Abstract:
:A common question in clinical studies is how to use historical data from earlier studies, leveraging relevant information into the design and analysis of a new study. Bayesian approaches are particularly well-suited to this task, with their natural ability to borrow strength across data sources. In this paper, we propose an eMAP approach for incorporating historical data into the analysis of clinical studies, and we discuss an application of this method to the analysis of observational safety studies for a class of products for patients with hemophilia A. The eMAP prior approach is flexible and robust to prior-data conflict. We conducted simulations to compare the frequentist operating characteristics of three approaches under different prior-data conflict assumptions and sample size scenarios.
journal_name
J Biopharm Statjournal_title
Journal of biopharmaceutical statisticsauthors
Li JX,Chen WC,Scott JAdoi
10.1080/10543406.2016.1226324subject
Has Abstractpub_date
2016-01-01 00:00:00pages
1056-1066issue
6eissn
1054-3406issn
1520-5711journal_volume
26pub_type
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