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. 2020 Dec 8;2020(12):MR000040. doi: 10.1002/14651858.MR000040.pub3

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