FDA studies outside US minimal, survey reveals

After jumping by 24 per cent in 2000, the number of clinical investigators signing up for FDA-regulated clinical trials has remained largely flat in recent years. During the same time period, the clinical trials industry has been witnessing a definite trend toward the globalisation of clinical research, with a resultant leak in the proportion of trials being run in the US and other Western countries. Despite this, US-based clinical investigators continue to represent the majority of investigators used in FDA-regulated trials, with 13,629 in 2006, representing 59 per cent of the global total. This figure dwarfs the number of investigators from the next most popular country for conducting FDA-approved studies, Canada, with only 893 investigators (3.9 per cent of the total). The Western European countries of France, Germany, Spain and the UK are the next biggest contributors with a combined total of 9.6 per cent (2221 investigators). Meanwhile, although it is not happening as rapidly as some may have anticipated, the number of international investigators applying to undertake FDA-approved trials in offshore locations is still growing nonetheless. The survey suggests that Eastern European countries (EEC) in particular are fast becoming significant players in conducting such trials. No less than 443 Russian clinical investigators applied to participate in FDA-regulated research in 2006, only slightly less than the number of UK-based investigators, 50 more than in Italy, and the seventh most of any country. Significant numbers of clinical investigators in other emerging EEC countries also moved to participate in FDA-regulated studies during 2006: 276 investigators in Poland, 176 in Hungary, 155 in Romania, and 141 in the Ukraine. In addition, South American countries were also well represented, including Argentina (358 investigators), Brazil (225), and Chile (133). However, despite all the hype surrounding the Asia-Pacific area, countries in the region are largely still trailing behind the other two major emerging regions. Only India entered the top 10 countries in which 2006-initiated FDA-regulated studies were being conducted, based upon filings by 306 investigators (1.3 per cent of the world's total). Australia made it into position 11 with 287 investigator requests (1.2 per cent). Only 81 clinical investigators based in China applied to conduct FDA-approved research; while despite Japan being the next biggest drug market after the US, the country had just 24 Japan-based investigators looking to run FDA studies during the year. This is despite a number of Japanese government initiatives launched over the last few years aimed at boosting clinical research in the country in order to eradicate its terrible "drug-lag." The analysis - contained in Parexel's newly-released Bio/Pharmaceutical R&D Statistical Sourcebook 2007/2008 - was conducted by the firm using the FDA's bioresearch monitoring information system (BMIS) to determine the home countries of clinical investigators who completed, during 2006, the necessary regulatory forms to participate in new FDA-regulated clinical studies. It is worth noting, however, that each clinical investigator is counted only once in this analysis, despite the fact that some of the clinical investigators in the sample may be conducting multiple clinical studies for different drug products, particularly in countries in emerging markets where the number of available investigators is usually very limited. Commenting on the findings, Mark Mathieu, director of Publications for Barnett International, the Medical Communications unit of Parexel, told Outsourcing-Pharma.com that the data presents "a nice snapshot of where the industry is right now, despite all the hype." ​ "We are not saying that countries in emerging locations such as India aren't meeting expectations. It is still early on in the game and if some of these emerging countries continue to grow as they are, they will look to overtake a few more established countries." ​ It is also important to note that this study examines only FDA-regulated clinical studies, said Parexel. "Obviously, there is considerable non-FDA-regulated research being conducted worldwide, although FDA-regulated trials certainly provide a large, important, and insightful sample of worldwide studies."​