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Article: Self-designing trial combined with classical group sequential monitoring

TitleSelf-designing trial combined with classical group sequential monitoring
Authors
KeywordsAdaptive design
Clinical trial
Early termination
Group sequential method
Interim analysis
Issue Date2005
PublisherTaylor & Francis Inc. The Journal's web site is located at http://www.tandf.co.uk/journals/titles/10543406.asp
Citation
Journal Of Biopharmaceutical Statistics, 2005, v. 15 n. 4, p. 667-675 How to Cite?
AbstractAt the interim analyses of a clinical trial, it is appealing to modify the originally planned sample size in order to achieve an adequate power to detect a meaningful treatment effect. We propose a flexible sequential monitoring scheme through combining the self-designing and classical group sequential methods. The maximum sample size does not have to be specified in advance and one efficacy interim analysis is conducted for the purpose of possible early termination after the first block of data is observed. At the interim analysis for efficacy, the usual sufficient test statistic is used and the type I error rate is adjusted to maintain the overall nominal level. At the final analysis, the test is constructed from a weighted average of the blockwise test statistics based on the sequentially collected data. The weight function at each stage is determined by the observed data prior to that stage. The futility stopping rule allows the trial to be terminated when there is no beneficial treatment effect. We conduct simulation studies to evaluate the performance of the proposed design. Copyright © Taylor & Francis, Inc.
Persistent Identifierhttp://hdl.handle.net/10722/146566
ISSN
2015 Impact Factor: 0.882
2015 SCImago Journal Rankings: 0.850
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorYin, Gen_HK
dc.contributor.authorShen, Yen_HK
dc.date.accessioned2012-05-02T08:37:03Z-
dc.date.available2012-05-02T08:37:03Z-
dc.date.issued2005en_HK
dc.identifier.citationJournal Of Biopharmaceutical Statistics, 2005, v. 15 n. 4, p. 667-675en_HK
dc.identifier.issn1054-3406en_HK
dc.identifier.urihttp://hdl.handle.net/10722/146566-
dc.description.abstractAt the interim analyses of a clinical trial, it is appealing to modify the originally planned sample size in order to achieve an adequate power to detect a meaningful treatment effect. We propose a flexible sequential monitoring scheme through combining the self-designing and classical group sequential methods. The maximum sample size does not have to be specified in advance and one efficacy interim analysis is conducted for the purpose of possible early termination after the first block of data is observed. At the interim analysis for efficacy, the usual sufficient test statistic is used and the type I error rate is adjusted to maintain the overall nominal level. At the final analysis, the test is constructed from a weighted average of the blockwise test statistics based on the sequentially collected data. The weight function at each stage is determined by the observed data prior to that stage. The futility stopping rule allows the trial to be terminated when there is no beneficial treatment effect. We conduct simulation studies to evaluate the performance of the proposed design. Copyright © Taylor & Francis, Inc.en_HK
dc.languageengen_US
dc.publisherTaylor & Francis Inc. The Journal's web site is located at http://www.tandf.co.uk/journals/titles/10543406.aspen_HK
dc.relation.ispartofJournal of Biopharmaceutical Statisticsen_HK
dc.subjectAdaptive designen_HK
dc.subjectClinical trialen_HK
dc.subjectEarly terminationen_HK
dc.subjectGroup sequential methoden_HK
dc.subjectInterim analysisen_HK
dc.subject.meshAlgorithmsen_US
dc.subject.meshClinical Trials As Topic - Statistics & Numerical Dataen_US
dc.subject.meshData Interpretation, Statisticalen_US
dc.subject.meshResearch Designen_US
dc.subject.meshSample Sizeen_US
dc.titleSelf-designing trial combined with classical group sequential monitoringen_HK
dc.typeArticleen_HK
dc.identifier.emailYin, G: gyin@hku.hken_HK
dc.identifier.authorityYin, G=rp00831en_HK
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1081/BIP-200062850en_HK
dc.identifier.pmid16022171-
dc.identifier.scopuseid_2-s2.0-22044445098en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-22044445098&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume15en_HK
dc.identifier.issue4en_HK
dc.identifier.spage667en_HK
dc.identifier.epage675en_HK
dc.identifier.isiWOS:000236232700011-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridYin, G=8725807500en_HK
dc.identifier.scopusauthoridShen, Y=7404766770en_HK

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