Outsourcing of Clinical Research

[The following text is an example or "case", which can serve as a starting point for reflection and discussion. Some examples may be based on real events, while others are fictional representations.] 

It is not only Western companies that outsource their production of goods and services to other parts of the world. The actors behind clinical medical trials also benefit from the opportunities of the global market. In a report published in February 2009 in The New England Journal of Medicine, researchers from the Duke Clinical Research Institute have shown that trials are being relocated at an unprecedented rate. This presents both ethical and scientific challenges. The researchers have examined clinical trials conducted by the 20 largest medical companies in the United States. An analysis of 300 reports over a ten-year period from 1995 to 2005 showed a doubling of trial sites outside the U.S. Testing now primarily takes place in former Eastern Europe, Russia, Africa, and Asia.

The establishment of new branches of the U.S. Food and Drug Administration (FDA), which oversees ethical human trials, has also increased by 15 percent outside the U.S. At the same time, the number of FDA offices in the U.S. has decreased by 5 percent, according to the researchers. They argue that the increasing globalization of medical trials is a relatively new phenomenon that the international community should pay greater attention to in the future.

There are many reasons why trials are being outsourced. Not surprisingly, conducting trials in other parts of the world is significantly cheaper. The cost per participant in India is only one-tenth of the expenses in the U.S., says Seth Glickmann, the leader of the research group, in a press release. The wages of local healthcare personnel are far lower than in the West. Furthermore, there is greater access to test subjects in overpopulated developing countries. Another important factor is the time-consuming regulatory system of institutions and oversight bodies in wealthy Western countries. In developing countries, regulatory barriers are much lower, and trials can be conducted at a much faster pace.

Outsourcing also has some positive aspects. It may be the only opportunity for healthcare personnel in developing countries to engage in research.

Discuss this situation in light of the principle of vulnerability. Try also to identify which mechanisms should be put in place to protect groups of people who require special safeguards.

This case is taken from I. Haraldsen, "Testing Medicines in Poorer Countries" ("Tester medisiner i fattigere land"), published on forskning.no in February 2009 (In Norwegian).

Note: This is a translation of the Norwegian original text by Johanne Svanes Oskarsen.