Performance of adaptive designs for single-armed phase II oncology trials
When planning a single-armed clinical trial with binary endpoint, the sample size is determined such that the desired power is achieved for a single value of the target rate. However, there is usually some uncertainty with respect to the true treatment effect. It is therefore more realistic to speci...
Gespeichert in:
| Hauptverfasser: | , |
|---|---|
| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
15 Apr 2015
|
| In: |
Journal of biopharmaceutical statistics
Year: 2015, Jahrgang: 25, Heft: 3, Pages: 602-615 |
| ISSN: | 1520-5711 |
| DOI: | 10.1080/10543406.2014.920863 |
| Online-Zugang: | Resolving-System, lizenzpflichtig, Volltext: https://doi.org/10.1080/10543406.2014.920863 Verlag, lizenzpflichtig, Volltext: https://www.tandfonline.com/doi/full/10.1080/10543406.2014.920863 
|
| Verfasserangaben: | Meinhard Kieser and Stefan Englert |
MARC
| LEADER | 00000caa a2200000 c 4500 | ||
|---|---|---|---|
| 001 | 1703021738 | ||
| 003 | DE-627 | ||
| 005 | 20240529103026.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 200701s2015 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1080/10543406.2014.920863 |2 doi | |
| 035 | |a (DE-627)1703021738 | ||
| 035 | |a (DE-599)KXP1703021738 | ||
| 035 | |a (OCoLC)1341342215 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rda | ||
| 041 | |a eng | ||
| 084 | |a 33 |2 sdnb | ||
| 100 | 1 | |a Kieser, Meinhard |d 1960- |e VerfasserIn |0 (DE-588)103276547X |0 (DE-627)739277766 |0 (DE-576)168963825 |4 aut | |
| 245 | 1 | 0 | |a Performance of adaptive designs for single-armed phase II oncology trials |c Meinhard Kieser and Stefan Englert |
| 264 | 1 | |c 15 Apr 2015 | |
| 300 | |a 14 | ||
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Accepted author version posted online: 06 Jun 2014 | ||
| 500 | |a Gesehen am 01.07.2020 | ||
| 520 | |a When planning a single-armed clinical trial with binary endpoint, the sample size is determined such that the desired power is achieved for a single value of the target rate. However, there is usually some uncertainty with respect to the true treatment effect. It is therefore more realistic to specify an interval for the possible true rate to accommodate this uncertainty. For this situation, we examine comprehensively the overall performance of various Phase II oncology designs and sample size recalculation strategies. The methods and results of our investigations can be used to identify the most appropriate approach for a specific clinical trial situation at hand. Application is illustrated with a clinical trial in rectal cancer. | ||
| 650 | 4 | |a Adaptive design | |
| 650 | 4 | |a Average performance score | |
| 650 | 4 | |a Phase II | |
| 650 | 4 | |a Sample size recalculation | |
| 650 | 4 | |a Single-armed clinical trial | |
| 650 | 4 | |a Two-stage design | |
| 700 | 1 | |a Englert, Stefan |d 1986- |e VerfasserIn |0 (DE-588)1037466241 |0 (DE-627)755789539 |0 (DE-576)391501917 |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Journal of biopharmaceutical statistics |d Philadelphia, PA : Taylor & Francis, 1991 |g 25(2015), 3, Seite 602-615 |h Online-Ressource |w (DE-627)32047416X |w (DE-600)2008925-9 |w (DE-576)27387828X |x 1520-5711 |7 nnas |a Performance of adaptive designs for single-armed phase II oncology trials |
| 773 | 1 | 8 | |g volume:25 |g year:2015 |g number:3 |g pages:602-615 |g extent:14 |a Performance of adaptive designs for single-armed phase II oncology trials |
| 856 | 4 | 0 | |u https://doi.org/10.1080/10543406.2014.920863 |x Resolving-System |x Verlag |z lizenzpflichtig |3 Volltext |
| 856 | 4 | 0 | |u https://www.tandfonline.com/doi/full/10.1080/10543406.2014.920863 |x Verlag |z lizenzpflichtig |3 Volltext |
| 951 | |a AR | ||
| 992 | |a 20200701 | ||
| 993 | |a Article | ||
| 994 | |a 2015 | ||
| 998 | |g 1037466241 |a Englert, Stefan |m 1037466241:Englert, Stefan |p 2 |y j | ||
| 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 1 |x j | ||
| 999 | |a KXP-PPN1703021738 |e 3692636946 | ||
| BIB | |a Y | ||
| SER | |a journal | ||
| JSO | |a {"title":[{"title_sort":"Performance of adaptive designs for single-armed phase II oncology trials","title":"Performance of adaptive designs for single-armed phase II oncology trials"}],"person":[{"role":"aut","display":"Kieser, Meinhard","family":"Kieser","given":"Meinhard"},{"role":"aut","display":"Englert, Stefan","family":"Englert","given":"Stefan"}],"type":{"bibl":"article-journal","media":"Online-Ressource"},"origin":[{"dateIssuedDisp":"15 Apr 2015","dateIssuedKey":"2015"}],"note":["Accepted author version posted online: 06 Jun 2014","Gesehen am 01.07.2020"],"id":{"eki":["1703021738"],"doi":["10.1080/10543406.2014.920863"]},"recId":"1703021738","relHost":[{"note":["Gesehen am 28.11.11"],"type":{"bibl":"periodical","media":"Online-Ressource"},"origin":[{"dateIssuedKey":"1991","publisherPlace":"Philadelphia, PA ; New York, NY","dateIssuedDisp":"1991-","publisher":"Taylor & Francis ; Dekker"}],"pubHistory":["1.1991 -"],"title":[{"title":"Journal of biopharmaceutical statistics","subtitle":"JBS","title_sort":"Journal of biopharmaceutical statistics"}],"language":["eng"],"part":{"pages":"602-615","volume":"25","extent":"14","issue":"3","year":"2015","text":"25(2015), 3, Seite 602-615"},"disp":"Performance of adaptive designs for single-armed phase II oncology trialsJournal of biopharmaceutical statistics","physDesc":[{"extent":"Online-Ressource"}],"titleAlt":[{"title":"JBS"}],"recId":"32047416X","id":{"eki":["32047416X"],"zdb":["2008925-9"],"issn":["1520-5711"]}}],"name":{"displayForm":["Meinhard Kieser and Stefan Englert"]},"physDesc":[{"extent":"14 S."}],"language":["eng"]} | ||
| SRT | |a KIESERMEINPERFORMANC1520 | ||