scholarly journals Assessing the impact of safety monitoring on the efficacy analysis in large Phase III group sequential trials with non-trivial safety event rate

2015 ◽  
Vol 26 (4) ◽  
pp. 672-685
Author(s):  
Yanqiu Weng ◽  
Yuko Y. Palesch ◽  
Stacia M. DeSantis ◽  
Wenle Zhao
Keyword(s):  
Event Rate ◽  
Safety Monitoring ◽  
Phase Iii ◽  
Group Sequential ◽  
Efficacy Analysis ◽  
Group Sequential Trials ◽  
Safety Event ◽  
Large Phase ◽  
Sequential Trials ◽  
The Impact

Approximately Optimal One-Parameter Boundaries for Group Sequential Trials

Biometrics ◽  
1987 ◽  
Vol 43 (1) ◽  
pp. 193 ◽  
Author(s):  
Samuel K. Wang ◽  
Anastasios A. Tsiatis
Keyword(s):  
Group Sequential ◽  
Group Sequential Trials ◽  
Sequential Trials

Exact Statistical Inference for Group Sequential Trials

Biometrics ◽  
1991 ◽  
Vol 47 (4) ◽  
pp. 1399 ◽  
Author(s):  
D. Y. Lin ◽  
L. J. Wei ◽  
D. L. DeMets
Keyword(s):  
Statistical Inference ◽  
Group Sequential ◽  
Group Sequential Trials ◽  
Sequential Trials ◽  
Exact Statistical Inference

Incorporating Surrogate Endpoints into Group Sequential Trials

1996 ◽  
Vol 38 (1) ◽  
pp. 119-130 ◽  
Author(s):  
Richard J. Cook ◽  
Vern T. Farewell
Keyword(s):  
Surrogate Endpoints ◽  
Group Sequential ◽  
Group Sequential Trials ◽  
Sequential Trials

scholarly journals Overestimation of the Effect Size in Group Sequential Trials

2012 ◽  
Vol 18 (18) ◽  
pp. 4872-4876 ◽  
Author(s):  
Jenny J. Zhang ◽  
Gideon M. Blumenthal ◽  
Kun He ◽  
Shenghui Tang ◽  
Patricia Cortazar ◽  
...  
Keyword(s):  
Effect Size ◽  
Group Sequential ◽  
Group Sequential Trials ◽  
Sequential Trials
Sign in / Sign up

Export Citation Format

Share Document