How to use FDA drug approval documents for evidence synthesesBMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k2815 (Published 10 July 2018) Cite this as: BMJ 2018;362:k2815
All rapid responses
The recent paper “How to use FDA drug approval documents for evidence syntheses”  aims to provide methodology guidance using FDA documents to improve evidence syntheses. As part of the BMJ audience, we thank the authors for their work. In the introduction section, Aviv Ladanie et al pointed that when an evidence synthesis is conducted, it includes all of the studies on the topic, including unpublished studies and omitted data in published studies. But, we are concerned about these actions.
First, data in unpublished studies are not peer-reviewed and the quality of data may not be so true--that is, some mistakes maybe existed. Using these data to produce evidence may lead to wrong results or decreased effect size. The phenomenon will result in exposure of patients to inadequate treatment and waste limited resources, including brain power, time and material.
Second, for ordinary researchers, having to ask for omitted raw data from the authors of related studies is always difficult. In our opinion, third methods may be effective. First, researchers should not be afraid of being blamed for limitations or mistakes in their papers or reports: we should know that science allows mistakes. The Chinese proverb “To err is human” is the best illustration. Second, registry and published protocol will guarantee complete data process. Third, data sharing will ensure all studies can be identified.
Conflicts of interest
We declare that we have no conflicts of interest.
1. Aviv Ladanie, Hannah Ewald, Benjamin Kasenda, Lars G Hemkens. How to use FDA drug approval documents for evidence syntheses. BMJ 2018;362: k2815
Competing interests: No competing interests