Buchumschlag

Timing of the interim analysis in adaptive enrichment designs

With increasing interest in personalized medicine over the last years, study designs allowing to demonstrate efficacy in particular subgroups of the overall patient population become more important. Adaptive enrichment designs provide the possibility to both selecting the target population with the...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Hauptverfasser: Benner, Laura (VerfasserIn) , Kieser, Meinhard (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: 2018
In: Journal of biopharmaceutical statistics
Year: 2018, Jahrgang: 28, Heft: 4, Pages: 622-632
ISSN:1520-5711
DOI:10.1080/10543406.2017.1372769
Online-Zugang:Verlag, Volltext: http://dx.doi.org/10.1080/10543406.2017.1372769
Volltext
Verfasserangaben:Laura Benner, Meinhard Kieser

MARC

LEADER 00000caa a2200000 c 4500
001 1571948333
003 DE-627
005 20240529093501.0
007 cr uuu---uuuuu
008 180412s2018 xx |||||o 00| ||eng c
024 7 |a 10.1080/10543406.2017.1372769  |2 doi 
035 |a (DE-627)1571948333 
035 |a (DE-576)501948333 
035 |a (DE-599)BSZ501948333 
035 |a (OCoLC)1341002150 
040 |a DE-627  |b ger  |c DE-627  |e rda 
041 |a eng 
084 |a 33  |2 sdnb 
100 1 |a Benner, Laura  |d 1990-  |e VerfasserIn  |0 (DE-588)1155943597  |0 (DE-627)1018499296  |0 (DE-576)501946616  |4 aut 
245 1 0 |a Timing of the interim analysis in adaptive enrichment designs  |c Laura Benner, Meinhard Kieser 
264 1 |c 2018 
300 |a 11 
336 |a Text  |b txt  |2 rdacontent 
337 |a Computermedien  |b c  |2 rdamedia 
338 |a Online-Ressource  |b cr  |2 rdacarrier 
500 |a Published online: 30 Oct 2017 
500 |a Gesehen am 12.04.2018 
520 |a With increasing interest in personalized medicine over the last years, study designs allowing to demonstrate efficacy in particular subgroups of the overall patient population become more important. Adaptive enrichment designs provide the possibility to both selecting the target population with the most promising treatment benefit and testing for efficacy within a single trial. Here, the target population is selected in a prespecified interim analysis. So far, it has not been very well investigated how timing of the interim analysis should be chosen.We investigate the impact of the interim analysis timing on power for the situation of a normally distributed outcome considering two different classes of selection rules. The interim selection is based either on the estimated effect difference between subgroup and total population or on absolute effect estimates. In this article, we demonstrate that there are indeed scenarios in which the timing of the interim analysis has a large impact on power. However, no universally applicable timing with favorable performance exist since power depends on treatment effects, subgroup prevalence, and especially the applied selection rule. Instead, the operating characteristics should be investigated for the specific scenario at hand to determine the most appropriate timing. 
650 4 |a Adaptive designs 
650 4 |a enrichment designs 
650 4 |a interim analysis 
650 4 |a personalized medicine 
650 4 |a subgroup selection 
700 1 |a Kieser, Meinhard  |d 1960-  |e VerfasserIn  |0 (DE-588)103276547X  |0 (DE-627)739277766  |0 (DE-576)168963825  |4 aut 
773 0 8 |i Enthalten in  |t Journal of biopharmaceutical statistics  |d Philadelphia, PA : Taylor & Francis, 1991  |g 28(2018), 4, Seite 622-632  |h Online-Ressource  |w (DE-627)32047416X  |w (DE-600)2008925-9  |w (DE-576)27387828X  |x 1520-5711  |7 nnas  |a Timing of the interim analysis in adaptive enrichment designs 
773 1 8 |g volume:28  |g year:2018  |g number:4  |g pages:622-632  |g extent:11  |a Timing of the interim analysis in adaptive enrichment designs 
856 4 0 |u http://dx.doi.org/10.1080/10543406.2017.1372769  |x Verlag  |x Resolving-System  |3 Volltext 
951 |a AR 
992 |a 20180412 
993 |a Article 
994 |a 2018 
998 |g 103276547X  |a Kieser, Meinhard  |m 103276547X:Kieser, Meinhard  |d 910000  |d 999701  |e 910000PK103276547X  |e 999701PK103276547X  |k 0/910000/  |k 1/910000/999701/  |p 2  |y j 
998 |g 1155943597  |a Benner, Laura  |m 1155943597:Benner, Laura  |d 910000  |d 999701  |e 910000PB1155943597  |e 999701PB1155943597  |k 0/910000/  |k 1/910000/999701/  |p 1  |x j 
999 |a KXP-PPN1571948333  |e 3005941558 
BIB |a Y 
SER |a journal 
JSO |a {"id":{"doi":["10.1080/10543406.2017.1372769"],"eki":["1571948333"]},"relHost":[{"disp":"Timing of the interim analysis in adaptive enrichment designsJournal of biopharmaceutical statistics","language":["eng"],"part":{"issue":"4","text":"28(2018), 4, Seite 622-632","pages":"622-632","year":"2018","volume":"28","extent":"11"},"type":{"bibl":"periodical","media":"Online-Ressource"},"note":["Gesehen am 28.11.11"],"origin":[{"publisher":"Taylor & Francis ; Dekker","dateIssuedKey":"1991","publisherPlace":"Philadelphia, PA ; New York, NY","dateIssuedDisp":"1991-"}],"titleAlt":[{"title":"JBS"}],"title":[{"title":"Journal of biopharmaceutical statistics","title_sort":"Journal of biopharmaceutical statistics","subtitle":"JBS"}],"recId":"32047416X","pubHistory":["1.1991 -"],"physDesc":[{"extent":"Online-Ressource"}],"id":{"zdb":["2008925-9"],"issn":["1520-5711"],"eki":["32047416X"]}}],"recId":"1571948333","physDesc":[{"extent":"11 S."}],"name":{"displayForm":["Laura Benner, Meinhard Kieser"]},"language":["eng"],"origin":[{"dateIssuedKey":"2018","dateIssuedDisp":"2018"}],"note":["Published online: 30 Oct 2017","Gesehen am 12.04.2018"],"type":{"media":"Online-Ressource","bibl":"article-journal"},"title":[{"title":"Timing of the interim analysis in adaptive enrichment designs","title_sort":"Timing of the interim analysis in adaptive enrichment designs"}],"person":[{"display":"Benner, Laura","family":"Benner","role":"aut","given":"Laura"},{"given":"Meinhard","role":"aut","family":"Kieser","display":"Kieser, Meinhard"}]} 
SRT |a BENNERLAURTIMINGOFTH2018 

Ähnliche Einträge