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Recent white paper from ACRO emphasizes the need for global trials.
Like many industries, clinical research is no stranger to the allure of the global world. Its advantages are plenty, and for most, read like a memorized shopping list: lower costs, shorter timelines, more patients. But unlike other industries, going global with clinical trials raises red flags in many circles.
Established vs Emerging Markets
"Pretty much everything out there is negative," says Todd Clark, referring to press covering the global expansion of trials. To get beyond this, what it calls anecdotal reporting, the Association of Clinical Research Organization (ACRO) commissioned Clark to do some research. The result is the white paper, The Case for Globalization: Ethical and Business Considerations in Clinical Research.
When asked if any of the findings in the midsummer report surprised him, ACRO's Executive Director Doug Peddicord said there were two: the small size of the marketplace emerging countries currently constitute and how some act stricter than U.S. and EU bodies.
Clark likened this strictness to paternal protection. "In Latin America, especially in Brazil," he said, "it is virtually impossible to do a placebo controlled trial...they think it's sort of excessive experimentation to some degree. And in India, you cannot do as a foreign sponsor a Phase I first-in-human trial."
India also provides an example of what the white paper says may prove an additional layer of oversight in less developed countries: close relations. It cites one study in which 92% of Indian patients said they consulted with family or friends before enrolling in a trial, compared with just 62% of the Americans.
Positive findings like this are heavily sprinkled throughout the 39-page pro-global report to support its thesis that "emerging countries play a vital role in the advancement of medical science." With them, it finds, years can be shaved off Phase III cancer trials via shorter enrollment times. Which means drugs get to patients, get to market faster—"In truth," notes the report, "the largest benefit of globalized trials."
None of that matters, of course, if the quality isn't there. Which is a common criticism. How can a country with little experience ensure good clinical quality? The answer: with some help, which has come from industry and CROs. It seems the consensus view is that their growing global presence over the past 10 to 15 years has created a wider knowledge base.
Both groups are at the forefront of education, says FDA Senior Advisor for Clinical Science David Lepay, MD, PhD. He told Applied Clinical Trials that "It is rare for FDA to approach a country about capacity building without them talking about industry training programs taking place in their country."
Clark credits sponsors for central Europe's rise to nearly being on par with western Europe. Their trials and financial investments in the region are behind its improvement, he says, and better global health care.
Exposing developing countries to clinical research exposes their medical professionals to new equipment, new approaches, new patients. Clark describes it as a "technology transfer and knowledge transfer that improves the level of health services in these countries."
Take Poland for example. According to Clark, 30% of cancer care in its hospitals come from clinical trials. What good would it do, he asks hypothetically, to take away this care because Poland is still an emerging country? That might make sense to globalization skeptics, but it doesn't to Clark. "It's really a case of letting the perfect be the enemy of the good," he says.—Kerri Nelen