Harmonization of Terminology in Clinical Studies

The Idea introduced by the international conference on harmonization (ICH) in universalizing medical terminology in clinical trials is brilliant and very important. The concept of the medical dictionary for regulatory activity (MedDRA) according to the ICH is the facet in unifying and facilitating the sharing of regulatory information internationally for medicinal products use in humans (ICH, 2012). Therefore, standardizing medical terminologies and making it a universal language among medical professional makes it easier to communicate and transfer medical information from divergent cultural regions with minimal or no error. The use of MedDRA may also maintain the integrity of information transferred to sustain its intended meaning and objectives without losing most of its meaning in translation (Dombey, Hamrell, Woodin,  2012). For this reason, access to the MedDRA made it possible and easy for scientists to bridge cultural and language barrier while conducting globally validated and safe clinical trials (Wiktorowicz, 2003).

In addition, MedDRA will eliminate unintentional transfer of bias information among health professionals that may result in the absence of the MedDRA terminology definitions or due to interpretational error or lack of translational accuracy or multiple meaning definition of a word within a multicultural demographic region. In other words, if there is no MedDRA terminology, there are more chances to have translational error. Therefore, the introduction of MedDRA will lessen this risk. Nonetheless, understanding that there is no immunity for unintentional human errors is a very crucial factor, a reminder for continuous improvement of clinical research studies and standards. Thus , the introduction of MedDRA in clinical research protects public health practices globally and advances efficient use of research benefits across the globe.

References

Dombey,S., Hamrell,M., & Woodin, K. (2012).  International harmonization of clinical  research

.  Retrieve from http://sylvan.live.ecollege.com/ec/crs/default.learn?CourseID =6493792&Survey=1&47=10828390&ClientNodeID=984640&coursenav=1&bhcp=1.

International Conference on Harmonization. (2012).  MedDRA.  Retrieve from http://www. ich.org/products/meddra.html.

Wiktorowicz, M. E. (2003). Emergent patterns in the regulation of pharmaceuticals: Institutions and interests in the United States, Canada, Britain, and France. Journal of           Health Politics, Policy and Law, 28(4), 615–658. Retrieved from http://ezp.waldenulibrary .org/login?url =http://search.ebscohost.com/login.aspx?direct=true&db=a9h&AN =10769953&site=ehost-live&scope=site