Concerns Raised Over Outsourcing Of Drug Trials

Reuters reported on Tuesday that a new report issued by the nonprofit group Access to Medicines Index highlights concerns over major drug companies that outsource clinical trials in developing nations to so-called contract research organizations (CROs). According to the report, these companies are not sufficiently open about this outsourcing and, in fact, not a single company was fully transparent about the CROs used. Additionally, only four of the companies mentioned in the report appeared to properly implement internal procedures to ensure that CRO trials were conducted in accord with relevant safety and ethical standards.

The increase of drug trials in developing nations has raised ethical and safety questions in recent years. According to a 2011 PBS News Hour story on these trials, many trials now take place in countries such as India, Thailand and in Eastern Europe. According to the report, one of the primary concerns in conducting trials in these locations is whether the participants ever actually give informed consent, or are people signing up for the trials out of desperation? Another concern highlighted is that it may be quite difficult to actually collect reliable data in these countries.

These are but a few of the ethical problems with these trials. However, there are also clear benefits to conducting these trials in developing nations. Nevertheless, these reports make apparent the need to ensure that any drug trials, especially those conducted in developing nations and poor areas, must meet certain commonly accepted ethical and safety standards. If not, the health and well-being of the trial participants may be jeopardized. Contact our firm to discuss your options if you were harmed by a defective drug.