India And China Not Yet Major Sites For FDA-Regulated Trials, Parexel Finds
While India now ranks among the top 10 countries conducting FDA-regulated clinical trials, it has yet to see a major influx of trial work.
The contract research organization Parexel International compiled data on the location of investigators sponsoring FDA-regulated studies and found that 306, or 1.3 percent of investigators, are based in India. The data are included in Parexel's Bio/Pharmaceutical R&D Statistical Sourcebook 2007/2008.
"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, Gadi Saarony, corporate vice president and general manager of Parexel Consulting, said in an interview.
Parexel analyzed the FDA forms investigators must complete before they can participate in a specific trial. The group found that in 2006, 23,089 clinical investigators from 92 countries signed the forms. Most of them, of course, were based in the United States: 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 (see chart: "1FDA's Top 13: Trial Distribution By Investigator Location"). Russia ranked No. 7, with nearly as many investigators as the United Kingdom.
Mark Mathieu, Parexel's director of publications, said it was surprising to see that countries such as Russia had already virtually matched the numbers of investigators coming from countries such as the U.K., Germany and France. Saarony added that Russia's lower trial costs and a patient population that's similar to North America and Europe make Russia an appealing trial site.
China did not rank among the top 13 countries as it had only 81 clinical investigators signing FDA forms, nor did Japan, which had just 24 investigators.
Pharmaceutical companies 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 (2"The Pink Sheet" April 30, 2007, p. 31).
Saarony said he often tells pharmaceutical clients that while he doesn't discount the market potential of India and China there are challenges and costs to setting up there and they might want to do so incrementally. Since the labor supply is in need of training and the regulatory infrastructure is underdeveloped, he said companies have to invest in training and in sending people to conduct inspections and oversee the research.
"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 said. "In the rush to get to the next gold mine that's sometimes overlooked."
- Brenda Sandburg
This article is reprinted from "The Pink Sheet" – June 4, 2007
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