Linked Life Data

18027224

Source:http://linkedlifedata.com/resource/pubmed/id/18027224

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
6
pubmed:dateCreated
2007-11-20
pubmed:abstractText
In clinical trials, multiple doses of a new drug are often tested in a Phase II dose finding study. A promising dose then is chosen for further testing and confirmation of its effectiveness in a Phase III study. Although this approach is pragmatically sound, it is known to be inefficient and unreliable because of the time and resource spent on and the very limited information generated from the Phase II study. In this research, a seamless design based on adaptive patient allocation is proposed to combine the traditional Phase II and Phase III steps to achieve the objectives of dose identification and confirmation at the same time within one study. The control of type I error rate is discussed and simulations show that with the proposed method the type I error rate of the study is controlled, and its efficiency and reliability are greatly improved as compared to the traditional approach.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:status
MEDLINE
pubmed:issn
1054-3406
pubmed:author
pubmed:issnType
Print
pubmed:volume
17
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
1177-87
pubmed:meshHeading
pubmed:year
2007
pubmed:articleTitle
Seamless Phase II/III combination study through response adaptive randomization.
pubmed:affiliation
Biostatistics and Programming, Sanofi Aventis, Bridgewater, New Jersey 08807, USA. lin.wang2@sanofi-aventis.com
pubmed:publicationType
Journal Article