Quality of Reporting of Bioequivalence Trials for Generic Drugs
Author Information
Author(s): van der Meersch Amélie, Dechartres Agnès, Ravaud Philippe
Primary Institution: INSERM, U738, Paris, France
Hypothesis
To assess the quality of reporting of bioequivalence trials comparing generic to brand-name drugs.
Conclusion
The quality of reporting of trials assessing generic drugs is often poor, with many important details missing.
Supporting Evidence
- 41% of articles reported the funding source, but only 25% were public.
- 94% of articles reported the type of statistical analysis used.
- Only 15% of articles adequately reported the randomization sequence generation method.
Takeaway
This study looked at how well reports of trials comparing generic and brand-name drugs are written. It found that many important details were often left out.
Methodology
The study involved a systematic review of bioequivalence trials published between January 2005 and December 2008, evaluating the reporting quality of 79 selected articles.
Potential Biases
Potential publication bias due to the predominance of positive trial results.
Limitations
The search period was limited to 2005-2008 and relied solely on PubMed, which may not have captured all relevant studies.
Participant Demographics
Most studies included healthy participants, with a median age of 28 years.
Statistical Information
Confidence Interval
90% confidence intervals for bioequivalence criteria were often not reported adequately.
Digital Object Identifier (DOI)
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