Linked Life Data

19206095

Source:http://linkedlifedata.com/resource/pubmed/id/19206095

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
8
pubmed:dateCreated
2009-3-19
pubmed:abstractText
Adaptive designs play an increasingly important role in clinical drug development. Such designs use accumulating data of an ongoing trial to decide how to modify design aspects without undermining the validity and integrity of the trial. Adaptive designs thus allow for a number of possible adaptations at midterm: Early stopping either for futility or success, sample size reassessment, change of population, etc. A particularly appealing application is the use of adaptive designs in combined phase II/III studies with treatment selection at interim. The expectation has arisen that carefully planned and conducted studies based on adaptive designs increase the efficiency of the drug development process by making better use of the observed data, thus leading to a higher information value per patient.In this paper we focus on adaptive designs for confirmatory clinical trials. We review the adaptive design methodology for a single null hypothesis and how to perform adaptive designs with multiple hypotheses using closed test procedures. We report the results of an extensive simulation study to evaluate the operational characteristics of the various methods. A case study and related numerical examples are used to illustrate the key results. In addition we provide a detailed discussion of current methods to calculate point estimates and confidence intervals for relevant parameters.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Apr
pubmed:issn
0277-6715
pubmed:author
pubmed:issnType
Print
pubmed:day
15
pubmed:volume
28
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
1181-217
pubmed:meshHeading
pubmed:year
2009
pubmed:articleTitle
Adaptive designs for confirmatory clinical trials.
pubmed:affiliation
Novartis Pharma AG, Lichtstrasse 35, 4002 Basel, Switzerland. franz.koeing@meduniwien.ac.at
pubmed:publicationType
Journal Article, Research Support, Non-U.S. Gov't