Abstract:
:We propose an adaptive two-stage dose-response design where a prespecified adaptation rule is used to add and/or drop treatment arms between the stages. We extend the multiple comparison procedures-modeling (MCP-Mod) approach into a two-stage design. In each stage, we use the same set of candidate dose-response models and test for a dose-response relationship or proof of concept (PoC) via model-associated statistics. The stage-wise test results are then combined to establish "global" PoC using a conditional error function. Our simulation studies showed good and more robust power in our design method compared to conventional and fixed designs.
journal_name
J Biopharm Statjournal_title
Journal of biopharmaceutical statisticsauthors
Franchetti Y,Anderson SJ,Sampson ARdoi
10.1080/10543406.2013.813519subject
Has Abstractpub_date
2013-01-01 00:00:00pages
1124-54issue
5eissn
1054-3406issn
1520-5711journal_volume
23pub_type
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