Oncology Research Today is a free monthly online journal that collates and summarizes the latest research about Oncology, including details on cancer, surgery, chemotherapy, radiotherapy.

Use of progression-free survival as a surrogate marker in oncology trials: some regulatory issues.

Chakravarty A, Sridhara R

Office of Biostatistics, Center for Drug Evaluation and Research, FDA, MD, USA.

There has been interest in using progression-free survival as a surrogate endpoint for overall survival in oncology clinical trials. In order to objectively define this endpoint, clear understanding of what progression means, how it is measured and what its implications are need to be discussed. This article discusses some regulatory aspects of using progression-free survival as an endpoint.

Published 20 February 2008 in Stat Methods Med Res.
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