Adaptive designs for two candidate primary time-to-event endpoints
In clinical trials, the choice of an adequate primary endpoint is often difficult. Besides its clinical relevance, the endpoint must be measurable within reasonable time and must allow differentiating between the treatments. Often, the most relevant endpoint is ‘’time-to-death,” but if the overall s...
Gespeichert in:
| Hauptverfasser: | , , , , |
|---|---|
| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
02 Jun 2016
|
| In: |
Statistics in biopharmaceutical research
Year: 2016, Jahrgang: 8, Heft: 2, Pages: 207-216 |
| ISSN: | 1946-6315 |
| DOI: | 10.1080/19466315.2016.1143391 |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1080/19466315.2016.1143391
|
| Verfasserangaben: | Geraldine Rauch, Svenja Schüler, Marius Wirths, Stefan Englert, and Meinhard Kieser |
MARC
| LEADER | 00000caa a2200000 c 4500 | ||
|---|---|---|---|
| 001 | 1745595252 | ||
| 003 | DE-627 | ||
| 005 | 20220819084126.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 210125s2016 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1080/19466315.2016.1143391 |2 doi | |
| 035 | |a (DE-627)1745595252 | ||
| 035 | |a (DE-599)KXP1745595252 | ||
| 035 | |a (OCoLC)1341389353 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rda | ||
| 041 | |a eng | ||
| 084 | |a 33 |2 sdnb | ||
| 100 | 1 | |a Rauch, Geraldine |e VerfasserIn |0 (DE-588)139823492 |0 (DE-627)61378944X |0 (DE-576)313422923 |4 aut | |
| 245 | 1 | 0 | |a Adaptive designs for two candidate primary time-to-event endpoints |c Geraldine Rauch, Svenja Schüler, Marius Wirths, Stefan Englert, and Meinhard Kieser |
| 264 | 1 | |c 02 Jun 2016 | |
| 300 | |a 10 | ||
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Gesehen am 26.01.2021 | ||
| 520 | |a In clinical trials, the choice of an adequate primary endpoint is often difficult. Besides its clinical relevance, the endpoint must be measurable within reasonable time and must allow differentiating between the treatments. Often, the most relevant endpoint is ‘’time-to-death,” but if the overall survival prognosis is good, only a few deaths are observed during the study duration. A possible solution is to use surrogate endpoints instead. However, various examples from the literature demonstrate that surrogates do not always perform as intended. Sometimes, the surrogate effect is smaller than for the original endpoint, or the latter shows a higher effect than anticipated so using the surrogate is not reasonable. In this work, different adaptive design strategies for two candidate endpoints are proposed to solve these problems. The idea is to base the efficacy proof on the significance of at least one endpoint. At an interim analysis, both candidates are evaluated. If it is not possible to stop the study early, the sample size is recalculated based on the more promising endpoint. The new methods are illustrated by a clinical study example and compared in terms of power and sample size using Monte Carlo simulations. The software code is provided as supplementary material. | ||
| 650 | 4 | |a Clinical trial | |
| 650 | 4 | |a Multiple testing | |
| 650 | 4 | |a Sample size recalculation | |
| 700 | 1 | |a Schüler, Svenja |e VerfasserIn |0 (DE-588)1110218494 |0 (DE-627)864824718 |0 (DE-576)475751493 |4 aut | |
| 700 | 1 | |a Wirths, Marius |e VerfasserIn |0 (DE-588)1103711369 |0 (DE-627)861509447 |0 (DE-576)470755903 |4 aut | |
| 700 | 1 | |a Englert, Stefan |d 1986- |e VerfasserIn |0 (DE-588)1037466241 |0 (DE-627)755789539 |0 (DE-576)391501917 |4 aut | |
| 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 Statistics in biopharmaceutical research |d Alexandria, Va. : ASA, 2009 |g 8(2016), 2, Seite 207-216 |h Online-Ressource |w (DE-627)592552896 |w (DE-600)2480040-5 |w (DE-576)33069250X |x 1946-6315 |7 nnas |a Adaptive designs for two candidate primary time-to-event endpoints |
| 773 | 1 | 8 | |g volume:8 |g year:2016 |g number:2 |g pages:207-216 |g extent:10 |a Adaptive designs for two candidate primary time-to-event endpoints |
| 856 | 4 | 0 | |u https://doi.org/10.1080/19466315.2016.1143391 |x Verlag |x Resolving-System |z lizenzpflichtig |3 Volltext |
| 951 | |a AR | ||
| 992 | |a 20210125 | ||
| 993 | |a Article | ||
| 994 | |a 2016 | ||
| 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 5 |y j | ||
| 998 | |g 1103711369 |a Wirths, Marius |m 1103711369:Wirths, Marius |d 910000 |d 999701 |e 910000PW1103711369 |e 999701PW1103711369 |k 0/910000/ |k 1/910000/999701/ |p 3 | ||
| 998 | |g 1110218494 |a Schüler, Svenja |m 1110218494:Schüler, Svenja |d 910000 |d 999701 |e 910000PS1110218494 |e 999701PS1110218494 |k 0/910000/ |k 1/910000/999701/ |p 2 | ||
| 998 | |g 139823492 |a Rauch, Geraldine |m 139823492:Rauch, Geraldine |d 910000 |d 999701 |d 50000 |e 910000PR139823492 |e 999701PR139823492 |e 50000PR139823492 |k 0/910000/ |k 1/910000/999701/ |k 0/50000/ |p 1 |x j | ||
| 999 | |a KXP-PPN1745595252 |e 3842296843 | ||
| BIB | |a Y | ||
| SER | |a journal | ||
| JSO | |a {"relHost":[{"recId":"592552896","pubHistory":["1.2009 -"],"physDesc":[{"extent":"Online-Ressource"}],"name":{"displayForm":["American Statistical Association"]},"id":{"zdb":["2480040-5"],"eki":["592552896"],"issn":["1946-6315"]},"disp":"Adaptive designs for two candidate primary time-to-event endpointsStatistics in biopharmaceutical research","language":["eng"],"part":{"issue":"2","extent":"10","volume":"8","year":"2016","text":"8(2016), 2, Seite 207-216","pages":"207-216"},"titleAlt":[{"title":"SBR"}],"note":["Gesehen am 11.05.15"],"origin":[{"publisherPlace":"Alexandria, Va.","dateIssuedDisp":"2009-","publisher":"ASA","dateIssuedKey":"2009"}],"type":{"media":"Online-Ressource","bibl":"periodical"},"title":[{"subtitle":"SBR","title_sort":"Statistics in biopharmaceutical research","title":"Statistics in biopharmaceutical research"}]}],"id":{"eki":["1745595252"],"doi":["10.1080/19466315.2016.1143391"]},"name":{"displayForm":["Geraldine Rauch, Svenja Schüler, Marius Wirths, Stefan Englert, and Meinhard Kieser"]},"physDesc":[{"extent":"10 S."}],"recId":"1745595252","origin":[{"dateIssuedKey":"2016","dateIssuedDisp":"02 Jun 2016"}],"note":["Gesehen am 26.01.2021"],"title":[{"title":"Adaptive designs for two candidate primary time-to-event endpoints","title_sort":"Adaptive designs for two candidate primary time-to-event endpoints"}],"type":{"bibl":"article-journal","media":"Online-Ressource"},"language":["eng"],"person":[{"role":"aut","given":"Geraldine","display":"Rauch, Geraldine","family":"Rauch"},{"display":"Schüler, Svenja","family":"Schüler","given":"Svenja","role":"aut"},{"family":"Wirths","display":"Wirths, Marius","given":"Marius","role":"aut"},{"display":"Englert, Stefan","family":"Englert","role":"aut","given":"Stefan"},{"role":"aut","given":"Meinhard","display":"Kieser, Meinhard","family":"Kieser"}]} | ||
| SRT | |a RAUCHGERALADAPTIVEDE0220 | ||