May 15, 2004 | What may not be obvious about global trials is that minor details, gone awry, can erase the advantages. Joseph Anderson, principal associate at Waife & Associates, ran trials in Frankfurt, Germany, before relocating to the United States to help Waife advise clients about technology used in clinical trials.
Fluent in German, Anderson says EDC can help gather data quickly anywhere in the world. But he also points out that a frugal customer is likely to balk if EDC raises the cost. "If the reason I'm going is that I want to be cheaper, why would I want to add EDC? For some sponsors, that's an extra barrier," Anderson says.
Mundane details matter. It's one thing to send two laptops to Russia. It's another to send 100. "A certain number of them won't get there on time; a certain number won't work," Anderson says. "Technology enables these trials to happen. That's the great thing. What people are struggling with is the logistics of supporting the technology that far away."
Telephone lines, Anderson says, are of good quality — just not in great supply. "There are plenty of stories of medical institutions in Russia where you have to go through an external operator to use the phone," he says. That may complicate dialing into a server in Pennsylvania.
Sponsors new to the rest of the world and working with vendors without extensive international experience should be careful. There are too many glitches to list. "None of them are insurmountable," Anderson says. "But if you're not there on top of them, you lose the advantage of EDC, which is to get things in faster and cleaner."
One of the ironies of the present era, Anderson points out, is that paper processes in the industry are so dismally slow that getting paper from Latvia does not add significantly to the workflow. Even under the best of circumstances, Waife & Associates estimates it may take a typical sponsor eight weeks to get paper-based clinical data into a database. If a courier service adds another week, who cares?
Perhaps the best news, Anderson says, is that the clinical staff members in Eastern Europe are more enthusiastic and less reluctant in their disposition. New tools and EDC interfaces don't perplex them. "The monitors and people like that tend to really like using these tools. You're not dragging them away from a paper process like you are in the States. You usually get an enthusiastic, forward-thinking type of response."
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