Clinical advances in hematology & oncology : H&O
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Clin Adv Hematol Oncol · Dec 2005
Review Retracted PublicationSome ethical issues in phase II trials in acute leukemia.
This paper addresses several scientific and ethical issues that arise in the design and conduct of phase II clinical trials of experimental therapies. Although we discuss chemotherapy trials in acute leukemia, the issues pertain to a much larger class of early-phase clinical trials. ⋯ We show that statistical designs that target inappropriately low response rates or that apply early stopping rules too infrequently are at odds with good statistical and medical practice and that such designs often provide less benefit to the patients in the trial than would be obtained by simply treating all patients with standard therapy. The general conclusions are that statistical designs have both scientific and ethical implications, and that science, statistics, and ethics cannot be treated as separate issues.