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Imatinib: a study in the quality of adverse events reporting
Community Oncology , 10/09/09

Samaras AT et al. – This is the first study ever reported that compares the quality of clinical trial adverse event reports submitted to the FDA, IRBs, and the pharmaceutical manufacturer with the quality of information that could be developed using structured case report forms. The study found that the reports of sADEs submitted to IRBs, the FDA, and the pharmaceutical manufacturer were markedly less complete and less accurate than reports associated with the same clinical events that were derived with the assistance of structured case report forms. Increased use of structured, syndrome–specific case report forms may ultimately help improve drug safety for cancer patients.

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