India may rank among the top 10 countries conducting FDA-regulated clinical trials, but there hasn’t been a major influx of trial work. According to Parexel Inernational, the contract research organization, only 306, or 1.3 percent of investigators are based in India.

“There has been so much noise about China and India, but if you look at them in relative terms they are promising but still have some way to go” as major sites for clinical trials, says Gadi Saarony, Paraxel’s corporate vp and general manager.

Parexel analyzed FDA forms investigators must complete before participating in a specific trial and found that, in 2006, 23,089 clinical investigators from 92 countries signed the forms. Most were based in the US: 13,629, or 59 percent of all investigators.

Western European countries have traditionally served as secondary trial sites and they had the bulk of investigators after the United States and Canada. However, Russia ranked No. 7, with nearly as many investigators as the United Kingdom.

Drugmakers have been shifting more clinical research abroad in recent years as foreign countries offer a large supply of patients and lower research costs. And they have cited China, India and Latin America as targets for additional research.

But China didn’t rank among the top 13 countries; it had only 81 clinical investigators signing FDA forms, nor did Japan, which had just 24 investigators. Saarony says challenges remain to setting up in China and India. The labor supply needs training and the regulatory infrastructure is underdeveloped.

“It’s not all that difficult to build a building, but to have a quality trial [you need to have] the right people, regulation and oversight,” he says. “In the rush to get to the next gold mine that’s sometimes overlooked.”

Source: PharmAsiaNews/FDC Alerts