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Crucial Pediatric Drug Trial Safety Data Often Ignored

Many trials go unpublished, and published ones often do not highlight safety data

TUESDAY, Dec. 8 (HealthDay News) -- Important safety data from pediatric drug trials often go unpublished, and articles that are published do not focus on adverse events and labeling changes, according to a study in the December issue of the Archives of Pediatrics & Adolescent Medicine.

Daniel K. Benjamin Jr., M.D., of Duke University in Durham, N.C., and colleagues reviewed 365 trials for 153 drugs derived from U.S. Food and Drug Administration records and a database of peer-reviewed literature.

When the researchers evaluated 129 of the 137 labeling changes, they found that 33 (26 percent) of the products had added pediatric safety information to the labeling, 12 relating to neuropsychiatric findings and 21 to other safety issues. However, of these 33, only 16 (48 percent) of them had been published, and seven of these did not highlight the FDA reviews and labeling changes.

"We and others have shown a low incidence of publication, and we have previously provided evidence that if data are not published within three years of being submitted to the FDA, they are unlikely to ever be published," the authors write. "It might be proposed that all data collected during these trials and submitted to the FDA also be submitted in a public manner similar to the approach provided for the off-patent studies that are conducted under the second mechanism."

Several study authors reported financial ties to pharmaceutical companies.

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