The Advantages and Challenges of 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.

The Challenges of Globalized Clinical Trials

Perhaps the overarching challenge that is associated with conducted globalized clinical trials is need for project managers to complete the trial within a specified timeframe, a need that is complicated by the geographic distances, differences in time, language and culture that may exist among the regions being evaluated. In this regard, Glancszpigel and Racaro (2007) report that, "One of the main challenges project managers face in managing global trials is achieving the 'last patient in' milestone on time. Delays in site activation have a significant impact on all study milestones" (p. 54). Further, launching a globalized clinical trial is complicated by disparities in procedures, contracting processes and resource availability (Glancszpigel & Racaro, 2007).

Moreover, the regulatory environment in which globalized clinical trials are conducted is highly dynamic, and requirements can change during the conduct of the trial necessitating refinements (Glancszpigel & Racaro, 2007). Not surprisingly, globalized clinical trials that involve large numbers of practitioners and participants inevitably also cost far more than localized trials (Rodwin, 2011). Finally, issues such as obtaining informed consent in different countries in different languages (sometime several within a single country), introduces yet more challenges as well as problems with ensuring compliance with experiment regimens (Rodwin, 2011).