Abstract:
:When performing a pivotal clinical trial, it may be of interest to assess the probability of success (PoS) of that trial. Initially evaluated when the trial is designed, PoS can be updated as the trial progresses and new information about the drug effect becomes available. Such information can be external to the trial, such as results from trials conducted in parallel, or internal, such as continuing after an interim analysis. We develop a framework to update PoS based on such internal and external information for a time-to-event endpoint and illustrate it using a realistic development program for a new molecule.
journal_name
J Biopharm Statjournal_title
Journal of biopharmaceutical statisticsauthors
Rufibach K,Jordan P,Abt Mdoi
10.1080/10543406.2014.972508subject
Has Abstractpub_date
2016-01-01 00:00:00pages
191-201issue
2eissn
1054-3406issn
1520-5711journal_volume
26pub_type
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