For the better part of a decade, drug and medical device companies have shipped a growing percentage of their clinical trials for new drugs and medical devices to foreign nations. A new wave of regulation, however, much of it aimed at protecting test subjects and assuring the integrity of data, is presenting new compliance challenges and changes to how those studies are conducted at home and abroad.
With large populations, a low-cost of doing business, and a huge potential marketplace, countries like China and India have attracted an increasing share of clinical trials. “It’s a question of economics. It is simply cheaper to do your trials overseas and that’s driving more and more folks to push their trials,” says Matthew Weinberg, CEO of The Weinberg Group, the nation’s largest independent auditor of clinical trials. Even those traditionally business-friendly environments, however, are taking a fresh look at how trials are conducted. Regulations in the United States and European Union are also becoming more stringent and some countries want more controls on clinical trials done abroad if manufacturers want to sell into their markets.
