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Researchers underreport drug safety problems

Researchers conducting randomized controlled trials (RCTs)—the gold standard for evaluating medications—appear to largely underreport or even neglect to report problems involving drug safety, according to a recent study supported by the Agency for Healthcare Research and Quality (HS10345). They found that, on average, medical journal articles about drug trials devote only about one-third of a page to safety information—such as side effects of medications and the frequency and reasons for patient withdrawals from drug studies—roughly the same space they devote to naming the contributors and their affiliations.

According to the study's authors, John P.A. Ioannidis, M.D., of Tufts University School of Medicine and Greece's University of Ioannina School of Medicine, and Joseph Lau, M.D., of the New England Medical Center, the quality of safety reporting also appears to be inadequate. The researchers examined safety reporting in 192 randomized drugs trials, each involving a minimum of 100 patients and at least 50 patients in each study arm. More than 130,000 trial subjects were involved overall. The trials involved testing of medications for seven treatment areas: HIV therapy; antibiotic therapy for acute sinusitis; thrombolysis (clot dissolving drugs) for heart attack patients; nonsteroidal antiinflammatory drugs for rheumatoid arthritis; high blood pressure treatment in the elderly; antibiotic treatment of Helicobacter pylori, a major cause of stomach ulcers; and selective decontamination of the gastrointestinal tract.

The severity of medication side effects and drug toxicity revealed by abnormal laboratory test results was adequately explained in only 39 percent and 29 percent, respectively, of drug trial reports, and a further 11 percent and 8 percent of trials had partial reporting of side effects and drug toxicity. Also, while the numbers of patients in each trial study arm who had to be withdrawn because of drug toxicity were cited in 75 percent of trial reports, the specific reasons for these discontinuations were given only 46 percent of the time.

According to the authors, major strides have been made in standardizing the collection, analysis, and reporting of efficacy data in clinical trials, but efforts to evaluate and improve the quality of analysis and reporting of safety data lag behind.

For more information, see "Completeness of safety reporting in randomized trials: An evaluation of 7 medical areas," by Drs. Ioannidis and Lau, in the January 24/31, 2001 Journal of the American Medical Association 285(4), pp. 437-443.

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