The ethics of pharmaceutical companies conducting late-stage human drug trials overseas is the hot topic of the day. An article published today by a few researchers from Duke University in the New England Journal of Medicine has sparked a debate among the big guns: the Wall Street Journal, the New York Times, CNN, Triangle Business Journal, HealthDay, even the FDA is chiming in.
A point of debate includes whether drug research in other countries where there may be genetic variations (such as in East Asia where the physical reaction to nitroglycerin varies) is relevant to American populations. It is questioned whether a trial for fibromyalgia for instance, is even needed in a country where tuberculosis is the norm. Lack of foreign oversight by institutional review boards, adequately discussed informed consents for subjects, and unfair financial inducements to subjects are some of the other points of discussion. The author’s research methods are also under fire.
Right or wrong, the best way to conduct ethical overseas drug trials is to ensure the rights of the trial subjects. This needs to happen through clear and concise communication with patients. Their rights are protected and the integrity of the pharmaceutical industry is preserved only when they are able to fully understand the process they are undertaking.
To ensure clear and concise communications overseas, a top-quality language vendor who specializes in medical and life science translation must be utilized. Not only do we provide translations performed by professional linguists with advanced degrees in medicine, biology, chemistry and pharmacology, aiaTranslations also has a new product, REEL CONSENTTM, an instructional video designed to provide improve enrollment and consent quality in non-English speaking and low literacy populations.
To see the original article by the New England Journal of Medicine, click the link below:
http://content.nejm.org/cgi/content/full/360/8/816
Reaction articles include:
CNN.com
http://www.cnn.com/2009/HEALTH/02/18/outsourced.trials/index.html
HealthDay
http://www.healthday.com/Article.asp?AID=624242
Triangle Business Journal
http://triangle.bizjournals.com/triangle/stories/2009/02/16/daily42.html
Go to www.wsj.com and www.nytimes.com to see responses from the Wall Street Journal and the New York Times.
