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Blog Post
Clinical Trial Analysis Considerations for a Post-Hoc Overall Survival Endpoint
When analyzing overall survival in a post-hoc manner sponsors need to carefully consider the types of analyses to present and have a thorough understanding of both the regulatory precedent and market landscape which their product will enter.
Blog Post
How to Place Overall Survival Results into a Proper Benefit-Risk Framework
Overall survival (OS) is both an important efficacy & safety endpoint for oncology trials. Often when study results are submitted for regulatory consideration, OS results are often “immature”/still in their early stages which makes them difficult to evaluate. Understanding how to place these results into a proper benefit-risk framework for consideration is therefore important when assessing a potential treatment’s viability.
Blog Post
Statistical Design Considerations for Dose-Finding Oncology Trials
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.
Blog Post
Ensuring Successful Enrollment in Oncology Dose Escalation Trials
Oncology dose-escalation trials are a distinct entity, with nuances and considerations which set them apart from other therapeutic areas. From varying trial designs to the patients who participate, dose-finding clinical trials in oncology are a clinical research paradigm. Understanding strategies to facilitate success is key to study planning and execution, from feasibility to site selection through enrollment and treatment.