Western Europe seemed to take the biggest hit last year from sharp increases in the number of clinical investigators in countries such as Poland, Ukraine and India signing up for clinical trials regulated by the US Food and Drug Administration (FDA), suggests an analysis by Parexel International.

While limited to trials conducted under a US Investigational New Drug (IND) application and for which the necessary Form FDA-1572 (Statement of Investigator) or other paperwork was completed during 2007, the analysis of data from the FDA’s Bioresearch Monitoring Information System does give a flavour of how much newly initiated clinical trials are shifting from well-established territories such as the US and Western Europe to emerging markets in Asia, Eastern Europe or Latin America.

“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”, comments Parexel in its recently published Bio/Pharmaceutical R&D Statistical Sourcebook 2008/2009.

In fact, the most dramatic leap in FDA-regulated trials was seen in Japan, where the number of clinical investigators signing Form 1572s shot up from 24 to 2006 to 154 in 2007. That still left Japan ranking 20th among the countries with investigators registering for FDA-licensed trials last year, with less than a 1% share of all investigators completing 1572s. The Japanese authorities have been making concerted efforts in recent years to sweeten what has traditionally been a challenging environment for clinical trials.

More in line with observed trends was a 47% increase in clinical investigators completing 1572s in Poland (405 in total), moving the country up to 7th slot in the rankings from 12th in 2006. The number of investigators signing up for FDA-regulated trials in Ukraine surged by 81% to 255, catapulting that country from 23rd to 13th place with a 1.1% share of all completed Form 1572s.

The year-on-year growth in Russia was a relatively modest 8.8% to 482 investigators, although it was enough to secure 5th position with a 2.1% share, up from 7th in 2006. And India rose from 10th to eighth place, with 395 investigators signing up for FDA-regulated research – 29% more than in the previous year.

US down

In the face of these aggressive growth trends, the number of US-based investigators completing 1572s in 2007 dipped by 4.8% to 12,975, while the dominant US share of FDA sign-ups shrank to 57.6% from just over 59% in 2006. The US was still well ahead of the next most popular source of investigators registering for US-licensed trials – Germany, with 976 investigators and 4.3% of the total (ahead of Canada).

But other Western European countries were feeling the pinch. France, for example, witnessed a 37% decline in the number of investigators completing 1572s, bringing its share of the total down from 2.6% to 1.8% and its ranking down from third to sixth. The UK slid from sixth to ninth slot, with its share dwindling from 2% to 1.6% as the number of investigators fell by 25% to 349. Italy was down by 21% against 2006, to 309 investigators.

One oft-cited growth market for clinical trials that did not see any dramatic increase in completed 1572s last year was China (including Hong Kong). The 131 clinical investigators signing up for FDA-regulated trials were just 5.7% ahead of 2006, although China’s ranking improved from 31st to 25th.

None of the individual countries in Latin America, another emerging region for clinical research, saw significant growth in the number of investigators completing 1572s during 2007, Parexel notes. However, Latin America did take four of the top 23 spots in the rankings – Argentina in 10th place with 1.5% of the investigator pool (1.6% in 2006), Mexico at number 14 with 15% more investigators than in 2006, Brazil dropping from 14th to 16th and Chile up from 25th to 23rd.

In total, 22,529 clinical investigators from 96 countries around the world signed new Form FDA-1572s during 2007. “After spiking 24% in 2000, the number of clinical investigators signing up for FDA-regulated clinical trials has remained largely flat in recent years,” Parexel comments.

In fact, last year’s tally was 2.5% below 2006 but, as Parexel observes, “the number [of investigators] has remained in a reasonably tight range near the record high over the last four years” – not surprising, it adds, “given the record levels of FDA-regulated studies that industry has initiated in recent years”.