The much-discussed exodus of clinical trials from well-established territories such as the US to emerging markets like India and China is happening, but not as quickly as might have been expected, suggest new data from US-based contract research organisation (CRO) Parexel.

The Parexel data, taken from the CRO’s Bio/Pharmaceutical R&D Statistical Sourcebook 2007/2008, are not comprehensive. They deal only with clinical studies specifically regulated by the US Food and Drug Administration (FDA), while the figures on the geographical distribution of FDA-notified trials relate to a single year. Given the size and centrality of the US pharmaceutical market, though, the data provide an important sample of the global trend.

Parexel used the FDA’s Bioresearch Monitoring Information System to look at the number of clinical investigators who completed the necessary Form FDA-1572 to participate in trials regulated by the US agency in 2006, as well as the location of investigators signing the form. The analysis revealed that a total of 23,089 investigators from 92 different countries completed the form in 2006, compared with 22,921 in 2005. The annual number of clinical investigators has remained fairly stable in recent years, following an exceptional 24% increase from 17,948 to 22,218 between 1999 and 2000.

The majority of clinical investigators involved in FDA-regulated trials – 59% in 2006, according to the Parexel data – are still based in the US, while investigators located in North America (the US, Canada and Mexico) make up 64% of the total. As the table below shows, there is a perceptible shift of FDA-regulated studies to emerging markets but “this exodus has yet to manifest itself on a large scale,” Parexel comments.

Number of Investigators Completing Form 1572s to Participate in

FDA-Regulated Clinical Studies in 2006: Top 13 Countries

Country / Number of Investigators / % of Total

United States: 13,629, 59.0

Canada: 893, 3.9

France: 600, 2.6

Germany: 583, 2.5

Spain: 576, 2.5

United Kingdom: 462, 2.0

Russia: 443, 1.9

Italy: 389, 1.7

Argentina: 358, 1.6

India: 306, 1.3

Australia: 287, 1.2

Poland: 276, 1.2

South Africa: 232, 1.0

Although India joined the top 10 locations for FDA-regulated clinical trials initiated in 2006, it still lagged significantly behind Argentina, where 358 investigators completed a Form 1572 during the year. Only 81 clinical investigators based in China signed the form in 2006 while Japan – where the government has been trying to revive a declining market for clinical studies – was the site for just 24 FDA-notified trials, Parexel points out.

The data did show that Central and Eastern European countries – often cited as the first wave of emerging markets to attract clinical trial business from more established territories – have become significant players on the FDA-regulated circuit. Russia accounted for 443 Form FDA-1572s in 2006, only slightly fewer than the UK. The form was also completed by 276 clinical investigators in Poland, 176 in Hungary, 155 in Romania and 141 in the Ukraine.

South America was well represented too. Argentina figured among the top 13 countries with 358 investigators signing up for FDA-regulated trials, while Brazil and Chile notched up 225 and 133 apiece.

Variety of obstacles

According to Gadi Saarony, vice-president and general manager of Parexel Consulting, the slower-than-expected emergence of developing markets for FDA-regulated trials reflects a variety of obstacles encountered by companies that have rushed to capitalise on the promise of cost savings and large patient populations.

Often the infrastructure for trials in new markets has not been as ready as these companies had hoped, while suitably qualified investigators can be thin on the ground, Saarony said. Where clinical studies are not part of the local culture, recruitment may be difficult; patient access to clinical trial hubs can also be a problem. While the trend towards siting trials in emerging markets is “absolutely there,” the rate of uptake has not kept pace with expectations, he commented.

Nor is Saarony convinced that an inevitable increase in trials conducted outside the core markets will mean fewer studies in the US, the UK or other traditional locations. In many of the emerging territories, he observed, drug consumption is not at the same level as in the tried and tested markets – although this will change, as will the openness to trials in less developed countries.

While the first priority in conducting clinical trials is recruiting the right patients, followed by having properly qualified and trained investigators (still more easily available in the established markets), costs will inevitable enter the equation from a long-term perspective, Saarony believes. But low-cost centres for clinical trials do not have to mean India or China.

Ethnic offering

There are already markets closer to home in Central and Eastern Europe that offer these advantages and have reached maturity in terms of infrastructure and the skills base, he pointed out. Moreover, the ethnic diversity cited by some companies as a reason to take clinical studies further afield is increasingly available in the mainstream markets. For example, the west coast of the US can provide a rich seam of Japanese patients, Saarony said.

It has been suggested, noted Mark Mathieu, director of publications for Parexel company Barnett International, that the country’s status as the world’s largest pharmaceutical market, not to mention the regulatory and marketing advantages of conducting at least a sizeable proportion of clinical trials in the US, have made it somewhat immune to the diversion trend.

Nonetheless, both Parexel executives expect to see a continuing and accelerating shift in the balance of US- to non-US-based clinical investigators. The trend has already been marked over the last decade. Mathieu pointed to an earlier study by the Tufts Center for the Study of Drug Development, which found that some 85% of Form FDA-1572s derived from the US in 1997. By 2005, however, that proportion had already dropped to around 65%.