The International conference on harmonization-Good clinical practice (ICH-GCP) was introduced in the clinical research studies in response to several violations of human rights preceding the 1996 institution of the ICH clinical research guidelines. Thus, the Declaration of Helsinki and Nuremberg code remained the key framework for the ICH-GCP guidelines (Vijayananthan, & Nawawi, 2007). The ICH-GCP guidelines, in all account, intend to reinstall public awareness in public health and at the same time emphasize the need in controlling and regulating clinical trials involving human participants as well as protecting the rights and integrity of human subjects (ICH, 1996). In addition, the ICH-GCP guideline intend to provide quality assurance on data collected and the reported results in clinical trials, ensuring that the data are credible, accurate and reproducible (Vijayananthan, & Nawawi, 2007). For these reasons, it generated the need to globalize and harmonize clinical trial such that data and results will be recognize and deemed valid across continents. However, the underlying problems are that the ICH-GCP interpretation can easily be changed from continent to continent or country to country since it is not a legally binding document (Woodin, Schneider, Kelly, & Pillemer, 2012).

After the conception of the ICH-GCP in 1996, Asia-Pacific nations generated their own interpretation version of the ICH-GCP guidelines based on the framework of the original guideline (Vijayananthan, & Nawawi, 2007). Nonetheless, the contending issue of implying different interpretation of the ICH-GCP guidelines despite the fact that there is a good intention to safeguard the well-being of human subjects, could stem from the guide’s lack of consistency and replications of opinion. Although, the idea of ICH-GCP guideline was to maintain a harmonized clinical research in such a way that it is useful in different countries. However, when there is so much divergence in health care values and interpretations, harmonization could be problematic. One such problem was outlined by Mueller, Scheflenberg, and Owens (2007) regarding the pneumococcal vaccine in Gambia, where majority of parents registering their children in the trial did not know that their children were participating in a clinical trial or were not properly informed. In addition, some of the key elements of the guideline may be lost in translation if adequate attention is not given to the status of cultural competence of the region, in question. Furthermore, the lack of stringent regulations and implementations of the ICH-GCP in some of the developing countries is a difficult challenge especially when a clinical trial is only meant for scientific knowledge or public health considerations, and not for approval purposes (Mueller, Scheflenberg, & Owens, 2007).

On average, clinical trials conducted in developing countries are not the same standard as in developed countries. In addition, the “regulatory guidelines” may not completely comply with the ICH guidelines mostly due to lack of experience and understanding of the standards”. Perhaps, the rise in the globalization of clinical trial is partly due to low number of subjects’ participation and high cost associated with clinical trial in developed countries (Glickman et. al., 2009). In addition, there is an act of negligence in setting the same ICH-GCP standard of care in developing countries by the sponsors mainly because the regional regulatory agency is not strict and robust in implementing clinical regulations.

Clinical trial is science and science for that reason has a universal concept, except for some few exception. For instance, a molecular composition of any investigational medicinal product will not change its characteristic profile just because researchers conducted a trial in developing countries instead of developed countries. However, parameters that are subjects to change are subject participant’s genomic diversity, environmental condition and cultural diversity to mention but a few. Therefore, in science a good scientific protocol or standard operating procedure (SOP) is one that will show reproducible data. Hence, if the ICH-GCP is representative of a good clinical research practice, any omission from the ICH-GCP will significantly affect the data and the outcome of the clinical trial. Therefore, it is the scientific obligation of the researcher to ensure that the protocols are well-written and followed as outlined in the clinical trial SOP. Moreover, the misguided norms of “misunderstanding of the ICH-GCP” guidelines will be of less concern if stringent regulations are followed regardless of where the research is being conducted, and by so doing, researchers may prevent senseless clinical malpractices such as the one perpetrated by Pfizer in Nigeria in 1996 with the Trovan antibiotics when the ICH-GCP guidelines were already in place (Cohen, 2009). This kind of situation is more than a lapse in standards, it is simply a bad science.

It is also important to note that, in 2008, 80% of the FDA approved drug application had their data generated from foreign clinical studies (Karlberg, 2011). However, it is not indicative that all the generated data basically came from developing countries. Nonetheless, the office of the Inspector General of the US Department of Health and Human Services indicated that the FDA inspect less than 1% of the clinical studies in general, and at the same time downgrade their findings 68% of the time (Levinson, 2010).

References

Cohen, A. (2009). Clinical Research Safety and Standards in Developing World Up to U.S

Levels. ACRO.Retrieve from http://www.acrohealth.org/clinical-research-safety-and-ethical-standards-in-developing-world-up-to-u.s.-levels.html.

Glickman, S., McHutchison, J., et.al. (2009). Ethical and scientific implications of the globalization of clinical research. The New England Journal of Medicine, 360(8), 816- 823. Retrieve from http://web.ebscohost.com.ezp.waldenulibrary.org/ehost/detail?sid= 3a093b21-3ddb-42b3- bc24960a26c66a87%40sessionmgr111&vid=1&hid=125&bdata=JnNpdGU9Z Whvc3QtbGl2ZSZzY29wZT1zaXRl#db=rzh&AN=2010198764

International Conference on Harmonization Expert Working Group. (1996). Guideline for good clinical practice E6(R1). Retrieved from http://www.ich.org/fileadmin/PublicWebSite /ICH _Products/ Guidelines/Efficacy/E6_R1/Step4/E6_R1Guideline.pd

Karlberg, J. (2011). Globalization of Clinical Trials. Research Practitioner, 12(4), 132-138. Retrieve from http://web.ebscohost.com.ezp.waldenulibrary.org/ehost/detail?vid=3&hid =125&sid=7e4f0c11-9b9e-460d-84fb-1b4172eac118%40sessionmgr112&bdata=JnNp dGU9ZWhvc3QtbGl2ZQ%3d%3d#db=rzh&AN=2011257658.

Levinson, D. (2010).Challenges to FDA’s ability to monitor and inspect foreign clinical trials. Retrieve from http://oig.hhs.gov/oei/reports/oei-01-08- 00510.pdf.

Mueller, J., Scheflenberg, D., & Owens, S. (2007). Third-World barriers: Getting past consent and ethical issues endemic in underserved populations to ensure quality GCP. Applied Clinical Trials, 16(10), 58–64. Retrieved from http://ezp.waldenulibrary.org/login? url=http:// search.ebscohost.com/login.aspx? direct=true&db=a9h&AN=27063 452&site=ehost-live&scope=site .

Vijayananthan, A., & Nawawi, O. (2007). The importance of Good clinicl practice guidelines and its role in clinical trials. Retrieve from http://www.biij.org/2008/1/e5/e5.pdf.

Woodin, K., Schneider, J., Kelly, M., & Pillemer, S. (2012). Regulation and good clinical practice. Retrieve from https://class.waldenu.edu/webapps/portal/frameset.jsp? tab_tab_group_id=_2_1&url=%2Fwebapps%2Fblackboard%2Fexecute%2Flauncher %3Ftype%3DCourse%26id%3D_1342087_1%26url%3D.