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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):1422-1423; doi:10.1093/jnci/djm167
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Published by Oxford University Press 2007.

EDITORIALS

Early Average Change in Tumor Size in a Phase 2 Trial: Efficient Endpoint or False Promise?

Larry V. Rubinstein, Janet E. Dancey, Edward L. Korn, Malcolm A. Smith, John J. Wright

Affiliations of authors: Biometric Research Branch (LVR, ELK) and Cancer Therapy Evaluation Program (JED, MAS, JJW), National Cancer Institute, Bethesda, MD

Correspondence to: Larry V. Rubinstein, PhD, National Cancer Institute, National Institutes of Health, Biometric Research Branch, Executive Plaza North, Rm. 8130, MSC-7434, Bethesda, MD 20892-7434 (rubinsteinl@ctep.nci.nih.gov).

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

Advances in our understanding of tumor biology, in pharmaceutical development, and in imaging technology have led to vigorous discussions about the most appropriate designs and endpoints for phase 2 trials (1). The need for these discussions is occasioned in part by novel agents whose predominant effect is to delay tumor progression and new imaging technologies that have increased the accuracy with which tumor size can be assessed and have introduced new ways of assessing tumor metabolism, perfusion, and necrosis. Further grounds for reassessment of trial design is the fact that it has long been acknowledged that tumor objective response, as defined by traditional response criteria, may sometimes be a poor surrogate for predicting patient benefit.

The proposal by Karrison et al. (2) in this issue of the Journal is a novel and intriguing solution to some of the problems facing investigators designing phase 2 trials involving . . . [Full Text of this Article]


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J Natl Cancer Inst 2007 99: 1421. [Extract] [Full Text] [PDF]



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