Group sequential multi-arm multi-stage survival trial design with treatment selection
Multi-arm trials are increasingly of interest because for many diseases; there are multiple experimental treatments available for testing efficacy. Several novel multi-arm multi-stage (MAMS) clinical trial designs have been proposed. However, a major hurdle to adopting the group sequential MAMS routinely is the computational effort of obtaining stopping boundaries. For example, the method of Jaki and Magirr for time-to-event endpoint, implemented in R package MAMS, requires complicated computational efforts to obtain stopping boundaries. In this study, we develop a group sequential MAMS survival trial design based on the sequential conditional probability ratio test. The proposed method is an improvement of the Jaki and Magirr's method in the following three directions. First, the proposed method provides explicit solutions for both futility and efficacy boundaries to an arbitrary number of stages and arms. Thus, it avoids complicated computational efforts for the trial design. Second, the proposed method provides an accurate number of events for the fixed sample and group sequential designs. Third, the proposed method uses a new procedure for interim analysis which preserves the study power.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2023 |
|---|---|
| Enthalten in: |
Journal of biopharmaceutical statistics - (2023) vom: 16. Juli, Seite 1-16 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Wu, Jianrong [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Group sequential design |
|---|
| Anmerkungen: |
Date Revised 17.07.2023 published: Print-Electronic Citation Status Publisher |
|---|
| doi: |
10.1080/10543406.2023.2235409 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM35956108X |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM35956108X | ||
| 003 | DE-627 | ||
| 005 | 20231226081136.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1080/10543406.2023.2235409 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1198.xml |
| 035 | |a (DE-627)NLM35956108X | ||
| 035 | |a (NLM)37455424 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Wu, Jianrong |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Group sequential multi-arm multi-stage survival trial design with treatment selection |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Revised 17.07.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status Publisher | ||
| 520 | |a Multi-arm trials are increasingly of interest because for many diseases; there are multiple experimental treatments available for testing efficacy. Several novel multi-arm multi-stage (MAMS) clinical trial designs have been proposed. However, a major hurdle to adopting the group sequential MAMS routinely is the computational effort of obtaining stopping boundaries. For example, the method of Jaki and Magirr for time-to-event endpoint, implemented in R package MAMS, requires complicated computational efforts to obtain stopping boundaries. In this study, we develop a group sequential MAMS survival trial design based on the sequential conditional probability ratio test. The proposed method is an improvement of the Jaki and Magirr's method in the following three directions. First, the proposed method provides explicit solutions for both futility and efficacy boundaries to an arbitrary number of stages and arms. Thus, it avoids complicated computational efforts for the trial design. Second, the proposed method provides an accurate number of events for the fixed sample and group sequential designs. Third, the proposed method uses a new procedure for interim analysis which preserves the study power | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multi-arm multi-stage | |
| 650 | 4 | |a group sequential design | |
| 650 | 4 | |a log-rank test | |
| 650 | 4 | |a sequential conditional probability ratio test | |
| 650 | 4 | |a time-to-event | |
| 700 | 1 | |a Li, Yimei |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Journal of biopharmaceutical statistics |d 1991 |g (2023) vom: 16. Juli, Seite 1-16 |w (DE-627)NLM012811432 |x 1520-5711 |7 nnns |
| 773 | 1 | 8 | |g year:2023 |g day:16 |g month:07 |g pages:1-16 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1080/10543406.2023.2235409 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |j 2023 |b 16 |c 07 |h 1-16 | ||