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February 18, 1983

Ethics of Phase I Clinical Trials

Author Affiliations

University of Tennessee Center for the Health Sciences Memphis

JAMA. 1983;249(7):883. doi:10.1001/jama.1983.03330310018011

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To the Editor.—  Dr Mortimer Lipsett's recent commentary on the ethics of phase I clinical trials fails to address adequately two key issues regarding the informed-consent process. First, Dr Lipsett's insistence that such trials have therapeutic intent is open to easy misunderstanding among potential subjects. In claiming "therapeutic intent," Dr Lipsett points out that drugs entering phase I testing have been found efficacious in animal models and that similar results are hoped for in human testing. However, the initial dosage used in human subjects is usually some fraction, eg, one third, of the minimum toxic dose in milligrams per square meter established with large animals. The prospect for therapeutic efficacy is exceedingly remote at this dosage and at the initial incremental dosages used with other early subjects. In addition, on a general statistical basis, the frequency of partial or complete responses to phase I agents is extremely low. Unless prospective