Why (not) go east? Comparison of findings from FDA Investigational New Drug study site inspections performed in Central and Eastern Europe with results from the USA, Western Europe, and other parts of the world.

Drug Design, Development and Therapy
Paul H CaldronSiegfried Kropf

Abstract

Since the mid-1990s, investigational sites in the countries of Central and Eastern Europe (CEE) have been increasingly utilized by pharmaceutical companies because of their high productivity in terms of patient enrolment into clinical trials. Based on the FDA's publicly accessible Clinical Investigator Inspection List, we present an analysis of findings and outcome classifications from FDA inspections during Investigational New Drug (IND) studies and compare the results for the CEE region to those from Western European countries and the USA. Data from all 5531 FDA clinical trials inspections that occurred between 1994 (when the FDA first performed inspections in CEE) and the end of 2010 were entered into the database for comparative analysis. Of these, 4865 routine data audit (DA) inspections were analyzed: 401 from clinical trials performed in Western Europe, 230 in CEE, 3858 in the USA, and 376 in other countries. The average number of deficiencies per inspection ranged between 0.99 for CEE and 1.97 in Western Europe. No deficiencies were noted during 16.6%, 39.0%, and 21.5% of the inspections in Western Europe, CEE and USA, respectively. The percentages of inspections after which no follow-up action was indicated were 36.9% ...Continue Reading

References

Feb 17, 2000·Annals of Oncology : Official Journal of the European Society for Medical Oncology·M Ben-AmG Burke
Jul 24, 2003·International Journal of Clinical Pharmacology and Therapeutics·P Platonov

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Citations

Jul 22, 2017·Journal of Empirical Research on Human Research Ethics : JERHRE·Gabriela E MinayaNúria Homedes
Jun 23, 2019·Scientific Reports·BanuPriya SridharanTimothy P Spicer
Sep 10, 2016·The Veterinary Record·S P Wensley

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