Oncology Endpoints Training

A strong understanding of endpoints is foundational for clinical trial staff, because they are the measurements used to determine whether a clinical trial is a success. Developed by Merck, this course defines key endpoint concepts, with a particular focus on endpoints in oncology. The course is in three parts:

• Basic concepts and terms: objective vs endpoint vs hypothesis; primary/secondary/exploratory (and what’s co-primary vs dual primary, etc.), classical vs surrogate, objective vs subjective, composite, etc.; what kinds of things can be measured (physiological, cellular, molecular, imaging).
• Common oncology endpoints: OS, PFS, EFS, ORR, DOR, DCR, pathologic response, eCOA; what endpoints are used in what phases of development; what is the role of oncology response criteria (e.g. RECIST, Lugano, etc.)
• Other concepts associated with endpoints: high-level definitions and discussion of concepts like Kaplan-Meier curves, censoring, analysis population, etc.