Costs and larger trials among the factors driving the globalization of clinical trials
Although significant drug and medical device R&D activity remains within the United States, representing close to 50% of total worldwide expenditures over the last 10-15 years, a clear trend toward globalization has emerged. Many would argue that cost is the primary factor driving this development, however, research suggests that other key factors are contributing as well. Some of these factors include an overall increase in R&D activity, lower enrollment rates in developed countries, and larger trials. It is currently estimated that 50% of all pivotal clinical studies contain data from foreign trials.
We see many drug and medical device companies go overseas to supplement or use as a substitute for U.S. based studies, what surprising is that Western Europe is no longer the only destination. New countries such as China, India, Hungary, Ukraine and various South American countries are emerging as preferred foreign site locations since they offer ample patient populations, faster enrollment and less stringent regulatory environments necessary to initiate and complete effective clinical testing.
In addition to the myriad of legal, cultural and social challenges that exist when conducting global clinical trials, there are many insurance considerations as well. If you are conducting a foreign clinical trial, we encourage you to check out WGA’s latest white paper addressing the important risk management issues that should be identified, understood and addressed.