Drug Testing Goes Offshore

Drug Testing Goes Offshore

1. Do you think it is appropriate for a pharmaceutical firm to conduct most of its clinical trials in less developed countries? Why or why not?

Granted the lack of patient recruitment is the leading cause of clinical trial delay and high costs in the U.S., I don’t think it’s appropriate for companies like GlaxoSmithKline and the like to outsource clinical trials to impoverished countries. Although outsourcing saves pharmaceutical firms money and time to the market, the question to ask is, if the patients recruited understand completely what they are being recruited for and the possible risks involved?

Most importantly, instead of pharmaceutical firms controlling the trial process they are allowing their contracted companies to by subcontracting out to local doctors. Though the firms seem to have a hands off approach over what their contractors are doing, lack of knowledge does not exclude them from any responsibility from negative results. Basically, these pharmaceutical companies are taking advantage of the poor and homeless people in less developed countries because they are not being properly educated on the trial process, provided adequate care or given compensation – all things they must do in the U.S.

2. How can a pharmaceutical company ensure that clinical trials meet the FDA standards noted above?

One way pharmaceutical companies can ensure clinical trials meet FDA standards is to enter overseas markets by establishing turnkey projects instead of contracting out operations. Using this method would take time and money, which would delay bring drugs to market quicker, but it would ensure drugs brought to the market were safe and met FDA requirements. Turnkey project would allow pharmaceutical companies to maintain control from the design and construction of a lab to hiring and training local doctors to operate the way they want.

Is it realistic?

Yes, if the pharmaceutical companies...