Abstract:
:The sequential parallel comparison design (SPCD) is a two-stage design recommended for trials with possibly high placebo response. A drug-placebo comparison in the first stage is followed in the second stage by placebo nonresponders being re-randomized between drug and placebo. We describe how SPCD can be used in trials where multiple doses of a drug or multiple treatments are compared with placebo and present two adaptive approaches. We detail how to analyze data in such trials and give recommendations about the allocation proportion to placebo in the two stages of SPCD.
journal_name
J Biopharm Statjournal_title
Journal of biopharmaceutical statisticsauthors
Wang JJ,Ivanova Adoi
10.1080/10543406.2014.924960subject
Has Abstractpub_date
2014-01-01 00:00:00pages
1091-101issue
5eissn
1054-3406issn
1520-5711journal_volume
24pub_type
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