[Skip to Content]
[Skip to Content Landing]
Article
February 18, 1983

Ethics of Phase I Clinical Trials-Reply

Author Affiliations

National Institute of Child Health and Human Development Bethesda, Md

JAMA. 1983;249(7):883. doi:10.1001/jama.1983.03330310018012

This article is only available in the PDF format. Download the PDF to view the article, as well as its associated figures and tables.

Abstract

In Reply.—  Both respondents have correctly pointed out that the chief reason for a phase I trial is not therapeutic. I stated that, "First, there is always therapeutic intent" to emphasize this possibility, because some have incorrectly assumed in the past that such does not exist. I agree with Dr Ackerman that my assumption that current safeguards as listed are "generally sufficient" is just that—an assumption. Clinical investigators would welcome any further studies of the process of informed consent, particularly in the difficult situation of phase I trials of cancer chemotherapies.

×