Correction: Reporting Bias in Drug Trials Submitted to the Food and Drug Administration: Review of Publication and Presentation
2009
Correction on Reporting Bias in Drug Trials
Sample size: 179
publication
Evidence: moderate
Author Information
Author(s): Kristin Rising, Peter Bacchetti, Lisa Bero
Conclusion
The correction identifies numerical errors in the reporting of outcomes and conclusions in drug trials submitted to the FDA.
Supporting Evidence
- Trials had a total of 179 primary outcomes reported in the NDAs.
- 41 primary outcomes from the NDAs were omitted from the papers.
- Papers included 138 outcomes that were also in the NDAs, plus additional outcomes favoring the test drug.
- 20 outcomes that did not favor the test drug were not included in the papers.
- 9 conclusions changed from the FDA review to favor the test drug.
Takeaway
This study found mistakes in how drug trial results were reported, which could make the drugs look better than they really are.
Limitations
The changes in outcomes and conclusions were too few to allow for a meaningful investigation of predictors.
Statistical Information
P-Value
p = 0.0039
Confidence Interval
95% CI 72% to 100%
Statistical Significance
p < 0.0001
Digital Object Identifier (DOI)
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