Other highlights in the Feb. 12 JNCI(r the current reporting system these sid...),Health

Maureen Edgerly and Tito Fojo, M.D., Ph.D., of the National Cancer Institute in Bethesda, Md., argue that revised criteria are needed for physicians and researchers to more accurately assess and report such adverse events. In particular, they suggest improvements for the classification and reporting of long-term side effects and those that affect a patients daily activities.

In an era when the number of me-too drugs (i.e., drugs that are structurally similar to known drugs) will likely increase, it will be important for clinical trials to accurately capture and report toxic effects if the FDA is to adhere to its mandate to approve drugs that are either more efficacious or with comparable activity but less toxicity that those already approved, the authors write. It is imperative that the reported data accurately reflect the long-term effects of a drug on physical functioning, quality of life, and tumor-related symptoms, in addition to its effects on disease-free survival.

Contact: National Cancer Institute press office, (301) 496-6641, ncipressofficers@mail.nih.gov

'/>"/>