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.