Oncology

Analyses conducted using the overall population can mask the extent of the benefit-risk in subgroups of patients.  Thus, subgroup analyses are critical to fully understand the benefit-risk in pivotal oncology trials and guide regulatory decisions for approval and labelling.  However, subgroup analyses also present several challenges especially for overall survival (OS) where larger sample sizes and longer follow-up are needed, and where early analyses of immature data may be conducted.

Since the introduction of the original 3+3 method, the available design options for dose escalation in early phase studies have expanded beyond traditional algorithm-based designs to include model-based designs.