Zhang 2019.
Study characteristics | ||
Methods | To understand how the FDA interprets the recommendations of its advisory committees and to explore potential contributing factors to cases in which the FDA as an agency disagreed with its advisory committees’ recommendations. FDA advisory committee meetings held between 2008 and 2015 | |
Data | 376 advisory committee reports | |
Comparisons | Advisory committee reports with financial conflicts of interest (defined as at least one committee members with financial ties to the drug manufacturer or competitor) and advisory committee reports without financial conflicts of interest | |
Outcomes | Recommendations (favourable recommendations defined committee votes in favour of the drug) | |
Funding source | No funding was received for the study | |
Declaration of conflicts of interest | JSR (last author) has received support from Johnson and Johnson to develop methods of clinical trial data sharing and from Medtronic to develop methods for postmarket surveillance of medical devices | |
Notes | ||
Risk of bias | ||
Item | Authors' judgement | Support for judgement |
Adequate document inclusion process | Yes | Two authors developed inclusion criteria, one author primarily assessed committee reports for inclusion, any uncertainties were discussed between two authors (according to personal correspondence with corresponding author) |
Adequate coding of conflicts of interest | Yes | One author primarily coded conflicts of interest for each committee report, any uncertainties were discussed between two authors (according to personal correspondence with corresponding author) |
Adequate coding of recommendations | Yes | One author primarily coded recommendations for each committee report, any uncertainties were discussed between two authors (according to personal correspondence with corresponding author) |
Adequate dealing with confounding | No | Compared committee meetings of different drugs and devices |
FDA: Food and Drug Administration