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Preparing for Clinical Trial Data Audits

Because this article has no abstract, we have provided an extract of the first 100 words of the full text.

In the mid-1950s, the National Cancer Institute (NCI; Bethesda, Maryland) began funding the Cooperative Group Program. Throughout the next 25 years, there was no on-site verification of protocol compliance and validation of the data submitted by participating members of these cooperative groups. In contrast, the US Food and Drug Administration (FDA; Washington, DC) required that pharmaceutical companies perform on-site validation of the clinical trial data involving testing of investigational new drugs. In 1979, it was discovered that scientific fraud had occurred at one institution¹ that was a prominent member of a major NCI-funded cooperative group. As a result of that . . . [Click for More]