© 2004 by Oxford University Press
© 2004 Oxford University Press
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For Phase I Studies, Ethical and Practical Concerns Abound
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For researchers who conduct clinical trials, phase I studies are a hard sell: The drug or therapy is being tested in humans for the first time, the study has no hypothesis to test, and none of the accepted goals include a benefit to the patient. Instead, patients are asked to be willing participants in research that mayor may nothelp cancer patients in the future.
"The history of human experimentation can be traced back as long as
the history of medicine," said Neil Abramson, M.D., of the Baptist
Cancer Institute in Jacksonville, Fla., who chaired a symposium on the
practical and ethical issues of phase I research at this year's annual meeting
of the American Society of Clinical Oncology (ASCO). "When is it right
to experiment
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J Natl Cancer Inst 2004 96: 1355.