JAMA study slams trial safety reports

A study of drug trials covering seven major therapeutic categories hasfailed to produce a single example of "satisfactory" safety reporting, according to a report published in the January 23 issue of the Journal of the American Medical Association (2001;285:437-443).

The study, conducted by John Ionnidis of Tufts University School of Medicine and Joseph Lau of the New England Medical Center, examined a total of 192 drug trials, each of which had enrolled no fewer than 100 patients. They found that only 39% of the studies had reported the trialled drug's adverse effects adequately and, while 75% of the reports had noted the number of patients who withdrew from the study as a result of the product's toxicity, only 46% gave the specific reasons for their withdrawal.

The authors also comment that, despite the enormous amounts of safety and adverse-effects data collected by most high-quality trials, medical journals typically devote only one-third of a page to safety information. This is equal to the space which journals typically give to listing contributors' names and affiliations, they say.