As trials increase in complexity and scope, there is a requirement for trial designs to reflect this.
From dealing with non-proportional hazards in survival analysis to dealing with cluster randomization, we examine how to deal with study design issues of complex trials.
Non-proportional Hazards
Non-proportional hazards and complex survival curves have become of increasing interest, due to being commonly seen in immunotherapy development. This has led to interest in assessing the robustness of standard methods and alternative methods that better adapt to deviations.
In this webinar, we look at methods proposed for complex survival curves and the weighted log-rank test as a candidate model to deal with a delayed survival effect.
Cluster Randomization
Cluster-randomized designs are often adopted when there is a high risk of contamination if cluster members were randomized individually. Stepped-wedge designs are useful in cases where it is difficult to apply a particular treatment to half of the clusters at the same time.
In this webinar, we introduce cluster randomization and stepped-wedge designs to provide an insight into the requirements of more complex randomization schedules.
Three Armed Trials
Non-inferiority testing is a common hypothesis test in the development of generic medicine and medical devices. The most common design compares the proposed non-inferior treatment to the standard treatment alone but this leaves uncertain if the treatment effect is the same as from previous studies. This “assay sensitivity” problem can be resolved by using a three arm trial which includes placebo alongside the new and reference treatments for direct comparison.
In this webinar we show a complete testing approach to this gold standard design and how to find the appropriate allocation and sample size for this study.
Speaker: Ronan Fitzpatrick, Head of Statistics, Statsols
About Our Host
Ronan Fitzpatrick
Ronan Fitzpatrick is Head of Statistics at Statsols and the Lead Researcher for nQuery.
He has been a guest lecturer for many institutions including the FDA.