MOST CLINICAL TRIALS DONE ABROAD
February 20, 2009
U.S. drug companies are increasingly conducting late-stage clinical trials abroad, reducing their costs, but raising ethical concerns.
A study published in the New England Journal of Medicine found:
- Out of 24,206 testing sites, 13,521 sites being used by U.S. drug companies in November 2007 were international.
- The number of countries conducting testing has doubled over the past 10 years.
These findings add to concerns about the ethical treatment of participants and the integrity of the research data produced in developing countries. Experts also say patients in developing countries may be taken advantage of because they are poorer and less familiar with the research process:
- In November, Indian drug regulators halted a trial of a Wyeth vaccine after an infant died, in order to determine whether babies enrolled in the study were being properly screened.
- In a 2007 Polish study of a bird-flu vaccine, two elderly patients died who should have been excluded based on age.
Helping to make overseas trials cheaper and faster, patients in developing countries are often more willing to enroll in studies because of lack of alternative treatment options, and often they aren't taking any other medicines. Thus, it is easier to show that experimental treatments are better than placebos.
The authors of the study suggest that bureaucracy and regulatory hurdles in the United States are partly responsible for making going abroad so enticing. The requirements stretch out the amount of time it takes to complete a study and can add to costs as well. "Many of the policies in regards to the regulatory framework are well intentioned," says first author Seth Glickman of the University of North Carolina - Chapel Hill. "They have the unintended effect of being very onerous from the administrative standpoint."
Sources: Shirley S. Wang, "Most Clinical Trials Done Abroad," Wall Street Journal, February 19, 2009, and Seth Glickman et al., "Ethical and Scientific Implications of the Globalization of Clinical Research," New England Journal of Medicine, Vol. 360, No. 8, February 19, 2009.
For WSJ text:
For study abstract:
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