Being “Safe” Still Isn’t Cool (30 Oct 2009)
Joseph Ross, MD, MHSIf we are to detect harms early and protect the public’s health while ensuring the availability of effective new therapies, systematic reporting of safety outcomes from all clinical trials must be available. In the current Archives of Internal Medicine, Isabelle Pitrou and colleagues (FREE) review the reporting of safety data in randomized, controlled trials published during 2006 in the major journals. Their findings are disappointing but not unexpected. Adverse events were unreported in 11% of 133 articles. Most seriously, data on severe adverse events or adverse-event-prompted study withdrawal were missing in… Continue Reading