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It doesn't just take a village to raise a child, it takes one to successfully run multiregional trials. So implies the mega track plenary session "Multiregional Clinical Trials: It Takes a Global Village of Expertise." Among the handful of expert presenters speaking at the Monday morning 10:30 session is Doug Peddicord, PhD, Executive Director of the Association of Clinical Research Organizations (ACRO).
During the mega session, Peddicord plans to focus on "the scope of the issue," that is, the increasing number of trials being performed outside the United States and Europe in countries like China, Russia, India, and Korea. He cited clinicaltrials.gov numbers that break down the global trials scene as 50% U.S., 25% Europe, and 25% rest of the world. The latter, emerging regions are where ACRO members are seeing more trial activity and the type of growth Peddicord described as "very significant."
Although it might seem old hat to ask why go global, since it's been happening for years, there's one assumption that might still need clearing up. "I think people may often assume that cost is kind of a driving factor," said Peddicord, "but I actually think that's much less an issue, partly because I think the logistics of multiregional trials are complicated and expensive." Of course, they're manageable with proper handling—Peddicord speaks highly of global SOPs—and can initially provide savings, but globalization is financially feasible only later on.
That's after FDA approval when a product needs a market and a sponsor has already established itself comfortably in an emerging one. That physical presence helps companies down the road, explains Peddicord, when they want to sell their product in that country. "Many of those emerging markets are small now," he said, "but have enormous populations which may be consumers."
These populations may also yield future trial participants or highly skilled investigators passionate about clinical research. And access to both groups, says Peddicord, is also behind the global trend. Faced with low U.S. recruitment numbers and/or investigator inactivity, Peddicord says trials go global for the same reasons other activities do: "If you limit yourself only to the United States you have roughly 350 million people. If you do the United States and Europe, you get 700 million people; and if you do the entire world, you have 7 billion people."
From a business perspective, that should translate into shorter gestational periods—Phase I to market—for successful investigational drugs and tops the list of why sponsors look beyond U.S and European borders. Instead of engaging only half a dozen sites, a wider net cast ideally means sponsors can have 30 sites up and running at once. "Clearly the faster you can get your new drug or biologic or medical device on the market, the better," said Peddicord.
But it's not all business, either for Peddicord, who will also address clinical, ethical, and regulatory considerations for global trials, or for globalization. First and foremost, before visions of new market successes, always comes ethics. "Any company that is looking to conduct trials, especially in emerging markets" he says, "really needs to be able to have in place processes and standards to ensure that ethical and regulatory standards get met."
It should be a uniform approach to performing studies around the world that Peddicord describes as being carried out globally but with local determination, the kind that precedes expectations for meeting FDA’s own strict requirements.