Abstract

The unprecedented pace of therapeutic development in oncology has created a climate in which the traditional methods of evaluating agent activity might no longer be adequate. How is the field transitioning to new endpoints in early drug development and what are the difficulties in this transition? Here, we will explore the historical context for the current criteria for tumour response evaluation and some of the pitfalls in using these standards when testing newer anticancer agents for activity. We will argue that the current drug development environment dictates different outcome measurements and therefore more imaginative and rigorous early-phase trial designs.

Author affiliations

1. Mark J. Ratain and Laura C. Michaelis are with the section of Hematology/Oncology at the University of Chicago, 5841 S. Maryland Avenue, MC 2115, Chicago, Illinois 60637, USA.

Correspondence to: Mark J. Ratain¹ Email: mratain@medicine.bsd.uchicago.edu

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