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Article: Bayesian phase II adaptive randomization by jointly modeling time-to-event efficacy and binary toxicity

TitleBayesian phase II adaptive randomization by jointly modeling time-to-event efficacy and binary toxicity
Authors
KeywordsAdaptive randomization
Efficacy
Phase II trial
Survival analysis
Time-to-event endpoint
Toxicity
Issue Date2011
PublisherSpringer Verlag Dordrecht. The Journal's web site is located at http://springerlink.metapress.com/openurl.asp?genre=journal&issn=1380-7870
Citation
Lifetime Data Analysis, 2011, v. 17 n. 1, p. 156-174 How to Cite?
AbstractIn oncology, toxicity is typically observable shortly after a chemotherapy treatment, whereas efficacy, often characterized by tumor shrinkage, is observable after a relatively long period of time. In a phase II clinical trial design, we propose a Bayesian adaptive randomization procedure that accounts for both efficacy and toxicity outcomes. We model efficacy as a time-to-event endpoint and toxicity as a binary endpoint, sharing common random effects in order to induce dependence between the bivariate outcomes. More generally, we allow the randomization probability to depend on patients' specific covariates, such as prognostic factors. Early stopping boundaries are constructed for toxicity and futility, and a superior treatment arm is recommended at the end of the trial. Following the setup of a recent renal cancer clinical trial at M. D. Anderson Cancer Center, we conduct extensive simulation studies under various scenarios to investigate the performance of the proposed method, and compare it with available Bayesian adaptive randomization procedures. © 2010 Springer Science+Business Media, LLC.
Persistent Identifierhttp://hdl.handle.net/10722/125407
ISSN
2015 Impact Factor: 0.81
2015 SCImago Journal Rankings: 0.717
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorLei, Xen_HK
dc.contributor.authorYuan, Yen_HK
dc.contributor.authorYin, Gen_HK
dc.date.accessioned2010-10-31T11:29:39Z-
dc.date.available2010-10-31T11:29:39Z-
dc.date.issued2011en_HK
dc.identifier.citationLifetime Data Analysis, 2011, v. 17 n. 1, p. 156-174en_HK
dc.identifier.issn1380-7870en_HK
dc.identifier.urihttp://hdl.handle.net/10722/125407-
dc.description.abstractIn oncology, toxicity is typically observable shortly after a chemotherapy treatment, whereas efficacy, often characterized by tumor shrinkage, is observable after a relatively long period of time. In a phase II clinical trial design, we propose a Bayesian adaptive randomization procedure that accounts for both efficacy and toxicity outcomes. We model efficacy as a time-to-event endpoint and toxicity as a binary endpoint, sharing common random effects in order to induce dependence between the bivariate outcomes. More generally, we allow the randomization probability to depend on patients' specific covariates, such as prognostic factors. Early stopping boundaries are constructed for toxicity and futility, and a superior treatment arm is recommended at the end of the trial. Following the setup of a recent renal cancer clinical trial at M. D. Anderson Cancer Center, we conduct extensive simulation studies under various scenarios to investigate the performance of the proposed method, and compare it with available Bayesian adaptive randomization procedures. © 2010 Springer Science+Business Media, LLC.en_HK
dc.languageengen_HK
dc.publisherSpringer Verlag Dordrecht. The Journal's web site is located at http://springerlink.metapress.com/openurl.asp?genre=journal&issn=1380-7870en_HK
dc.relation.ispartofLifetime Data Analysisen_HK
dc.rightsThe original publication is available at www.springerlink.com-
dc.subjectAdaptive randomizationen_HK
dc.subjectEfficacyen_HK
dc.subjectPhase II trialen_HK
dc.subjectSurvival analysisen_HK
dc.subjectTime-to-event endpointen_HK
dc.subjectToxicityen_HK
dc.titleBayesian phase II adaptive randomization by jointly modeling time-to-event efficacy and binary toxicityen_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=1380-7870&volume=17&issue=1&spage=156&epage=174&date=2010&atitle=Bayesian+phase+II+adaptive+randomization+by+jointly+modeling+time-to-event+efficacy+and+binary+toxicityen_HK
dc.identifier.emailYin, G: gyin@hku.hken_HK
dc.identifier.authorityYin, G=rp00831en_HK
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1007/s10985-010-9163-zen_HK
dc.identifier.pmid20364321-
dc.identifier.scopuseid_2-s2.0-78651428711en_HK
dc.identifier.hkuros195649en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-78651428711&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume17en_HK
dc.identifier.issue1en_HK
dc.identifier.spage156en_HK
dc.identifier.epage174en_HK
dc.identifier.isiWOS:000286202400014-
dc.publisher.placeNetherlandsen_HK
dc.identifier.scopusauthoridLei, X=9336235800en_HK
dc.identifier.scopusauthoridYuan, Y=7402709174en_HK
dc.identifier.scopusauthoridYin, G=8725807500en_HK
dc.identifier.citeulike6981624-

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