Managing advantages and challenges in globalized clinical trials

¶ … Globalized Clinical Trials

As a part of a research team within a research consortium that is preparing to conduct a large-scale trial in multiple locations around the world, it is important to fully understand the advantages and challenges that are involved in managing globalized clinical trials. To this end, this paper reviews the relevant literature concerning these issues, followed by a summary of the research and important findings concerning the advantages and challenges that are associated with globalized clinical trials in the conclusion.

The Advantages of Globalized Clinical Trials

The trends are clear and there has been a steady increase in the use of globalized clinical trials by the biopharmaceutical industry in recent years, especially in several developing regions of the world including Latin American, Asia, and Central Eastern Europe, where medical care has languished despite efforts by national and international authorities to deliver modern healthcare services (Glancszpigel & Racaro, 2007). As discussed further below, although there are a number of challenges involved in conducting globalized clinical trials, there are also a number of advantages that can be realized using this approach, including most especially providing health reform to underdeveloped nations in dire need of improved medical care, but only in best case scenarios. For instance, Metzl and Kirkland (2010) report that, "In the most optimistic circles, one heard talk of the benefits of globalized clinical trials that would provide new medical resources to populations that had previously been unable to obtain them" (p. 47). In addition, globalized clinical trials provide researchers with a much broader base of data that improves the validity of their findings (Rodwin, 2011). As noted above, though, there are some significant challenges involved in conducted globalized clinical trials and these issues are discussed below.

Conclusion

The research showed that there are a number of advantages to conduct globalized clinical trials, including most especially the ability of researchers to gather large amounts of relevant data using established protocols and modern scientific methods as well as providing desperately needed healthcare services to underserved regions of the world. The research also showed, though, that globalized clinical trials cost more, and the process is complicated by a number of challenges, including completing the trials on time, the availability of requisite resources, cross-cultural and contractual differences and a dynamic regulatory environment.