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Previous Volume 352:2451-2453 June 9, 2005 Number 23 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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To the Editor: Horstmann et al. (March 3 issue)¹ assume that a tumor response is of benefit to subjects in phase 1 oncology trials. This assumption is not valid. A complete or partial tumor response in a phase 1 trial is a surrogate end point, which for most agents has not been linked to a clinically meaningful outcome, such as improved survival.²

Informing subjects that they have a 10.6 percent chance of a tumor response is potentially misleading unless accompanied by an explicit discussion of clinical end points and whether any connection exists between a tumor response and clinical end . . . [Full Text of this Article]

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