Case studies: Subgroup analysis
Confirmatory subgroup analysis methods enable the trial’s sponsor to assess the efficacy and safety profiles of novel treatments in multi-population settings, i.e., in trials where one or more patient subpopulations are prospectively defined in addition to the overall population of patients. An important feature of these methods is that they ensure logically consistent and clinical meaningful conclusions (using the influence and interaction conditions). In particular, Mediana has developed confirmatory subgroup analysis strategies in adaptive Phase III trials with biomarker-driven designs.
For information on the application of confirmatory subgroup analysis methods in adaptive trials and related custom software tools, see the case studies with adaptive population selection designs page.
Exploratory subgroup analysis methods, also known as subgroup identification methods, are commonly employed in failed clinical trials with a negative outcome in the overall population of patients. Subgroup identification methods help trial sponsors efficiently explore treatment effects in subsets of the overall population with the goal of identifying a subgroup of patients who experience beneficial treatment effect. Mediana has developed and applied powerful subgroup identification methods, e.g, the SIDES method, to perform subgroup searches using a set of candidate biomarkers in several failed Phase III trials, including several oncology trials and, more recently, a trial for the treatment of benign prostate hypertrophy.
For information on the custom software tools developed to support efficient subgroup search strategies in these Phase III trials, see the custom software page.