Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples
Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples
Abstract Subgroup analyses are assessments of treatment effects based on certain patient characteristics out of the total study population and are important for interpretation of pivotal oncology trials. However, appropriate use of subgroup analyses results for regulatory decision-making and product labeling is challenging. Typically, drugs approved by the FDA are …