According to a report in The New England Journal of Medicine (the Journal), clinical trials are leaving the U.S. and migrating to developing countries at an alarming rate.
· For the 20 largest pharmaceutical companies, one-third of the trials (157 of 509) are being conducted solely outside the United States
· Majority of study sites (13,521 of 24,206) are outside the United States
· Sites outside the United Statesmore than doubled in 10 years
· The proportion of trials conducted in the United States and Western Europe decreased
The Journal sites three major reasons for this dramatic shift:
Cost Savings
A pharmaceutical executive reported that a first-rate academic medical center in India charges approximately $1,500 to $2,000 per case report, less than one-tenth the cost at a second-tier center in the United States.
Shortened Time Lines
In 2000, the cost to develop a new drug averaged $802 million, with time costs accounting for one-half of that amount. The large pool of potential research participants and the lower cost of research in countries, such as China and India, provide opportunities to accelerate recruitment.
Regulatory Restrictions
An important force that is moving clinical trials to developing countries is the increasingly bureaucratic and expensive regulatory environment in many wealthy countries.
Regulations governing the conduct of clinical research have become more and more complex, placing a greater burden on investigators in terms of compliance, documentation, and training.
In the United States, the costs of conducting clinical trials have generally outstripped federal funding for clinical research and strained industry's site-level research budgets.
Although these regulations are well intentioned, they are generally uncoordinated and frequently have not been subjected to empirical studies to determine which elements improve the conduct of trials and which elements add cost without benefiting participants or the research mission.
Before enacting further regulations on industry governments and regulatory bodies, we need to consider the potentially devastating side effects of those regulations. What may sound like a “good” idea, needs to be flushed out with real evidence:
A) Is there an actual versus perceived problem?
B) Are the proposed changes based upon empirical versus anecdotal evidence?
C) What are the full economic consequences of regulations or rules?
D) Is there an actual economic, societal or patient benefit to passing the legislation or nongovernmental rule?
If we continue the trend of greater regulation, this shift in clinical trials to developing countries will only accelerate and further weaken our economy.
The New England Journal of Medicine: Ethical and Scientific implications of Globalization of Clinical Research
The Wall Street Journal: Most Clinical Trials Done Abroad
The Wall Street Journal Blog: How to Lure Clinical Trials Back to the U.S.