Clinical research can be accomplished more quickly in countries with large populations of appropriate subjects, and at lower costs in those countries especially when they have lower costs of personnel and facilities. This article focuses on the risks involved in the change of clinical trials of new pharmaceuticals from Western Europe and the United States to other, less developed regions of the world. It discusses both the risks to the subjects of that research, and to the quality and generalizability of the results.
Clinicaltrials.org, a US website on which all government-funded and many company trials are listed, shows nearly 50,000 under way, of which 10 per cent involve countries outside North America, western Europe and Japan.Comment: I find the volume of clinical trials surprising, but otherwise this article reflects concerns that have been growing over time.
The proportion of principal investigators – the lead researchers on a trial – registered with the US Food & Drug Administration (FDA) but based outside the US and western Europe rose from 5 per cent in 1997 to 29 per cent last year. The fastest growth in the past five years has come from India, China, Russia and Argentina.
However, I would note that the drugs that are proven efficacious in Europe and the United States are then used all over the world. There is a risk involved for the subjects in clinical trials, and ethically that risk should be shared among all populations that are likely to benefit from the results of the trials. The fact that five percent of the world's population living in the United States are more than than five percent of the subjects of clinical trials might be of concern.
Perhaps an alternative standard for comparison might be the pharmaceutical volume used in different countries; perhaps it would be ethically preferable to draw subjects from countries in proportion to the amounts of drugs that they consume? Expenditures on drugs would not be as good a basis for comparison, unless they could be adjusted for the differences in pharmaceutical prices among countries. JAD