Major mismatch: 1 in 3 clinical trials reports inconsistent adverse events, researchers say

Arezu Sarvestani | MassDevice | 31 March 2014

A random sampling of clinical trials reported to the federal database found that 1 in 3 had inconsistencies in their adverse event outcomes when compared with reports made to peer-reviewed medical journals, researchers said.

Most discrepancies involved either entire omission of “serious” adverse events (SAE) or differences that would have made little difference to the “direction of risk” for the overall study. However, the bias tended to lean in favor of a more favorable representation of the therapy in question.

In general the studies reported higher rates of AEs on the federal site than were mentioned in medical publications. The researchers stopped short of determining whether the federal site or the medical journals ultimately had the more accurate figures, but said that was host to a “more comprehensive summary” of AEs.

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