Facilitating audits of clinical trial data using documents of the Food and Drug Administration

Abstract

The Medical Review document of the FDA is a rich source of data about clinical trials underlying the approval of a given drug. There are also other sources of information about clinical trials, such as trial registries and publications. However the data in the various sources may be erroneous or discrepant, and therefore there have been calls for audits of data in trial registries, in particular. The data in the Medical Review documents could be used as a source, to cross check data from other sources. However, it is extremely cumbersome to access the data in this document. We have analyzed the summary ‘Table of Clinical Studies’ of forty five Medical Reviews, and note significant differences in what information is presented in this table. We outline the details of an informative template Table, that would facilitate audits.