Reporting of Adverse Events in Published and Unpublished Studies of Health Care Interventions: A Systematic Review

open access

The median percentage of published documents with adverse events information was 46% compared to 95% in the corresponding unpublished documents. There was a similar pattern with unmatched studies, for which 43% of published studies contained adverse events information compared to 83% of unpublished studies.

Why Was This Study Done?

• Research on medical treatments provides information on the efficacy of such treatments, and on side effects.
• The balance between efficacy and side effects is important in assessing the overall benefit of a new treatment.
• How much information on the side effects of medical treatments that is currently not published in journal articles is not known.

What Do These Findings Mean?

• These findings suggest that researchers should search beyond journal publications for information on side effects of treatments.
• These findings also support the need for the drug industry to release full data on side effects so that a complete picture can be given to health professionals, policy makers, and patients.