Globalization of Clinical Trials

Researchers from the Duke Clinical Research Institute and the Duke Translational Medicine Institute wrote an interesting article that was just published in the New England Journal of Medicine. If you don't have the time to read the full paper (it's really not that long), you can find a brief summary of their manuscript in this article from the Triangle Business Journal (affectionately known as the TBJ, thank you Jess). I did notice that only two of the authors are mentioned in the TBJ write-up (the only two who are affiliated with UNC, in addition to Duke), and there’s actually no mention of the Duke Institutes, which all the authors are affiliated with. It makes me a little curious about how the TBJ found out about this...possibly a UNC press release?

Nonetheless, this is a complicated issue and I found the authors’ discussion of the historical and current situation well-balanced. By enumerating both the pros and the cons, of globalizing clinical trials, they not only aid in the understanding of the present trend, they also initiate the necessary discourse about the ethics and the response. Moreover, they conclude with a number of proposals, “next steps” as they put it, empowering the academic, medical, and legislative worlds to respond.

**A curiosity: All of the authors on this paper reported conflicts of interest (which they are required to document in order to publish) – which you can only find details about in the Supplementary Appendix online. Turns out they all have involvement (intellectual and monetary) with a wide variety of Pharma and BioTech companies.**