On the Use of Change in Tumor Size to Predict Survival in Clinical Oncology Studies: Toward a New Paradigm to Design and Evaluate Phase 2 Studies

Drug-independent models that link biomarker response to clinical end points are critical to support early (end of phase II) clinical decisions. In oncology, change in tumor size (a biomarker of drug effect evaluated in phase II) is linked to survival (a phase III end point) in some solid tumors.