The selection of clinical endpoints when designing a clinical trial is critically important to ensure appropriate evaluation of the agent or regimen of interest. Endpoints in early stage clinical trials differ from those in later stage trials, and the nature of the endpoints (e.g., continuou,s categorical) has an impact on both the parameters that can be estimated and the power to detect significant differences. This talk will focus on the selection of continuous (e.g. Ki67, breast density, change in tumor size), categorical (e.g. RECIST response, pathologic complete response), and time to event endpoints (e.g. progression-free survival, overall survival) when designing clinical trials. Discussion will also include interpretation of resulting measures of clinical efficacy (e.g. hazard ratios), approaches for stating trial objectives and implications of endpoint selection on statistical power.

Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr ES03-3.