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
<p>Oncology drug developers sometimes decide to initiate Phase III randomized confirmatory trials at...
Seamless phase II/III clinical trials are attractive in development of new drugs because they accele...
Seamless phase II/III clinical trials combine traditional phases II and III into a single trial that...
Seamless phase II/III clinical trials are conducted in two stages with treatment selection at the fi...
Seamless phase II/III designs allow strong control of the familywise type I error rate when the most...
The last 10 years have seen considerable interest in clinical trial designs that allow the seamless ...
This paper discusses interim analysis for clinical trials where the primary endpoint is observed at ...
Most statistical methodology for phase III clinical trials focuses on the comparison of a single exp...
Designs incorporating more than one endpoint have become popular in drug development. One of such de...
Conditional power calculations are frequently used to guide the decision whether or not to stop a tr...
Interim analyses are routinely used to monitor accumulating data in clinical trials. When the object...
Interim analyses are routinely used to monitor accumulating data in clinical trials. When the object...
Aims For ethical and economic reasons, interim analysis of phase III clinical trials is essential. T...
Aims For ethical and economic reasons, interim analysis of phase III clinical trials is essential. T...
In an adaptive seamless phase II/III clinical trial interim analysis, data are used for treatment se...
<p>Oncology drug developers sometimes decide to initiate Phase III randomized confirmatory trials at...
Seamless phase II/III clinical trials are attractive in development of new drugs because they accele...
Seamless phase II/III clinical trials combine traditional phases II and III into a single trial that...
Seamless phase II/III clinical trials are conducted in two stages with treatment selection at the fi...
Seamless phase II/III designs allow strong control of the familywise type I error rate when the most...
The last 10 years have seen considerable interest in clinical trial designs that allow the seamless ...
This paper discusses interim analysis for clinical trials where the primary endpoint is observed at ...
Most statistical methodology for phase III clinical trials focuses on the comparison of a single exp...
Designs incorporating more than one endpoint have become popular in drug development. One of such de...
Conditional power calculations are frequently used to guide the decision whether or not to stop a tr...
Interim analyses are routinely used to monitor accumulating data in clinical trials. When the object...
Interim analyses are routinely used to monitor accumulating data in clinical trials. When the object...
Aims For ethical and economic reasons, interim analysis of phase III clinical trials is essential. T...
Aims For ethical and economic reasons, interim analysis of phase III clinical trials is essential. T...
In an adaptive seamless phase II/III clinical trial interim analysis, data are used for treatment se...
<p>Oncology drug developers sometimes decide to initiate Phase III randomized confirmatory trials at...
Seamless phase II/III clinical trials are attractive in development of new drugs because they accele...
Seamless phase II/III clinical trials combine traditional phases II and III into a single trial that...