In a helpful new development, FDA has updated its inspection classification dataset by adding inspection type categories (e.g., Sponsor, IRB, Investigator) to all its Bioresearch Monitoring inspection data. These data can be found in the Additional Details column of the downloaded data set, which is also available as a live filter on FDA's inspection dashboard. 

Previously, our team had attempted to categorize these data based on the inspectee name, but it was not always possible to differentiate between inspection types using this information - for example, an inspection of a commercial-stage sponsor might be a PV or clinical trial inspection. Although other project areas are not fully categorized, the Bioresearch Monitoring project area inspection data appears to be complete, giving us unprecedented visibility into GCP inspections. Let's take a look!

First, some summary data. 

FDA's Bioresearch Monitoring group conducts more Clinical Investigator inspections than all other types put together, with IRB inspections a distant second and Sponsor/CRO inspections third.

Narrowing in on the top five categories, we see a dramatic drop for clinical site inspections at the start of the pandemic, with continued flattening in all categories through FY2022 (OCT-2021 through SEP-2022) except for IRBs. 

Finally, looking at inspection classifications, we see that Bioanalytical BA/BE inspections and Sponsor-Investigator inspections (where the investigator is also the sponsor) are most likely to generate "Official Action Indicated (OAI)" outcomes, while no PADE inspections since FY 2018 have been classified as OAI.  PADE inspections, however, are more likely to generate VAI outcomes than most other categories.

FDA's dashboard allows you to create charts and graphs on the fly, but the filters sometimes reset when no results are returned, so we find it easier to download the whole data set and build our pie and bar charts from there.