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Journal of the National Cancer Institute Advance Access originally published online on September 25, 2007
JNCI Journal of the National Cancer Institute 2007 99(19):1428-1429; doi:10.1093/jnci/djm182
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© Oxford University Press 2007.

NEWS

Newer Phase II Trial Designs Gaining Ground

Steve Benowitz

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

The onrush of newer targeted therapies aimed at halting cancer growth rather than shrinking tumors has altered the oncology drug landscape. This change has also helped usher in a new view of cancer drug testing and development. Because these drugs work differently from standard chemotherapy agents, clinical trial designs often have had to evolve to reflect such differences, as well as take into account new drug combinations.

Add another impetus for change: Only about 5% of all new cancer drugs make it through to U.S. Food and Drug Administration approval, and traditional clinical trial strategies are coming under increasing scrutiny.

Take, for example, the phase II cancer drug clinical trial—the crucial "go" or "no go" midpoint of drug development designed to test an agent's effectiveness against cancer. Many people involved in trial design see it as one place that cancer drug development could make some substantial changes for the better.

. . . [Full Text of this Article]

New Drugs, New Paradigm

Innovations Needed

Critics and Downsides


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Related Article in JNCI

Design of Phase II Cancer Trials Using a Continuous Endpoint of Change in Tumor Size: Application to a Study of Sorafenib and Erlotinib in Non–Small-Cell Lung Cancer
Theodore G. Karrison, Michael L. Maitland, Walter M. Stadler, and Mark J. Ratain
J Natl Cancer Inst 2007 99: 1455-1461. [Abstract] [Full Text] [PDF]