Late adverse event reporting from medical device manufacturers to the US Food and Drug Administration: cross sectional study

For research papers The BMJ has fully open peer review. This means that accepted research papers published from early 2015 onwards usually have their prepublication history posted alongside them on bmj.com.

This prepublication history comprises all previous versions of the manuscript, the study protocol (submitting the protocol is mandatory for all clinical trials and encouraged for all other studies at The BMJ), the report from the manuscript committee meeting, the reviewers’ comments, and the authors’ responses to all the comments from reviewers and editors.

In rare instances we determine after careful consideration that we should not make certain portions of the prepublication record publicly available. For example, in cases of stigmatised illnesses we seek to protect the confidentiality of reviewers who have these illnesses. In other instances there may be legal or regulatory considerations that make it inadvisable or impermissible to make available certain parts of the prepublication record.

In all instances in which we have determined that elements of the prepublication record should not be made publicly available, we expect that authors will respect these decisions and also will not share this information.