Harmonization of Terminology

Why is the effort to standardize the language used in reporting clinical trials (MedDRA) important to harmonization throughout the world?

As the clinically validated international medical terminology, MedDRA (Medical Dictionary Regulatory Activities) emphasizes the use of standardized terminology throughout the regulatory process for data entry, data retrieval, data evaluation, and data presentation from the pre-marketing to post-marketing stages. This harmonization of language used in reporting clinical trials throughout the world is important because it is able to offer support for multiple medical areas as it provides a classification for a wide range of clinical information. Universal harmonization and global standardization cuts across multinational pharmaceutical companies and regulatory agencies and is necessary for electronic data transfer throughout product life cycle. This avoids the distortions of translation and errors across countries while saving time as the need for translation or cross-referencing through products lifetime is eliminated. This has shaped the conduct of global clinical trials in that the standardized terminology allows for effective comparison of the frequency of adverse events between non-treatment and drug treatment groups. This has been achieved due to the aggregation of verbatim; the same treatment and medical terms, into groupings of medically meaningful references that can be reviewed, analyzed and communicated to the regulatory authorities.MedDRA allows verbatim terms to be reported consistently, accurately and without bias for purposes of statistical evaluation of medical data in ways that optimize and regulate global public health issues.

MedDRA has numerous advantages since it covers broad health data; it is applicable internationally; it is compatible with IT tools and systems; it has increased specificity; it is maintained externally and centrally; its structure can support both analysis and presentation; and most importantly, it is used and supported by both regulators and the industry.


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