In an adaptive seamless phase II/III clinical trial interim analysis, data are used for treatment selection, enabling resources to be focused on comparison of more effective treatment(s) with a control. In this paper, we compare two methods recently proposed to enable use of short-term endpoint data for decision-making at the interim analysis. The comparison focuses on the power and the probability of correctly identifying the most promising treatment. We show that the choice of method depends on how well short-term data predict the best treatment, which may be measured by the correlation between treatment effects on short- and long-term endpoints
Seamless phase II/III clinical trials combine traditional phases II and III into a single trial that...
Incorporating an emerging therapy as a new randomisation arm in a clinical trial that is open to rec...
The question of how individual patient data from cohort studies or historical clinical trials can be...
Seamless phase II/III clinical trials are conducted in two stages with treatment selection at the fi...
Seamless phase II/III clinical trials in which an experimental treatment is selected at an interim a...
In an adaptive seamless phase II/III clinical trial interim analysis, data are used for treatment se...
AbstractOverall survival (OS) has emerged as the definitive regulatory “be-all, end-all” for the dem...
Seamless phase II/III designs allow strong control of the familywise type I error rate when the most...
This article is a later version of the author\u27s presentation at the Eleventh Annual Honorable Hel...
Phase II/III clinical trials are efficient two‐stage designs that test multiple experimental treatme...
AbstractBackgroundThe high failure rate in phase III oncology trials is partly because the signal ob...
In oncology clinical trial, overall survival (OS) benefit is the gold standard for the approval of n...
Adaptive designs are increasingly adopted to make the process of drug development more efficient. In...
Numerous human medical problems or diseases have been aided by the development of effective treatmen...
Several important questions have been raised about decision of stopping a trial early and on what ba...
Seamless phase II/III clinical trials combine traditional phases II and III into a single trial that...
Incorporating an emerging therapy as a new randomisation arm in a clinical trial that is open to rec...
The question of how individual patient data from cohort studies or historical clinical trials can be...
Seamless phase II/III clinical trials are conducted in two stages with treatment selection at the fi...
Seamless phase II/III clinical trials in which an experimental treatment is selected at an interim a...
In an adaptive seamless phase II/III clinical trial interim analysis, data are used for treatment se...
AbstractOverall survival (OS) has emerged as the definitive regulatory “be-all, end-all” for the dem...
Seamless phase II/III designs allow strong control of the familywise type I error rate when the most...
This article is a later version of the author\u27s presentation at the Eleventh Annual Honorable Hel...
Phase II/III clinical trials are efficient two‐stage designs that test multiple experimental treatme...
AbstractBackgroundThe high failure rate in phase III oncology trials is partly because the signal ob...
In oncology clinical trial, overall survival (OS) benefit is the gold standard for the approval of n...
Adaptive designs are increasingly adopted to make the process of drug development more efficient. In...
Numerous human medical problems or diseases have been aided by the development of effective treatmen...
Several important questions have been raised about decision of stopping a trial early and on what ba...
Seamless phase II/III clinical trials combine traditional phases II and III into a single trial that...
Incorporating an emerging therapy as a new randomisation arm in a clinical trial that is open to rec...
The question of how individual patient data from cohort studies or historical clinical trials can be...