U.S.? EU? ROW?
Regulatory and infrastructure differences between the West and the rest of the world may be off-putting, and language and cultural barriers can seem a bit daunting as well. But there are many reasons sponsors might consider conducting all or part of a trial on other shores.
About 80% of trials are behind schedule. This, said Lara, is due principally to patient recruitment, which, in turn, is driven by appropriate site selection.
There are certainly plenty of cancer patients in North America, yet fewer than five percent will ever access a clinical trial. Whatever the reason for this—whether willingness, access, other therapy, geography, or lack of knowledge—“you’re actually ending up in a very narrow funnel of trying to find those patients,” pointed out Nicholas Kenny, Ph.D., evp, oncology, INC Research.
INC will “pressure test” a drug and study design to determine if it will be acceptable to the physicians and the patients that the sponsor is trying to access, and then look into where to best conduct the trial.
For example, because the North American landscape for lung cancer trials is very competitive, with a lot of very good drugs in development for the same indication, “trying to place a new lung cancer study in North America can be quite difficult,” explained Kenny.
“Whereas if you look at some of the emerging regions, or even Eastern Europe, there are still a large number of patients there that might be naïve to clinical trials, or have not been accessed to the same extent. We would look very strongly at alternative geographies.”
There can be substantial cost savings overseas as well. Investigator and site fees in Asia are about half of those in the U.S., pointed out Gargano, while the costs of providing trial-related medications, investigations, and hospitalizations can drop to as low as 30%.
Similarly, labor costs in general are substantially less, and the fact that the region’s more than four billion people are concentrated around major urban areas makes for lower travel expenses for monitoring the sites as well.
Asia-Pacific hosts many specialty care centers with state-of-the-art facilities, and most of the specialists received post-graduate training in the U.S. or U.K. Nonetheless, she cautioned that to insure that the quality of the data collected is up to international standards, it’s still important to assure that staff training and support systems are in place, or that provisions have been made to invest in such infrastructure.
In emerging regions, constraints tend to be centered around “having enough facility with the institutions—whether it’s the community oncology setting or a large academic center—as well as enough physicians and support staff that have been trained in the execution of the clinical trial,” concurred Kenny.