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Article: Worth adapting? Revisiting the usefulness of outcome-adaptive randomization

TitleWorth adapting? Revisiting the usefulness of outcome-adaptive randomization
Authors
Issue Date2012
PublisherAmerican Association for Cancer Research. The Journal's web site is located at http://clincancerres.aacrjournals.org/
Citation
Clinical Cancer Research, 2012, v. 18 n. 17, p. 4498-4507 How to Cite?
AbstractOutcome-adaptive randomization allocates more patients to the better treatments as the information accumulates in the trial. Is it worth it to apply outcome-adaptive randomization in clinical trials? Different views permeate the medical and statistical communities. We provide additional insights to the question by conducting extensive simulation studies. Trials are designed to maintain the type I error rate, achieve a specified power, and provide better treatment to patients. Generally speaking, equal randomization requires a smaller sample size and yields a smaller number of nonresponders than adaptive randomization by controlling type I and type II errors. Conversely, adaptive randomization produces a higher overall response rate than equal randomization with or without expanding the trial to the same maximum sample size. When there are substantial treatment differences, adaptive randomization can yield a higher overall response rate as well as a lower average sample size and a smaller number of nonresponders. Similar results are found for the survival endpoint. The differences between adaptive randomization and equal randomization quickly diminish with early stopping of a trial due to efficacy or futility. In summary, equal randomization maintains balanced allocation throughout the trial and reaches the specified statistical power with a smaller number of patients in the trial. If the trial's results are positive, equal randomization may lead to early approval of the treatment. Adaptive randomization focuses on treating patients best in the trial. Adaptive randomization may be preferred when the difference in efficacy between treatments is large or when the number of patients available is limited. ©2012 AACR.
Persistent Identifierhttp://hdl.handle.net/10722/172509
ISSN
2015 Impact Factor: 8.738
2015 SCImago Journal Rankings: 5.314
PubMed Central ID
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorLee, JJen_US
dc.contributor.authorChen, Nen_US
dc.contributor.authorYin, Gen_US
dc.date.accessioned2012-10-30T06:22:51Z-
dc.date.available2012-10-30T06:22:51Z-
dc.date.issued2012en_US
dc.identifier.citationClinical Cancer Research, 2012, v. 18 n. 17, p. 4498-4507en_US
dc.identifier.issn1078-0432en_US
dc.identifier.urihttp://hdl.handle.net/10722/172509-
dc.description.abstractOutcome-adaptive randomization allocates more patients to the better treatments as the information accumulates in the trial. Is it worth it to apply outcome-adaptive randomization in clinical trials? Different views permeate the medical and statistical communities. We provide additional insights to the question by conducting extensive simulation studies. Trials are designed to maintain the type I error rate, achieve a specified power, and provide better treatment to patients. Generally speaking, equal randomization requires a smaller sample size and yields a smaller number of nonresponders than adaptive randomization by controlling type I and type II errors. Conversely, adaptive randomization produces a higher overall response rate than equal randomization with or without expanding the trial to the same maximum sample size. When there are substantial treatment differences, adaptive randomization can yield a higher overall response rate as well as a lower average sample size and a smaller number of nonresponders. Similar results are found for the survival endpoint. The differences between adaptive randomization and equal randomization quickly diminish with early stopping of a trial due to efficacy or futility. In summary, equal randomization maintains balanced allocation throughout the trial and reaches the specified statistical power with a smaller number of patients in the trial. If the trial's results are positive, equal randomization may lead to early approval of the treatment. Adaptive randomization focuses on treating patients best in the trial. Adaptive randomization may be preferred when the difference in efficacy between treatments is large or when the number of patients available is limited. ©2012 AACR.en_US
dc.languageengen_US
dc.publisherAmerican Association for Cancer Research. The Journal's web site is located at http://clincancerres.aacrjournals.org/-
dc.relation.ispartofClinical Cancer Researchen_US
dc.titleWorth adapting? Revisiting the usefulness of outcome-adaptive randomizationen_US
dc.typeArticleen_US
dc.identifier.emailYin, G: gyin@hku.hken_US
dc.identifier.authorityYin, G=rp00831en_US
dc.description.naturelink_to_OA_fulltexten_US
dc.identifier.doi10.1158/1078-0432.CCR-11-2555en_US
dc.identifier.pmid22753588-
dc.identifier.pmcidPMC3495976-
dc.identifier.scopuseid_2-s2.0-84865740846en_US
dc.identifier.hkuros223929-
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-84865740846&selection=ref&src=s&origin=recordpageen_US
dc.identifier.volume18en_US
dc.identifier.issue17en_US
dc.identifier.spage4498en_US
dc.identifier.epage4507en_US
dc.identifier.isiWOS:000309964500005-
dc.publisher.placeUnited Statesen_US
dc.identifier.scopusauthoridLee, JJ=7601452666en_US
dc.identifier.scopusauthoridChen, N=54882570100en_US
dc.identifier.scopusauthoridYin, G=8725807500en_US

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