Abstract:
:The Food and Drug Administration of the United States issued a draft guidance on adaptive design clinical trials in February 2010. This draft guidance has attracted a lot of attention because of the increasing interest in adaptive trials by the pharmaceutical industry in recent years. In this paper, we report on highlights of comments collected within Pfizer on this draft guidance. In addition, we share Pfizer's internal journey to promote efficient trial designs since 2005. Adaptive designs have been part of that journey.
journal_name
J Biopharm Statjournal_title
Journal of biopharmaceutical statisticsauthors
Chuang-Stein C,Beltangady Mdoi
10.1080/10543406.2010.514456subject
Has Abstractpub_date
2010-11-01 00:00:00pages
1143-9issue
6eissn
1054-3406issn
1520-5711pii
929128025journal_volume
20pub_type
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