Recent Publication: A Gatekeeping Procedure to Test a Primary and a Secondary Endpoint in a Group Sequential Design with Multiple Interim Looks

Posted by Cytel

Feb 15, 2018 10:35:00 AM

A recent publication in Biometrics ‘A Gatekeeping Procedure to Test a Primary and a Secondary Endpoint in a Group Sequential Design with Multiple Interim Looks’ greatly extends the results of Glimm et al. ( 2010) and Tamhane et al ( 2010) which studied the problem of testing a primary and secondary endpoint, subject to a gatekeeping constraint, using a group sequential design (GSD) with K = 2...

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Topics: Statistical Analysis, biostatistics, adaptive trials, Group Sequential, Cyrus Mehta


Adaptive Designs in Practice

Posted by Cytel

Apr 28, 2016 12:30:00 PM

Adaptive Designs in Practice: Interview with NIHR Research Fellow Munya Dimairo

NIHR and University of Sheffield researchers recently published a paper, ‘Adaptive designs undertaken in clinical research: a review of registered clinical trials’(Hatfield et al) which explores the current state of adaptive designs in practice. In this blog we catch up with Munya Dimairo, NIHR Research fellow and...

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Topics: Group Sequential, Adaptive Clinical Trials, adaptive sample size re-estimation, adaptive designs, adaptive trials


Clinical Development & Statistical Methodology for Cardiovascular Risk Assessment

Posted by Cytel

Feb 3, 2015 2:00:00 PM

A new publication co-authored by Cytel Co-Founder and President Cyrus Mehta considers a range of clinical development methods for cardiovascular outcome trials. Cardiovascular outcome trials, (often referred to as CVOTs), reflect safety standards implemented by the FDA and EMA to determine whether or not new drugs impose undue cardiovascular risk on patients. CVOTs typically occur after Phase 3...

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Topics: Cardiovascular, Group Sequential, Adaptive Clinical Trials


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