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John R. Wilson, Jr, PhD
Boehringer Ingelheim Pharmaceuticals Inc Ridgefield, Conn

JAMA. 1993;270(22):2685.

	Since this article does not have an abstract, we have provided the first 150 words of the full text PDF and any section headings.

To the Editor.

—Weiss et al¹ describe the audits of the Cancer and Leukemia Group B. These data audits, which focus on "protocol eligibility, pretreatment evaluation, treatment, and response assessment," are certainly comprehensive. However, one notices the absence of any reference to audit data on concomitant medications administered to trial subjects. While many different concomitant medications are certainly allowable in most protocols, there is always the possibility of the introduction of an interfering medication, or one that clouds the reliability of the data. The administration of an interfering concomitant medication is usually classified as a major protocol violation. Since inappropriate concomitant medication can have an adverse effect on the reliability of a given subject's trial data, and indeed of the entire clinical trial, such should ideally be considered in any audit plan. . . . [Full Text PDF of this Article]

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