Valid assessment of drug efficacy and safety requires an evidence base free of reporting bias. Using trial reports in Food and Drug Administration (FDA) drug approval packages as a gold standard, researchers, Turner, Cipriani, Furukawa, et al. previously found that the published literature inflated the apparent efficacy of antidepressant drugs. The objective of the current study was to determine whether this has improved with recently approved drugs.
The authors concluded that Reporting bias persists but appears to have diminished for newer, compared to older, antidepressants. Continued efforts are needed to further improve transparency in the scientific literature.
Using FDA reviews on 4 newer antidepressants, we identified 30 trials, half with positive, and half with negative, outcomes. Among the 15 negative trials, 6 were unpublished and 2 others were misreported as positive. Seven other negative trials (47%) were reported transparently (as negative), an improvement over the low (11%) rate found earlier with the older antidepressants. Statistical comparison of the newer and older drug datasets indicated that transparent reporting had improved overall, mainly among negative trials. Yet compared to positive trials, the rate of transparent reporting for negative trials remains low. Using meta-analysis to compare drug efficacy based on FDA versus published data, we found less inflation of drug efficacy among newer, compared to older, antidepressants.
- Published: January 19, 2022
- https://doi.org/10.1371/journal.pmed.1003886
Leave A Comment