| Study characteristics |
| Methods |
To examine the association between financial conflicts of interest among FDA Center for Drug Evaluation and Research advisory committee members and voting behavior. FDA drug advisory committee reports from February 1997 to December 2011 |
| Data |
379 advisory committee reports and 15,739 advisory committee members |
| Comparisons |
Adviosory committee members with financial conflicts of interest (defined as financial interests in the sponsoring firm, in a firm competing with the sponsor, or in both the sponsoring firm and any of its competitors) and advisory committee members without financial conflicts of interest |
| Outcomes |
Recommendations (favourable recommendations defined as votes favourable to the sponsoring firm) |
| Funding source |
The study was funded by the Edmond J. Safra Philanthropic Foundation and no additional funding related to any for‐profit organisation was disclosed |
| Declaration of conflicts of interest |
The authors disclosed no conflicts of interest related to any for‐profit organisation |
| Notes |
|
| Risk of bias |
| Item |
Authors' judgement |
Support for judgement |
| Adequate document inclusion process |
Yes |
Three research assistants assessed advisory committee reports for inclusion (according to personal correspondence with lead author) |
| Adequate coding of conflicts of interest |
Yes |
One research assistant extracted data and coded each advisory committee report. One author reviewed and audited all data (according to personal correspondence with lead author) |
| Adequate coding of recommendations |
Yes |
One research assistant coded the recommendations of each advisory committee report. One author reviewed and audited all data (according to personal correspondence with lead author) |
| Adequate dealing with confounding |
No |
Compared advisory committee reports of different drugs, used for different diseases, and held within a large time span |
