FDA Clinical Investigator Inspection List, who is Inspected and What are the Results for Countries Outside US?

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Bjarne Madsen Härdig, RN, PhD Pyotr G Platonov, MD, PhD


Background: The purpose of this analysis was to revisit the open US Food and Drug Administration (FDA) inspection list results from clinical trials and show the possibilities of evaluating inspection results between different world regions and explore what aspects of clinical trial deficiencies are most often reported.

Aims: The aim of this study was to evaluate inspection results from different regions of the world and the deficiencies most often reported.

Methods: On October 10, 2021, the clinical Investigator Inspection List was download as an Excel spreadsheet (Microsoft, Seattle, USA) from the FDA homepage. Data were extracted and categorized as: Number of inspections in each region and country, number and % of actions found during the inspections, number and % of deficiencies found – in total and in the different regions and countries. No statistical comparison was made on the analysed data in the article.

Results: The total number of inspections performed by the FDA outside the US between 1980 and October 2021 was 3,222. The number of voluntary actions varies in the same manner as the number of inspections. The number of “no actions indicated” increased after 1994, which may indicate that adding new and smaller countries to participate in clinical trials does not affect the quality of the clinical trials. The results shows that most common action registered by the FDA was “voluntary actions indicated (VAI)” (56.6%) followed by “no action indicated (NAI)” (38.6%), while “official action indicated (OAI)” were rare (4.1%). “VAI” and “NAI” were registered in all regions. "VAI” were indicated for topics related to documentation and reporting in 787 inspections (24.4%), protocol violation in 683 inspections (21.2%)), informed consent/institutional review board in 257 inspections (8.0%). The same type of deficiencies was noted for “OAI”; however, these were significantly rarer.

Conclusion: The US Food and Drug Administration only monitors a small number of all clinical trials performed worldwide (1.3%). Despite the large difference in the number of FDA inspections performed in different regions worldwide, the structure of inspection findings is remarkably similar across the globe.

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How to Cite
HÄRDIG, Bjarne Madsen; PLATONOV, Pyotr G. FDA Clinical Investigator Inspection List, who is Inspected and What are the Results for Countries Outside US?. Medical Research Archives, [S.l.], v. 10, n. 11, nov. 2022. ISSN 2375-1924. Available at: <https://esmed.org/MRA/mra/article/view/3303>. Date accessed: 17 june 2024. doi: https://doi.org/10.18103/mra.v10i11.3303.
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