ABSTRACT
The unmet need and urgency underpinning oncology drug development have put many new innovations in statistical methodology front and center. The emergence of more sophisticated imaging modalities and new biomarkers resulting from a more granular understanding of cancer at the molecular level has created tremendous opportunities to further expedite the development of new cancer therapeutics. As more and more effective therapies become available across many tumor types, overall survival (OS) is becoming an increasingly difficult endpoint to study. Long OS times and confounding of results from effective post-progression therapies have greatly complicated the ability to design trials with OS as a primary objective. The endpoints and associated trial designs in oncology have been responsible for many successful development programs in oncology, but often times registration has not been with the optimal dose regimen. Dose selection remains a critical challenge in the development of new oncology therapeutics.
