OUTSOURCING CLINICAL DRUG TRIALS
September 28, 2005
Pharmaceutical companies are increasingly conducting clinical trials overseas in order to cut costs and reduce the time it takes to get drugs to the market, says Abraham Lustgarten of Fortune Magazine. However, lack of ethical standards and oversight concern many.
Currently, about 40 percent of clinical trials are conducted in poorer or developing countries. This arrangement offers several advantages:
- Conducting trials in the United States costs about $30,000 per patient, compared to only $3,000 per patient in Romania.
- Patient recruitment is quicker; in Russia, patients can be recruited 10 times faster than in the United States.
- Thus oversees trials can be completed in three to six months less time, meaning a drug gets to the market faster.
However, potential conflicts arise with regard to ethics and standards. Russian doctors, for example, can earn 10 times their salary by recruiting their patients into studies. Additionally, patients have been known to bribe doctors into allowing them to participate in trials, with the hope of free medicine.
The Food and Drug Administration (FDA) has established internationally accepted guidelines, and requires international sites to be open to inspection, but the process is lacking:
- In 2004, only 100 sites around the world were inspected by the FDA; in Russia alone last year, there were some 3,000 sites where clinical trials took place.
- Of the 100 site inspected, 30 percent failed to follow protocol, and one in 12 cites was cited for failure to disclose adverse patient reactions.
Regardless of whether ethical standards improve globally, trails will continue to shift to poorer countries due to lower costs and faster recruitment, says Fortune.
Source: Abraham Lustgarten, "Drug Testing Goes Offshore," Fortune, August 8, 2005.
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