| On adaptive error spending approach for group sequential trials with random information levels. | |
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MedLine Citation:
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PMID: 22651109 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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A group sequential analysis following the error spending approach of Lan and DeMets ( 1983 ) requires that the maximum information level be fixed in advance. In practice, however, the maximum information level is often random, making it impossible to determine the information fractions required by Lan and DeMets ( 1983 ) to calculate the sequential boundary. We propose an adaptive error spending approach that further expands practical applications to settings where the interim information levels can depend on blinded accumulating data. We use a simple weighting method to combine independent test statistics from different stages, which are then compared with adaptive boundary values for the group sequential test. We develop a measure-theoretic framework and show that the adaptive error spending approach controls the type 1 error rates. Methods for point estimates and confidence intervals are also proposed. We warn that an error spending approach can lead to serious inflation of the type 1 error rates when the number or timing of interim analyses is allowed to depend on unblinded accumulating data. |
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Authors:
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Qing Liu; Pilar Lim; Issac Nuamah; Yulan Li |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Journal of biopharmaceutical statistics Volume: 22 ISSN: 1520-5711 ISO Abbreviation: J Biopharm Stat Publication Date: 2012 Jul |
Date Detail:
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Created Date: 2012-06-01 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9200436 Medline TA: J Biopharm Stat Country: England |
Other Details:
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Languages: eng Pagination: 687-99 Citation Subset: IM |
Affiliation:
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a Janssen Research and Development , LLC , Raritan , New Jersey , USA. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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