A hybrid Bayesian-frequentist approach to evaluate clinical trial designs for tests of superiority and non-inferiority

2007 ◽  
Vol 27 (4) ◽  
pp. 504-519 ◽  
Author(s):  
Yongzhao Shao ◽  
Vandana Mukhi ◽  
Judith D. Goldberg
Keyword(s):  
Clinical Trial ◽  
Frequentist Approach ◽  
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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