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December 8, 1993

Data Audit for Clinical Trials-Reply

JAMA. 1993;270(22):2685. doi:10.1001/jama.1993.03510220041026

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In Reply.  —Some of the Cancer and Leukemia Group B studies do prohibit use of certain concurrent medications. These prohibitions are usually limited to corticosteroids in such malignancies as myeloma, breast carcinoma, and lymphomas. Dr Wilson asks if our audit process critiques protocol deviations where a prohibited drug is given anyway. The answer is, "Yes indeed," and when this occurs, it is coded as a major deviation. This deviation occurs most often in use of dexamethasone as an antiemetic to be administered with chemotherapy. There are a number of such additional issues that could have been evaluated in our analysis of the audit reports generated during the past 11 years. However, we chose to assess those protocol deviations and administrative deficiencies that we thought were particularly important. Although I cannot provide Wilson with a precise figure of how often this sort of protocol deviation occurs, a reasonable estimate is something