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Statistics Seminar Series

Thursday, February 16, 2006 @ 11:30AM
Cullimore Hall, Room 611
New Jersey Institute of Technology

When the Data Speaks for Itself, Why Interrupt?

Jyotirmoy Dey, Ph.D

Schering-Plough Research Institute

Kenilworth, New Jersey

Abstract

In a recently concluded cancer clinical trial a new chemotherapy agent combined with radiotherapy was observed to provide unprecedented benefit, in terms of prolonged overall survival, to patients with newly diagnosed Glioblastoma Multiforme (GBM), the most aggressive and fatal form of malignant brain tumors. While the results are compelling, a scrutiny of every aspect of the trial and the data must be undertaken, especially in light of certain stances adopted by regulatory agencies in the US and EU.  This talk will focus on some atypical analyses that occurred as a result of such considerations to adequately assess but not distract from the essential clinical message.