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JNCI Journal of the National Cancer Institute 2000 92(12):1011-1013; doi:10.1093/jnci/92.12.1011
© 2000 by Oxford University Press
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Journal of the National Cancer Institute, Vol. 92, No. 12, 1011-1013, June 21, 2000
© 2000 Oxford University Press

BRIEF COMMUNICATION

Rapid Reporting and Review of an Increased Incidence of a Known Adverse Event

Daniel J. Sargent, Richard M. Goldberg, Michelle R. Mahoney, David W. Hillman, Timothy McKeough, Sonja F. Hamilton, Jennifer M. Darcy, Victoria L. Anderson, James E. Krook, Michael J. O'Connell

Affiliations of authors: D. J. Sargent, R. M. Goldberg, M. R. Mahoney, D. W. Hillman, T. McKeough, S. F. Hamilton, J. M. Darcy, V. L. Anderson, M. J. O'Connell, Mayo Clinic and Mayo Foundation, Rochester, MN; J. E. Krook, Duluth Community Clinical Oncology Program, MN.

Correspondence to: Daniel J. Sargent, Ph.D., Mayo Clinic, 200 First St., S.W., Rochester, MN 55905 (e-mail: sargent.daniel@mayo.edu).

The National Cancer Institute (NCI) sponsors cancer clinical trials throughout the United States. Many of these trials are conducted by one of the groups of investigators that participate in the nine adult cancer cooperative groups (CCGs). CCGs typically have a single operations office and a single statistical office. Primarily, CCGs perform clinical trials to advance the treatment of cancer. In every trial, patient safety is of paramount importance. CCG investigators are required by the NCI to report some or all adverse events. An adverse event is defined by the U.S. Food and Drug Administration (FDA) as "any undesirable experience associated with the use of a medical product in a patient" (1). On the basis of the NCI Common Toxicity Criteria (2), each adverse event is graded on a 5-point severity scale: 1 = mild, 2 = moderate, 3 . . . [Full Text of this Article]

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