Clinical trials overseen by US FDA

Abstract

The Office of Inspector General, US Department of Health and Human Services, released a report in June 2010 entitled Challenges to FDA’s Ability to Monitor and Inspect Foreign Clinical Trials. Based on FDA 2008 drug approvals it was reported that 80% of approved marketing applications for drugs and biologics contained data from foreign clinical trials. Over half of clinical trial subjects and sites were located outside the United States. We analysed the US trial registry in order to identify all clinical trials that were overseen by the US FDA. In addition, the US FDA investigator database was analysed, i.e. the database including all clinical investigators that have been or are presently involved in one or several clinical trials overseen by the US FDA. The Inspector General Report notes that 45.4% of all sites were located to the US, while our analysis gives a figure of 44.4% for industry-sponsored clinical trials listed. The Inspector General Report estimates the European site contribution to be 32.7%, while the US trial registry comes up with a lower percentage of 24.6%. The most significant difference between the two sets of data is the number of sites for East Europe - 6.4% for the Report and 11.0% for the registry data. The figure for Asia goes in the same direction, i.e. 3.4% versus 7.6%. The US FDA investigator database shows a few clear trends. Firstly, the number of US FDA overseen study sites is steadily increasing over time and have reached a plateau from year 2000 onwards of around 37,000 annually. Secondly and not unexpectedly, there is also an increasing proportion of sites located outside the US, where the percentage was less than 10% two decades ago, compared to over 30% presently. In 2004 to 2008, 12.7% of the US sites embarked on its first US FDA overseen trial, and 66.2% of the sites were involved in five or more such trials. Those figures are very different than other regions, with the exception of Canada. For instance, in Europe, as many as 43.8% of the sites were novice to US overseen trials and only 17.6% were experienced sites with participation in at least five such trials, i.e. figures that are quite similar to RoW About 50% of industry-sponsored trials registered in the US trial registry and conducted in Europe were not overseen by the US FDA. Both the US and Europe have recently raised various concerns about the ethics, science, quality and standard medical practice of trials conducted in emerging regions. In spite of the concerns raised, the industry has decided to go global due to the lack of investigators and study participants in North America and Europe. This trend will most certainly continue.