huang
Keyword(s):  
Clinical Trial ◽  
Hiv Vaccine ◽  
Clinical Trial Designs

Current Advances in Clinical Trials for Rare Disease Populations: Spotlight on the Patient

2021 ◽  
Vol 16 ◽  
Author(s):  
Erica Winter ◽  
Scott Schliebner
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Drug Development ◽  
Rare Disease ◽  
Rare Diseases ◽  
Statistical Analyses ◽  
Clinical Trial Designs ◽  
Novel Approaches

: Characterized by small, highly heterogeneous patient populations, rare disease trials magnify the challenges often encountered in traditional clinical trials. In recent years, there have been increased efforts by stakeholders to improve drug development in rare diseases through novel approaches to clinical trial designs and statistical analyses. We highlight and discuss some of the current and emerging approaches aimed at overcoming challenges in rare disease clinical trials, with a focus on the ultimate stakeholder, the patient.

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