The manuscripts that comprise this supplement "Defining Clinical Endpoints in Renal Cell Carcinoma" are presented by six leading international clinical and basic investigators, and are derived from their presentations at the roundtable discussion, "Defining Clinical Endpoints in Renal Cell Carcinoma," which took place in Chicago on October 21, 2005, sponsored by Bayer HealthCare. It was given in conjunction with the Fourth International Kidney Cancer Symposium, and featured educational colloquia in lectures, case study presentations, and panel discussions that covered statistical hierarchy in clinical trial endpoints; historic data and endpoints for targeted therapy in various tumor types; clinical trial data with targeted agents and surrogate endpoints in renal cell carcinoma; and treatment in the community.
The faculty presented information on clinical trends and the design of future trials with historic, current, and promising regimens in renal cell carcinoma. Moreover, they proposed a surrogate endpoint (eg, progression-free survival) and tool for early response evaluation based on biologic efficacy (eg, tumor shrinkage). Finally, an additional goal was to produce enduring material for investigators to aid them in current and future study.
The material contained in this volume is thus intended to be a thorough, objective, balanced presentation of clinically oriented research in renal cell carcinoma. I hope that you, the reader, find the information to be timely, pertinent, and useful in patient management in both the community and trial setting, as well as in the design of future clinical trials.
Ronald M. Bukowski, MD