Decision Theoretic Designs for Phase II Clinical Trials with Multiple Outcomes
Identifieur interne : 002104 ( Main/Merge ); précédent : 002103; suivant : 002105Decision Theoretic Designs for Phase II Clinical Trials with Multiple Outcomes
Auteurs : Nigel Stallard [Royaume-Uni] ; Peter F. Thall [États-Unis] ; John Whitehead [Royaume-Uni]Source :
- Biometrics [ 0006-341X ] ; 1999-09.
English descriptors
- KwdEn :
Abstract
Summary. In many phase II clinical trials, it is essential to assess both efficacy and safety. Although several phase II designs that accommodate multiple outcomes have been proposed recently, none are derived using decision theory. This paper describes a Bayesian decision theoretic strategy for constructing phase II designs based on both efficacy and adverse events. The gain function includes utilities assigned to patient outcomes, a reward for declaring the new treatment promising, and costs associated with the conduct of the phase II trial and future phase III testing. A method for eliciting gain function parameters from medical collaborators and for evaluating the design's frequentist operating characteristics is described. The strategy is illustrated by application to a clinical trial of peripheral blood stem cell transplantation for multiple myeloma.
Url:
DOI: 10.1111/j.0006-341X.1999.00971.x
Links toward previous steps (curation, corpus...)
- to stream Istex, to step Corpus: 002926
- to stream Istex, to step Curation: 002726
- to stream Istex, to step Checkpoint: 001546
Links to Exploration step
ISTEX:0441E4A95F1238196AE17D9BB1A0CF81FD6F29CALe document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Decision Theoretic Designs for Phase II Clinical Trials with Multiple Outcomes</title><author><name sortKey="Stallard, Nigel" sort="Stallard, Nigel" uniqKey="Stallard N" first="Nigel" last="Stallard">Nigel Stallard</name></author><author><name sortKey="Thall, Peter F" sort="Thall, Peter F" uniqKey="Thall P" first="Peter F." last="Thall">Peter F. Thall</name></author><author><name sortKey="Whitehead, John" sort="Whitehead, John" uniqKey="Whitehead J" first="John" last="Whitehead">John Whitehead</name></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:0441E4A95F1238196AE17D9BB1A0CF81FD6F29CA</idno><date when="1999" year="1999">1999</date><idno type="doi">10.1111/j.0006-341X.1999.00971.x</idno><idno type="url">https://api.istex.fr/document/0441E4A95F1238196AE17D9BB1A0CF81FD6F29CA/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">002926</idno><idno type="wicri:Area/Istex/Curation">002726</idno><idno type="wicri:Area/Istex/Checkpoint">001546</idno><idno type="wicri:doubleKey">0006-341X:1999:Stallard N:decision:theoretic:designs</idno><idno type="wicri:Area/Main/Merge">002104</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Decision Theoretic Designs for Phase II Clinical Trials with Multiple Outcomes</title><author><name sortKey="Stallard, Nigel" sort="Stallard, Nigel" uniqKey="Stallard N" first="Nigel" last="Stallard">Nigel Stallard</name><affiliation wicri:level="1"><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Medical and Pharmaceutical Statistics Research Unit, The University of Reading, P.O. Box 240, Earley Gate, Reading RG6 6FN</wicri:regionArea><wicri:noRegion>Reading RG6 6FN</wicri:noRegion></affiliation></author><author><name sortKey="Thall, Peter F" sort="Thall, Peter F" uniqKey="Thall P" first="Peter F." last="Thall">Peter F. Thall</name><affiliation wicri:level="1"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Biostatistics, M. D. Anderson Cancer Center, University of Texas, Box 237, 1515 Holcombe Boulevard, Houston, Texas 77030</wicri:regionArea><wicri:noRegion>Texas 77030</wicri:noRegion></affiliation></author><author><name sortKey="Whitehead, John" sort="Whitehead, John" uniqKey="Whitehead J" first="John" last="Whitehead">John Whitehead</name><affiliation wicri:level="1"><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Medical and Pharmaceutical Statistics Research Unit, The University of Reading, P.O. Box 240, Earley Gate, Reading RG6 6FN</wicri:regionArea><wicri:noRegion>Reading RG6 6FN</wicri:noRegion></affiliation></author></analytic><monogr></monogr><series><title level="j">Biometrics</title><idno type="ISSN">0006-341X</idno><idno type="eISSN">1541-0420</idno><imprint><publisher>Blackwell Publishing Ltd</publisher><pubPlace>Oxford, UK</pubPlace><date type="published" when="1999-09">1999-09</date><biblScope unit="volume">55</biblScope><biblScope unit="issue">3</biblScope><biblScope unit="page" from="971">971</biblScope><biblScope unit="page" to="977">977</biblScope></imprint><idno type="ISSN">0006-341X</idno></series><idno type="istex">0441E4A95F1238196AE17D9BB1A0CF81FD6F29CA</idno><idno type="DOI">10.1111/j.0006-341X.1999.00971.x</idno><idno type="ArticleID">BIOM971</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0006-341X</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Backward induction</term><term>Clinical trial design</term><term>Optimal stopping</term><term>Safety and efficacy monitoring</term><term>Sequential procedure</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Summary. In many phase II clinical trials, it is essential to assess both efficacy and safety. Although several phase II designs that accommodate multiple outcomes have been proposed recently, none are derived using decision theory. This paper describes a Bayesian decision theoretic strategy for constructing phase II designs based on both efficacy and adverse events. The gain function includes utilities assigned to patient outcomes, a reward for declaring the new treatment promising, and costs associated with the conduct of the phase II trial and future phase III testing. A method for eliciting gain function parameters from medical collaborators and for evaluating the design's frequentist operating characteristics is described. The strategy is illustrated by application to a clinical trial of peripheral blood stem cell transplantation for multiple myeloma.</div></front></TEI></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Ticri/CIDE/explor/OcrV1/Data/Main/Merge
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 002104 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Merge/biblio.hfd -nk 002104 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Ticri/CIDE
|area= OcrV1
|flux= Main
|étape= Merge
|type= RBID
|clé= ISTEX:0441E4A95F1238196AE17D9BB1A0CF81FD6F29CA
|texte= Decision Theoretic Designs for Phase II Clinical Trials with Multiple Outcomes
}}
| This area was generated with Dilib version V0.6.32. |  |