From Russia with (3 to 20 times more) Love

“Russia’s Clinical Trials are a Thriving Business”, trumpeted the news release that came to my inbox the other day. Inside was a rather startling – and ever-so-slightly odd – claim:

NPR Marketplace Health Desk Reporter Gregory Warner uncovers the truths about clinical trials in Russia; namely, the ability for biopharmaceutical companies to enroll patients 3 to 20 times faster than in the more established regions of North America and Western Europe.

Of course, as you might expect, the NPR reporter does not “uncover” that – rather, the 3 to 20 times faster “truth” is simply a verbatim statement from the CEO of ClinStar, a CRO specializing in running trials in Russia and Eastern Europe. There is no explanation of the 3-to-20 number, or why there is such a wide confidence interval (if that’s what that is).

The full NPR story goes on to hint that the business of Russian clinical trials may be a bit on the ethically cloudy side by associating it with past practices of lavishing gifts and attention on leading physicians (no direct tie is made – the reporter however not so subtly notes the fact that one person who used to work in Russia as a drug rep now works in clinical trials). I think the implication here is that Russia gets results by any means necessary, and the pharma industry is excitedly queuing up to get its trials done faster.

However, this speed factor is coupled with the extremely modest claim that clinical trial business in Russia is “growing at 15% a years.” While this is certainly not a bad rate of growth, it’s hardly explosive. It’s in fact comparable to the revenue growth of the overall CRO market for the few years preceding the current downturn, estimated at 12.2%, and dwarfed by the estimated 34% annual growth of the industry in India.

From my perspective, the industry seems very hesitant to put too many eggs in Eastern Europe’s basket just yet. We need faster trials, certainly, but we need reliable and clean data even more. Recent troubling research experience with Russia -- most notably the dimebon fiasco, where overwhelming positive data in Russian phase 2 trials have turned out to be completely irreproducible in larger western trials –has left the industry wary about the region. And wink-and-nod publicity about incredible speed gains probably will ultimately hurt wider acceptance of Eastern European trials more than it will help.