Globalization of clinical research mainly refers to a modern practice of undertaking clinical research in different parts of the world, regardless of the economic outlook of such countries, whether developed or developing. A literature search conducted on the globalization of clinical research yielded three main sources, each of which shares some ideas and conclusions about this new practice. In this review, the purpose of the articles as well as an evaluation of the conclusions drawn by the authors is given. Personal perspective on the challenges and benefits of globalization of clinical research is also provided, with a proposal on ways to overcome the situation.
The first article reviewed was by Laine et al. (2009), who shed light on the overall meaning of globalization of clinical research, as well as focusing on the benefits of the practice. The practice was simply explained to mean the process of conducting clinical research across the globe. For developing countries, it was said that they benefit from capacity sharing, development and investment through the practice. The second article by Lang, Cheah and White (2011) also dwelled on the future impact of globalization of clinical research on the safety of patients. On the issue of patient safety, it was argued that the future prospects are bright because the practice presents opportunities to conduct clinical research directly in settings faced with specific health issues. Lastly, the overarching theme of the study by Glickman et al. (2009) was on the motivation for globalization of clinical research, as well as possible challenges that ought to be looked for an addressed. The motivation for the practice was said to be the need to take clinical research to areas where actual problems exist. This was however said to have the challenge of ensuring and enforcing accepted standards of practice.
In evaluating the conclusions drawn by the three researchers above, it would be said that each of them is well focused in the areas in which they directed their study. For example the argument by Laine et al. (2009) that globalization of clinical research gives developing countries an opportunity for enjoying increased capacity and investment cannot be denied. This is particularly the case because such clinical research that take place in developing countries are mostly financed and sponsored by entities in developed countries. Consequently, the opportunities to have such research trials in those developing countries would not have existed without globalization of the concept. Lang, Cheah and White (2011) also raised the point of guaranteed future safety for patients and this will be strongly agreed with. That is, is has often been the case in times past that even when there is an epidemic in specific parts of the world, clinical trials aimed at solving the health problems are conducted outside the affected areas. This situation sometimes compromise the quality of outcomes since testing on subjects is not done with those directly affected. This point is also reflected in the last author’s conclusion about the motivation for taking clinical research global. That is, health victims become the first to benefit from the outcome of the clinical researches (Glickman et al., 2009).
On the back of the points discussed above, it is still possible to shed some more insight about the challenges and benefits of globalization of clinical research. With this, the main challenge that arises has to do with ethical and standardization difference and how they respond to the studies. Even though there are universally and internationally accepted standards and ethics in clinical research, it is also a known fact that the commitment to enforcing these ethics and standards in different countries vary. In some countries, regulators who ensure and enforce ethics and standards are poorly funded and so do not have the right logistics to go about their work. When situations like this are not checked with the globalization of clinical research, it could have negative impact on the safety of patients because quality of medicines may not be fully authenticated. In order to overcome this challenge, it is recommended that global interests be made to override national interests in the globalization of clinical trials. For example when undertaking clinical research in a certain country, the regulators should not necessarily be from those countries but international bodies such as the International Conference on Harmonization.
Once the identified challenges are addressed, there are several benefits that can be associated with the practice. Specifically with the case of cancer research, it is increasingly becoming the practice that human subjects used in the studies get the advantage of receiving treatment with the research drugs first. This simply highlights the benefits of proximity when it comes to clinical research in such sensitive health areas a cancer. With the globalization of clinical research, the indication that is being drawn now is that patients in other parts of the world will now get the advantage to experience the benefits that proximity in clinical research presents. Also, as it has now become common that specific diseases such as Ebola and Zika Virus start from specific parts of the world, globalization of clinical research will pave way to get people directly affected by these to become human subjects.
- Laine C, Horton R, DeAngelis CD, Drazen JM, Frizelle FA, et al. (2009). Clinical trial registration — looking back and moving ahead. N Engl J Med 356, 2734–2736.
- Lang T, Cheah PY, & White NJ (2011). Clinical research: time for sensible global guidelines. Lancet 377, 1553–1555.
- Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, et al. (2009). Ethical and scientific implications of the globalization of clinical research. N Engl J Med 360, 816–823.