Two-stage winner designs for non-inferiority trials with pre-specified non-inferiority margin
In drug development, a two-stage winner design (Lan et al. 2005, Shun et al. 2008) can be cost-effective when the best treatment is to be determined from multiple experimental treatments in superiority trials. However, the statistical methods assessing non-inferiority in a two-stage winner design ha...
Ausführliche Beschreibung
Autor*in: |
Wang, Pin-Wen [verfasserIn] |
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E-Artikel |
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Sprache: |
Englisch |
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2017transfer abstract |
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18 |
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Übergeordnetes Werk: |
Enthalten in: Experimental investigation of long-wavelength optical lattice vibrations in quaternary Al x In y Ga1−x−y N alloys and comparison with results from the pseudo-unit cell model - 2011transfer abstract, JSPI, Amsterdam |
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Übergeordnetes Werk: |
volume:183 ; year:2017 ; pages:44-61 ; extent:18 |
Links: |
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DOI / URN: |
10.1016/j.jspi.2016.10.001 |
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ELV035937262 |
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520 | |a In drug development, a two-stage winner design (Lan et al. 2005, Shun et al. 2008) can be cost-effective when the best treatment is to be determined from multiple experimental treatments in superiority trials. However, the statistical methods assessing non-inferiority in a two-stage winner design have not yet been studied, for which the complexity arises in determining the critical value when parameter space is not a single point under the null hypothesis. Because the maximum error may not occur at the vertex of the null space, it is unclear if naive use of critical values and distributional results from the test for superiority remains correct. In this paper, we provided rigorous justifications to determine the critical value for testing non-inferiority hypothesis, with a pre-specified non-inferiority margin, in a two-stage winner design with two experimental treatments and an active control. We studied the distribution of the test statistics, critical values, sample size and power calculations using the exact distribution of the test statistics as well as using normal approximations. Theoretical justifications and extensive numerical assessments were conducted to calculate the design parameters and evaluate the performance of our methods. | ||
520 | |a In drug development, a two-stage winner design (Lan et al. 2005, Shun et al. 2008) can be cost-effective when the best treatment is to be determined from multiple experimental treatments in superiority trials. However, the statistical methods assessing non-inferiority in a two-stage winner design have not yet been studied, for which the complexity arises in determining the critical value when parameter space is not a single point under the null hypothesis. Because the maximum error may not occur at the vertex of the null space, it is unclear if naive use of critical values and distributional results from the test for superiority remains correct. In this paper, we provided rigorous justifications to determine the critical value for testing non-inferiority hypothesis, with a pre-specified non-inferiority margin, in a two-stage winner design with two experimental treatments and an active control. We studied the distribution of the test statistics, critical values, sample size and power calculations using the exact distribution of the test statistics as well as using normal approximations. Theoretical justifications and extensive numerical assessments were conducted to calculate the design parameters and evaluate the performance of our methods. | ||
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700 | 1 | |a Lan, K.K. Gordon |4 oth | |
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10.1016/j.jspi.2016.10.001 doi GBVA2017012000030.pica (DE-627)ELV035937262 (ELSEVIER)S0378-3758(16)30123-9 DE-627 ger DE-627 rakwb eng 510 000 310 510 DE-600 000 DE-600 310 DE-600 530 VZ 540 VZ 51.30 bkl Wang, Pin-Wen verfasserin aut Two-stage winner designs for non-inferiority trials with pre-specified non-inferiority margin 2017transfer abstract 18 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier In drug development, a two-stage winner design (Lan et al. 2005, Shun et al. 2008) can be cost-effective when the best treatment is to be determined from multiple experimental treatments in superiority trials. However, the statistical methods assessing non-inferiority in a two-stage winner design have not yet been studied, for which the complexity arises in determining the critical value when parameter space is not a single point under the null hypothesis. Because the maximum error may not occur at the vertex of the null space, it is unclear if naive use of critical values and distributional results from the test for superiority remains correct. In this paper, we provided rigorous justifications to determine the critical value for testing non-inferiority hypothesis, with a pre-specified non-inferiority margin, in a two-stage winner design with two experimental treatments and an active control. We studied the distribution of the test statistics, critical values, sample size and power calculations using the exact distribution of the test statistics as well as using normal approximations. Theoretical justifications and extensive numerical assessments were conducted to calculate the design parameters and evaluate the performance of our methods. In drug development, a two-stage winner design (Lan et al. 2005, Shun et al. 2008) can be cost-effective when the best treatment is to be determined from multiple experimental treatments in superiority trials. However, the statistical methods assessing non-inferiority in a two-stage winner design have not yet been studied, for which the complexity arises in determining the critical value when parameter space is not a single point under the null hypothesis. Because the maximum error may not occur at the vertex of the null space, it is unclear if naive use of critical values and distributional results from the test for superiority remains correct. In this paper, we provided rigorous justifications to determine the critical value for testing non-inferiority hypothesis, with a pre-specified non-inferiority margin, in a two-stage winner design with two experimental treatments and an active control. We studied the distribution of the test statistics, critical values, sample size and power calculations using the exact distribution of the test statistics as well as using normal approximations. Theoretical justifications and extensive numerical assessments were conducted to calculate the design parameters and evaluate the performance of our methods. Adaptive design Elsevier Two-stage design Elsevier Non-inferiority trials Elsevier Lu, Shou-En oth Lin, Yong oth Shih, Weichung J. oth Lan, K.K. Gordon oth Enthalten in North-Holland Publ. Co Experimental investigation of long-wavelength optical lattice vibrations in quaternary Al x In y Ga1−x−y N alloys and comparison with results from the pseudo-unit cell model 2011transfer abstract JSPI Amsterdam (DE-627)ELV020955464 volume:183 year:2017 pages:44-61 extent:18 https://doi.org/10.1016/j.jspi.2016.10.001 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA GBV_ILN_26 GBV_ILN_60 GBV_ILN_160 GBV_ILN_2009 GBV_ILN_2099 51.30 Werkstoffprüfung Werkstoffuntersuchung VZ AR 183 2017 44-61 18 045F 510 |
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10.1016/j.jspi.2016.10.001 doi GBVA2017012000030.pica (DE-627)ELV035937262 (ELSEVIER)S0378-3758(16)30123-9 DE-627 ger DE-627 rakwb eng 510 000 310 510 DE-600 000 DE-600 310 DE-600 530 VZ 540 VZ 51.30 bkl Wang, Pin-Wen verfasserin aut Two-stage winner designs for non-inferiority trials with pre-specified non-inferiority margin 2017transfer abstract 18 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier In drug development, a two-stage winner design (Lan et al. 2005, Shun et al. 2008) can be cost-effective when the best treatment is to be determined from multiple experimental treatments in superiority trials. However, the statistical methods assessing non-inferiority in a two-stage winner design have not yet been studied, for which the complexity arises in determining the critical value when parameter space is not a single point under the null hypothesis. Because the maximum error may not occur at the vertex of the null space, it is unclear if naive use of critical values and distributional results from the test for superiority remains correct. In this paper, we provided rigorous justifications to determine the critical value for testing non-inferiority hypothesis, with a pre-specified non-inferiority margin, in a two-stage winner design with two experimental treatments and an active control. We studied the distribution of the test statistics, critical values, sample size and power calculations using the exact distribution of the test statistics as well as using normal approximations. Theoretical justifications and extensive numerical assessments were conducted to calculate the design parameters and evaluate the performance of our methods. In drug development, a two-stage winner design (Lan et al. 2005, Shun et al. 2008) can be cost-effective when the best treatment is to be determined from multiple experimental treatments in superiority trials. However, the statistical methods assessing non-inferiority in a two-stage winner design have not yet been studied, for which the complexity arises in determining the critical value when parameter space is not a single point under the null hypothesis. Because the maximum error may not occur at the vertex of the null space, it is unclear if naive use of critical values and distributional results from the test for superiority remains correct. In this paper, we provided rigorous justifications to determine the critical value for testing non-inferiority hypothesis, with a pre-specified non-inferiority margin, in a two-stage winner design with two experimental treatments and an active control. We studied the distribution of the test statistics, critical values, sample size and power calculations using the exact distribution of the test statistics as well as using normal approximations. Theoretical justifications and extensive numerical assessments were conducted to calculate the design parameters and evaluate the performance of our methods. Adaptive design Elsevier Two-stage design Elsevier Non-inferiority trials Elsevier Lu, Shou-En oth Lin, Yong oth Shih, Weichung J. oth Lan, K.K. Gordon oth Enthalten in North-Holland Publ. Co Experimental investigation of long-wavelength optical lattice vibrations in quaternary Al x In y Ga1−x−y N alloys and comparison with results from the pseudo-unit cell model 2011transfer abstract JSPI Amsterdam (DE-627)ELV020955464 volume:183 year:2017 pages:44-61 extent:18 https://doi.org/10.1016/j.jspi.2016.10.001 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA GBV_ILN_26 GBV_ILN_60 GBV_ILN_160 GBV_ILN_2009 GBV_ILN_2099 51.30 Werkstoffprüfung Werkstoffuntersuchung VZ AR 183 2017 44-61 18 045F 510 |
allfields_unstemmed |
10.1016/j.jspi.2016.10.001 doi GBVA2017012000030.pica (DE-627)ELV035937262 (ELSEVIER)S0378-3758(16)30123-9 DE-627 ger DE-627 rakwb eng 510 000 310 510 DE-600 000 DE-600 310 DE-600 530 VZ 540 VZ 51.30 bkl Wang, Pin-Wen verfasserin aut Two-stage winner designs for non-inferiority trials with pre-specified non-inferiority margin 2017transfer abstract 18 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier In drug development, a two-stage winner design (Lan et al. 2005, Shun et al. 2008) can be cost-effective when the best treatment is to be determined from multiple experimental treatments in superiority trials. However, the statistical methods assessing non-inferiority in a two-stage winner design have not yet been studied, for which the complexity arises in determining the critical value when parameter space is not a single point under the null hypothesis. Because the maximum error may not occur at the vertex of the null space, it is unclear if naive use of critical values and distributional results from the test for superiority remains correct. In this paper, we provided rigorous justifications to determine the critical value for testing non-inferiority hypothesis, with a pre-specified non-inferiority margin, in a two-stage winner design with two experimental treatments and an active control. We studied the distribution of the test statistics, critical values, sample size and power calculations using the exact distribution of the test statistics as well as using normal approximations. Theoretical justifications and extensive numerical assessments were conducted to calculate the design parameters and evaluate the performance of our methods. In drug development, a two-stage winner design (Lan et al. 2005, Shun et al. 2008) can be cost-effective when the best treatment is to be determined from multiple experimental treatments in superiority trials. However, the statistical methods assessing non-inferiority in a two-stage winner design have not yet been studied, for which the complexity arises in determining the critical value when parameter space is not a single point under the null hypothesis. Because the maximum error may not occur at the vertex of the null space, it is unclear if naive use of critical values and distributional results from the test for superiority remains correct. In this paper, we provided rigorous justifications to determine the critical value for testing non-inferiority hypothesis, with a pre-specified non-inferiority margin, in a two-stage winner design with two experimental treatments and an active control. We studied the distribution of the test statistics, critical values, sample size and power calculations using the exact distribution of the test statistics as well as using normal approximations. Theoretical justifications and extensive numerical assessments were conducted to calculate the design parameters and evaluate the performance of our methods. Adaptive design Elsevier Two-stage design Elsevier Non-inferiority trials Elsevier Lu, Shou-En oth Lin, Yong oth Shih, Weichung J. oth Lan, K.K. Gordon oth Enthalten in North-Holland Publ. Co Experimental investigation of long-wavelength optical lattice vibrations in quaternary Al x In y Ga1−x−y N alloys and comparison with results from the pseudo-unit cell model 2011transfer abstract JSPI Amsterdam (DE-627)ELV020955464 volume:183 year:2017 pages:44-61 extent:18 https://doi.org/10.1016/j.jspi.2016.10.001 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA GBV_ILN_26 GBV_ILN_60 GBV_ILN_160 GBV_ILN_2009 GBV_ILN_2099 51.30 Werkstoffprüfung Werkstoffuntersuchung VZ AR 183 2017 44-61 18 045F 510 |
allfieldsGer |
10.1016/j.jspi.2016.10.001 doi GBVA2017012000030.pica (DE-627)ELV035937262 (ELSEVIER)S0378-3758(16)30123-9 DE-627 ger DE-627 rakwb eng 510 000 310 510 DE-600 000 DE-600 310 DE-600 530 VZ 540 VZ 51.30 bkl Wang, Pin-Wen verfasserin aut Two-stage winner designs for non-inferiority trials with pre-specified non-inferiority margin 2017transfer abstract 18 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier In drug development, a two-stage winner design (Lan et al. 2005, Shun et al. 2008) can be cost-effective when the best treatment is to be determined from multiple experimental treatments in superiority trials. However, the statistical methods assessing non-inferiority in a two-stage winner design have not yet been studied, for which the complexity arises in determining the critical value when parameter space is not a single point under the null hypothesis. Because the maximum error may not occur at the vertex of the null space, it is unclear if naive use of critical values and distributional results from the test for superiority remains correct. In this paper, we provided rigorous justifications to determine the critical value for testing non-inferiority hypothesis, with a pre-specified non-inferiority margin, in a two-stage winner design with two experimental treatments and an active control. We studied the distribution of the test statistics, critical values, sample size and power calculations using the exact distribution of the test statistics as well as using normal approximations. Theoretical justifications and extensive numerical assessments were conducted to calculate the design parameters and evaluate the performance of our methods. In drug development, a two-stage winner design (Lan et al. 2005, Shun et al. 2008) can be cost-effective when the best treatment is to be determined from multiple experimental treatments in superiority trials. However, the statistical methods assessing non-inferiority in a two-stage winner design have not yet been studied, for which the complexity arises in determining the critical value when parameter space is not a single point under the null hypothesis. Because the maximum error may not occur at the vertex of the null space, it is unclear if naive use of critical values and distributional results from the test for superiority remains correct. In this paper, we provided rigorous justifications to determine the critical value for testing non-inferiority hypothesis, with a pre-specified non-inferiority margin, in a two-stage winner design with two experimental treatments and an active control. We studied the distribution of the test statistics, critical values, sample size and power calculations using the exact distribution of the test statistics as well as using normal approximations. Theoretical justifications and extensive numerical assessments were conducted to calculate the design parameters and evaluate the performance of our methods. Adaptive design Elsevier Two-stage design Elsevier Non-inferiority trials Elsevier Lu, Shou-En oth Lin, Yong oth Shih, Weichung J. oth Lan, K.K. Gordon oth Enthalten in North-Holland Publ. Co Experimental investigation of long-wavelength optical lattice vibrations in quaternary Al x In y Ga1−x−y N alloys and comparison with results from the pseudo-unit cell model 2011transfer abstract JSPI Amsterdam (DE-627)ELV020955464 volume:183 year:2017 pages:44-61 extent:18 https://doi.org/10.1016/j.jspi.2016.10.001 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA GBV_ILN_26 GBV_ILN_60 GBV_ILN_160 GBV_ILN_2009 GBV_ILN_2099 51.30 Werkstoffprüfung Werkstoffuntersuchung VZ AR 183 2017 44-61 18 045F 510 |
allfieldsSound |
10.1016/j.jspi.2016.10.001 doi GBVA2017012000030.pica (DE-627)ELV035937262 (ELSEVIER)S0378-3758(16)30123-9 DE-627 ger DE-627 rakwb eng 510 000 310 510 DE-600 000 DE-600 310 DE-600 530 VZ 540 VZ 51.30 bkl Wang, Pin-Wen verfasserin aut Two-stage winner designs for non-inferiority trials with pre-specified non-inferiority margin 2017transfer abstract 18 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier In drug development, a two-stage winner design (Lan et al. 2005, Shun et al. 2008) can be cost-effective when the best treatment is to be determined from multiple experimental treatments in superiority trials. However, the statistical methods assessing non-inferiority in a two-stage winner design have not yet been studied, for which the complexity arises in determining the critical value when parameter space is not a single point under the null hypothesis. Because the maximum error may not occur at the vertex of the null space, it is unclear if naive use of critical values and distributional results from the test for superiority remains correct. In this paper, we provided rigorous justifications to determine the critical value for testing non-inferiority hypothesis, with a pre-specified non-inferiority margin, in a two-stage winner design with two experimental treatments and an active control. We studied the distribution of the test statistics, critical values, sample size and power calculations using the exact distribution of the test statistics as well as using normal approximations. Theoretical justifications and extensive numerical assessments were conducted to calculate the design parameters and evaluate the performance of our methods. In drug development, a two-stage winner design (Lan et al. 2005, Shun et al. 2008) can be cost-effective when the best treatment is to be determined from multiple experimental treatments in superiority trials. However, the statistical methods assessing non-inferiority in a two-stage winner design have not yet been studied, for which the complexity arises in determining the critical value when parameter space is not a single point under the null hypothesis. Because the maximum error may not occur at the vertex of the null space, it is unclear if naive use of critical values and distributional results from the test for superiority remains correct. In this paper, we provided rigorous justifications to determine the critical value for testing non-inferiority hypothesis, with a pre-specified non-inferiority margin, in a two-stage winner design with two experimental treatments and an active control. We studied the distribution of the test statistics, critical values, sample size and power calculations using the exact distribution of the test statistics as well as using normal approximations. Theoretical justifications and extensive numerical assessments were conducted to calculate the design parameters and evaluate the performance of our methods. Adaptive design Elsevier Two-stage design Elsevier Non-inferiority trials Elsevier Lu, Shou-En oth Lin, Yong oth Shih, Weichung J. oth Lan, K.K. Gordon oth Enthalten in North-Holland Publ. Co Experimental investigation of long-wavelength optical lattice vibrations in quaternary Al x In y Ga1−x−y N alloys and comparison with results from the pseudo-unit cell model 2011transfer abstract JSPI Amsterdam (DE-627)ELV020955464 volume:183 year:2017 pages:44-61 extent:18 https://doi.org/10.1016/j.jspi.2016.10.001 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA GBV_ILN_26 GBV_ILN_60 GBV_ILN_160 GBV_ILN_2009 GBV_ILN_2099 51.30 Werkstoffprüfung Werkstoffuntersuchung VZ AR 183 2017 44-61 18 045F 510 |
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English |
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Enthalten in Experimental investigation of long-wavelength optical lattice vibrations in quaternary Al x In y Ga1−x−y N alloys and comparison with results from the pseudo-unit cell model Amsterdam volume:183 year:2017 pages:44-61 extent:18 |
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Enthalten in Experimental investigation of long-wavelength optical lattice vibrations in quaternary Al x In y Ga1−x−y N alloys and comparison with results from the pseudo-unit cell model Amsterdam volume:183 year:2017 pages:44-61 extent:18 |
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Experimental investigation of long-wavelength optical lattice vibrations in quaternary Al x In y Ga1−x−y N alloys and comparison with results from the pseudo-unit cell model |
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two-stage winner designs for non-inferiority trials with pre-specified non-inferiority margin |
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Two-stage winner designs for non-inferiority trials with pre-specified non-inferiority margin |
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In drug development, a two-stage winner design (Lan et al. 2005, Shun et al. 2008) can be cost-effective when the best treatment is to be determined from multiple experimental treatments in superiority trials. However, the statistical methods assessing non-inferiority in a two-stage winner design have not yet been studied, for which the complexity arises in determining the critical value when parameter space is not a single point under the null hypothesis. Because the maximum error may not occur at the vertex of the null space, it is unclear if naive use of critical values and distributional results from the test for superiority remains correct. In this paper, we provided rigorous justifications to determine the critical value for testing non-inferiority hypothesis, with a pre-specified non-inferiority margin, in a two-stage winner design with two experimental treatments and an active control. We studied the distribution of the test statistics, critical values, sample size and power calculations using the exact distribution of the test statistics as well as using normal approximations. Theoretical justifications and extensive numerical assessments were conducted to calculate the design parameters and evaluate the performance of our methods. |
abstractGer |
In drug development, a two-stage winner design (Lan et al. 2005, Shun et al. 2008) can be cost-effective when the best treatment is to be determined from multiple experimental treatments in superiority trials. However, the statistical methods assessing non-inferiority in a two-stage winner design have not yet been studied, for which the complexity arises in determining the critical value when parameter space is not a single point under the null hypothesis. Because the maximum error may not occur at the vertex of the null space, it is unclear if naive use of critical values and distributional results from the test for superiority remains correct. In this paper, we provided rigorous justifications to determine the critical value for testing non-inferiority hypothesis, with a pre-specified non-inferiority margin, in a two-stage winner design with two experimental treatments and an active control. We studied the distribution of the test statistics, critical values, sample size and power calculations using the exact distribution of the test statistics as well as using normal approximations. Theoretical justifications and extensive numerical assessments were conducted to calculate the design parameters and evaluate the performance of our methods. |
abstract_unstemmed |
In drug development, a two-stage winner design (Lan et al. 2005, Shun et al. 2008) can be cost-effective when the best treatment is to be determined from multiple experimental treatments in superiority trials. However, the statistical methods assessing non-inferiority in a two-stage winner design have not yet been studied, for which the complexity arises in determining the critical value when parameter space is not a single point under the null hypothesis. Because the maximum error may not occur at the vertex of the null space, it is unclear if naive use of critical values and distributional results from the test for superiority remains correct. In this paper, we provided rigorous justifications to determine the critical value for testing non-inferiority hypothesis, with a pre-specified non-inferiority margin, in a two-stage winner design with two experimental treatments and an active control. We studied the distribution of the test statistics, critical values, sample size and power calculations using the exact distribution of the test statistics as well as using normal approximations. Theoretical justifications and extensive numerical assessments were conducted to calculate the design parameters and evaluate the performance of our methods. |
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Two-stage winner designs for non-inferiority trials with pre-specified non-inferiority margin |
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