Computations for Group Sequential Boundaries Using the Lan-DeMets Spending Function Method
Identifieur interne : 009D60 ( Main/Exploration ); précédent : 009D59; suivant : 009D61Computations for Group Sequential Boundaries Using the Lan-DeMets Spending Function Method
Auteurs : David M. Reboussin [États-Unis] ; David L. Demets [États-Unis] ; Kyungmann Kim [États-Unis] ; K. K. Gordon Lan [États-Unis]Source :
- Controlled Clinical Trials [ 0197-2456 ] ; 2000.
English descriptors
- Teeft :
- Alpha spending function, Alternative hypothesis, Analysis times, Boundary values, Brownian motion, Brownian motion drift parameter, Calendar time, Calendar times, Cardiac arrhythmia suppression trial, Clinical trial, Clinical trials, Computation, Control group, Control groups, Demets, Design purposes, Drift parameter, Exit probabilities, Grid, Grid point, Grid size, Group sequential, Group sequential boundaries, Group sequential boundaries table, Group sequential logrank tests, Group sequential methods, Group sequential testing, Group sequential tests, Hazard function, Independent increments, Information fraction, Information fractions, Information time, Information times, Interim analyses, Interim analysis, June, Maximum duration, Maximum information, Maximum number, Measures example, Null hypothesis, Numerical integration, October, Output boundary values, Overall level, Power computations, Previous example, Reboussin, Sample size, Second timescale, Sequential, Sequential boundaries, Sequential monitoring, Sequential plan, Sequential test statistics, Spending function, Spending functions, Standardized statistic, Stat assoc, Statistic, Technical report, Test statistic, Test statistics, Total number, Total sample size, Treatment effect, Treatment group, Treatment groups, Type boundaries, Variance, Variance parameters, Wide variety.
Abstract
Abstract: We describe an interactive Fortran program which performs computations related to the design and analysis of group sequential clinical trials using Lan-DeMets spending functions. Many clinical trials include interim analyses of accumulating data and rely on group sequential methods to avoid consequent inflation of the type I error rate. The computations are appropriate for interim test statistics whose distribution or limiting distribution is multivariate normal with independent increments. Recent theoretical results indicate that virtually any design likely to be used in a clinical trial will fall into this category. Interim analyses need not be equally spaced, and their number need not be specified in advance. In addition to determining sequential boundaries using an alpha spending function, the program can perform power computations, compute probabilities associated with a given set of boundaries, and generate confidence intervals. Control Clin Trials 2000;21:190–207
Url:
DOI: 10.1016/S0197-2456(00)00057-X
Affiliations:
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Reboussin</name><affiliation wicri:level="2"><country>États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem</wicri:cityArea></affiliation></author><author><name sortKey="Demets, David L" sort="Demets, David L" uniqKey="Demets D" first="David L." last="Demets">David L. Demets</name><affiliation wicri:level="2"><country>États-Unis</country><placeName><region type="state">Wisconsin</region></placeName><wicri:cityArea>Department of Biostatistics, University of Wisconsin Medical School, Madison</wicri:cityArea></affiliation></author><author><name sortKey="Kim, Kyungmann" sort="Kim, Kyungmann" uniqKey="Kim K" first="Kyungmann" last="Kim">Kyungmann Kim</name><affiliation wicri:level="2"><country>États-Unis</country><placeName><region type="state">Wisconsin</region></placeName><wicri:cityArea>Department of Biostatistics, University of Wisconsin Medical School, Madison</wicri:cityArea></affiliation></author><author><name sortKey="Lan, K K Gordon" sort="Lan, K K Gordon" uniqKey="Lan K" first="K. K. Gordon" last="Lan">K. K. Gordon Lan</name><affiliation wicri:level="2"><country>États-Unis</country><placeName><region type="state">Connecticut</region></placeName><wicri:cityArea>Clinical Research Division, Pfizer Incorporated, Groton</wicri:cityArea></affiliation></author></analytic><monogr></monogr><series><title level="j">Controlled Clinical Trials</title><title level="j" type="abbrev">CCT</title><idno type="ISSN">0197-2456</idno><imprint><publisher>ELSEVIER</publisher><date type="published" when="2000">2000</date><biblScope unit="volume">21</biblScope><biblScope unit="issue">3</biblScope><biblScope unit="page" from="190">190</biblScope><biblScope unit="page" to="207">207</biblScope></imprint><idno type="ISSN">0197-2456</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0197-2456</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="Teeft" xml:lang="en"><term>Alpha spending function</term><term>Alternative hypothesis</term><term>Analysis times</term><term>Boundary values</term><term>Brownian motion</term><term>Brownian motion drift parameter</term><term>Calendar time</term><term>Calendar times</term><term>Cardiac arrhythmia suppression trial</term><term>Clinical trial</term><term>Clinical trials</term><term>Computation</term><term>Control group</term><term>Control groups</term><term>Demets</term><term>Design purposes</term><term>Drift parameter</term><term>Exit probabilities</term><term>Grid</term><term>Grid point</term><term>Grid size</term><term>Group sequential</term><term>Group sequential boundaries</term><term>Group sequential boundaries table</term><term>Group sequential logrank tests</term><term>Group sequential methods</term><term>Group sequential testing</term><term>Group sequential tests</term><term>Hazard function</term><term>Independent increments</term><term>Information fraction</term><term>Information fractions</term><term>Information time</term><term>Information times</term><term>Interim analyses</term><term>Interim analysis</term><term>June</term><term>Maximum duration</term><term>Maximum information</term><term>Maximum number</term><term>Measures example</term><term>Null hypothesis</term><term>Numerical integration</term><term>October</term><term>Output boundary values</term><term>Overall level</term><term>Power computations</term><term>Previous example</term><term>Reboussin</term><term>Sample size</term><term>Second timescale</term><term>Sequential</term><term>Sequential boundaries</term><term>Sequential monitoring</term><term>Sequential plan</term><term>Sequential test statistics</term><term>Spending function</term><term>Spending functions</term><term>Standardized statistic</term><term>Stat assoc</term><term>Statistic</term><term>Technical report</term><term>Test statistic</term><term>Test statistics</term><term>Total number</term><term>Total sample size</term><term>Treatment effect</term><term>Treatment group</term><term>Treatment groups</term><term>Type boundaries</term><term>Variance</term><term>Variance parameters</term><term>Wide variety</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Abstract: We describe an interactive Fortran program which performs computations related to the design and analysis of group sequential clinical trials using Lan-DeMets spending functions. Many clinical trials include interim analyses of accumulating data and rely on group sequential methods to avoid consequent inflation of the type I error rate. The computations are appropriate for interim test statistics whose distribution or limiting distribution is multivariate normal with independent increments. Recent theoretical results indicate that virtually any design likely to be used in a clinical trial will fall into this category. Interim analyses need not be equally spaced, and their number need not be specified in advance. In addition to determining sequential boundaries using an alpha spending function, the program can perform power computations, compute probabilities associated with a given set of boundaries, and generate confidence intervals. Control Clin Trials 2000;21:190–207</div></front></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>Caroline du Nord</li><li>Connecticut</li><li>Wisconsin</li></region></list><tree><country name="États-Unis"><region name="Caroline du Nord"><name sortKey="Reboussin, David M" sort="Reboussin, David M" uniqKey="Reboussin D" first="David M." last="Reboussin">David M. Reboussin</name></region><name sortKey="Demets, David L" sort="Demets, David L" uniqKey="Demets D" first="David L." last="Demets">David L. Demets</name><name sortKey="Kim, Kyungmann" sort="Kim, Kyungmann" uniqKey="Kim K" first="Kyungmann" last="Kim">Kyungmann Kim</name><name sortKey="Lan, K K Gordon" sort="Lan, K K Gordon" uniqKey="Lan K" first="K. K. Gordon" last="Lan">K. K. Gordon Lan</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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