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Journal of the National Cancer Institute Advance Access originally published online on January 29, 2008
JNCI Journal of the National Cancer Institute 2008 100(3):164-166; doi:10.1093/jnci/djn006
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© Oxford University Press 2008.

NEWS

Examining Heterogeneity in Phase II Trial Designs May Improve Success in Phase III

Rabiya S. Tuma

The first 150 words of the full text of this article appear below.

The failure rate for late-stage clinical trials in oncology is higher than that for any other area of medicine. Between 1991 and 2000, for example, 55% of phase III trials in oncology failed, compared with 30% in infectious disease and 20% in cardiology, according to a study by Schering-Plough and Merck investigators. A separate study from researchers at Princess Margaret Hospital in Toronto estimated that between 1998 and 2003, 85% of the phase III trials that tested new therapies for solid tumors failed to meet their primary endpoint.

Although many factors contribute to this relatively low success rate in oncology, some experts suggest that a key problem is the tendency of researchers to ignore patient and tumor characteristics in phase II trials.

"Human beings are very heterogeneous, but for some strange reason when people design clinical trials they act as if people are peas in a pod," said Peter Thall, . . . [Full Text of this Article]

Randomized Phase II Trials

Creative Designs


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