1. Identify three factors that are driving pharmaceutical companies to host clinical drug trials overseas.
2. What regulations are in place to oversee the professional and ethical management of these trials?
3. If patients lack the language skills or education to understand the significance of informed consent or the use of a placebo, is it ethical to allow them to participate in the drug trial? Why or why not?
4. What proposals would you offer to make the offshoring of clinical drug trials a more ethical process for all the stakeholders involved?
The process of offshoring (outsourcing an organizational function overseas) is being applied to clinical drug trials with the same speed and enthusiasm as major U.S. corporations transplanting their customer service call centers to countries such as Ireland, India, and increasingly further eastern locations. In a report released in June 2010 by Daniel R. Levinson, the inspector general of the Department of Health and Human Services, 80 percent of the drugs approved for sale in 2008 had trials in foreign countries, and 78 percent of all subjects who participated in clinical trials were enrolled at foreign sites. Ten medicines approved in 2008 received no domestic testing at all.