For more information on adaptive designs in early-stage and late-stage clinical trials, see the list of case studies based on recent consulting and software development projects.
For more information on applications of advanced multiplicity adjustment methods, see the list of case studies based on confirmatory Phase III trials.
Subgroup analysis deals with evaluation of treatment effects in clinical trials with respect to the primary and key secondary endpoints in selected patient subgroups. The subgroups are defined based on baseline characteristics, including demographic, clinical, genetic and other variables.
Mediana Inc has successfully applied advanced methods of confirmatory subgroup analysis and exploratory subgroup analysis in late-stage clinical trials:
- Confirmatory subgroup analysis is performed in confirmatory Phase III trials with one or more prospectively defined subpopulations of patients that are more likely to benefit from the treatment than patients in the overall population. Analysis of the subgroups may result in a modified regulatory claim or additional regulatory claims.
- Exploratory subgroup analysis is commonly utilized in Phase III trials and relies on a post-hoc subgroup search. Exploratory subgroup analysis can be performed in Phase III trials with a positive efficacy signal in the overall patient population to evaluate the benefit-risk profile of multiple subgroups. Based on the results of these evaluations, a subgroup may be excluded from a trial if the treatment mainly benefits patients in the complementary subgroup. Alternatively, if safety issues are detected in the overall population, a subgroup with an acceptable safety profile can be selected. Similar analyses can be also performed in failed Phase III trials to help identify one or more subgroups with a beneficial effect.
For more information on applications of confirmatory and exploratory subgroup analysis methods in late-stage clinical trials, see the list of case studies based on recent consulting and software development projects.