Outsourcing Clinical Trials

Episode: 
27

Dear radio listener: Have you heard commercials looking for volunteers for a new drug study? These ads aren’t always successful, so drug companies have found a new and cheaper way to run clinical trials. They outsource them. Their cost per volunteer in U.S. trials is around $20,000. India averages one-tenth of that, at $2,000 per person.

It takes a lot of time and effort to develop a drug before it reaches your medicine cabinet. Each drug must be tested first on animals, then on people. The clinical trials are intended to be rigorous and highly structured to determine if the drug is safe and effective.

Recruiting participants for a clinical trial is one of the most challenging and expensive aspects for U.S. pharmaceutical companies. Most people are unwilling to be exposed to something that may do them more harm than good, or to be poked and prodded by physicians trying to understand how a drug affects the human body.

Some drug companies have solved their recruitment problem by turning to more fertile ground overseas. Many clinical trials take place in developing countries in Eastern Europe, Central America, and Asia. Nearly two-thirds of clinical trials are currently conducted outside the U.S. and this number keeps rising by 15 percent each year.[1] Of all human subjects enrolled in clinical trials, 4 out of 5 live outside the U.S.[2]

This trend is likely to continue. It’s cheaper, faster, and easier. Drug studies offer many individuals their only access to needed medical treatment. Participants are also paid for their services, sometimes more than what an average worker would earn in an entire year. That sounds like a great arrangement.

But there’s a story behind the story. AIDS researcher Dr Charles van Der Horst highlights some of the problems. He says, “There are language issues, there’s corruption in the government . . . It’s just a mess. There’s an enormous amount of unethical research going on.”[3] Outsourced clinical trials attract desperate, impoverished patients who need money and medical care. Regulatory oversight is inconsistent. Informed consent is lacking for patients who didn’t really understand what they’re getting involved in. They may be coerced to remain in the trials, although U.S. patients are told up front they are free to quit. Some participants may think that they are receiving standard treatment or care, or they may be denied care for other conditions if they object to the trial.

As Christians, we should expect just and fair treatment of these patients. For starters, there should be ethical, consistent regulatory oversight of all trials, whether domestic or international, to assure that ease and lower cost do not diminish the reliability of the trial. Patients should be guaranteed the right to opt out. And they should not be denied other medical care. They should be properly informed of the potential negative effects in order to respond with appropriate consent.

Our medicine cabinets should not be stocked with drugs that exploited the poor.



[1] Seth W. Glickman, et al., “Ethical and Scientific Implications of the Globalization of Clinical Research,” New England Journal of Medicine 360 (2009): 816.

[2] Gardiner Harris, “Concern Over Foreign Trials for Drugs Sold in U.S.,” New York Times, June 21, 2010. http://www.nytimes.com/2010/06/22/health/research/22trial.html

[3] Kevin B. O’Reilly, “Outsourcing Clinical Trials: Is It Ethical to Take Drug Studies Abroad?” amednews.com, September 7, 2009. http://www.ama-assn.org/amednews/2009/09/07/prsa0907.htm

 

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