How to access and process FDA drug approval packages for use in research

Reporting bias leads to an overestimation of drug efficacy and underestimation of drug harms, but its effects can be mitigated by using unpublished data from drug regulatory agencies. Such data can be useful to clinicians interested in going beyond the product labelling and published literature. By comparing drug regulatory data with the published literature, researchers can uncover reporting bias, and researchers have been advised to use such data in systematic reviews 1 and meta-analyses. Unlike, the EMA, the US Food and Drug Administration does not make individual patient data available. However, drug approval packages, also referred to as reviews or summary basis of approval documents, have been available on the FDA website since 1997. 6 7 These are filtered summaries of clinical study reports and related documents, written by FDA staff, who may review "pivotal trials" in more depth than other trials.