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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.
Lipsett MB. Ethics of Phase I Clinical Trials-Reply. JAMA. 1983;249(7):883. doi:10.1001/jama.1983.03330310018012
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