Bias and Misreporting in Clinical Trials
Author Information
Author(s): An-Wen Chan
Primary Institution: Mayo Clinic
Hypothesis
Is the randomized trial literature biased towards reporting favorable results?
Conclusion
The study found that a significant portion of trial data submitted to the FDA is missing from published literature, particularly unfavorable results.
Supporting Evidence
- One quarter of trials in the sample were unpublished, mainly those with unfavorable results.
- An additional quarter of primary outcomes were omitted from published trial articles.
- Discrepancies favored the sponsor's new drug, indicating biased reporting.
Takeaway
Sometimes, when doctors look at studies about new medicines, they only see the good results and not the bad ones, which can be confusing.
Methodology
The study compared trial data from FDA submissions with published journal articles to identify discrepancies.
Potential Biases
There is a risk of biased reporting due to selective publication of positive results.
Limitations
The study may not cover all types of trials, particularly those without regulatory oversight.
Digital Object Identifier (DOI)
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