Ethics of Phase I Clinical Trials

Alexander M. Capron
JAMA. 1983;249(7):882-883. doi:10.1001/jama.1983.03330310018010.
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To the Editor.—  Dr Mortimer Lipsett's sensitive and balanced commentary entitled "On the Nature and Ethics of Phase I Clinical Trials of Cancer Chemotherapies" (1982;248:941) provides a valuable reminder of the need to avoid both manipulating patients with cancer into participation in clinical trials and "overprotecting" them from the opportunity, by contributing to future cures, to give meaning to what is otherwise a personal tragedy.Dr Lipsett seems to be of two minds, however, regarding the purpose of the phase I trials. He begins his description by stating: "First, there is always therapeutic intent" and then describes the additional purposes (determining dosage schedule, toxic effects, and pharmacokinetics). A different emphasis emerges later in the article when Dr Lipsett describes the consent process for trials of anticancer drugs at the National Institutes of Health (NIH) Clinical Center, Bethesda, Md. There, patients are told that "the chief purpose" of such studies is


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