Study characteristics |
Methods |
To investigate whether financial ties to drug companies bias FDA drug advisory committee members’ voting on drug approval recommendations. FDA advisory committee meeting held between 1997 and 2012 |
Data |
416 advisory committee reports and 1483 advisory committee members |
Comparisons |
Advisory committee members with financial conflicts of interest (defined as financial ties to any drug company) and advisory committee members without financial conflicts of interest |
Outcomes |
Recommendations (favourable recommendations defined as votes in favour of the drug) |
Funding source |
The study received support from the Searle Civil Justice Institute and no additional funding related to any for‐profit organisation was disclosed |
Declaration of conflicts of interest |
Conflicts of interest not described |
Notes |
|
Risk of bias |
Item |
Authors' judgement |
Support for judgement |
Adequate document inclusion process |
Unclear |
Not possible to determine |
Adequate coding of conflicts of interest |
Unclear |
Not possible to determine |
Adequate coding of recommendations |
Unclear |
Not possible to determine |
Adequate dealing with confounding |
No |
Compared committee meetings of different drugs used for different diseases |