MedDRA vs. WHO Drug: Comparing Clinical Coding Systems
This paper examines three major systems used to code and classify data in pharmaceutical research: MedDRA (Medical Dictionary for Regulatory Activities), WHO Drug, and the Clinical Data Interchange Standards Consortium (CDISC). It explains how MedDRA serves as a globally validated terminology for classifying adverse events throughout all phases of drug development, while WHO Drug functions primarily as a reference dictionary for existing medicinal products. The paper also explores how CDISC works as an overarching standardization body aimed at improving data interoperability across international clinical studies. Key distinctions between the systems are highlighted, along with the ongoing challenges of cross-cultural terminology translation in multinational research.
- Introduction to Clinical Data Coding: Why standardized coding matters in drug evaluation
- MedDRA: Adverse Event Classification: MedDRA's role in global drug development terminology
- WHO Drug: Medicinal Product Dictionary: WHO Drug as a medicinal product classification system
- Practical Applications in Clinical Trials: How MedDRA and WHO Drug are used together in trials
- CDISC and the Push for Global Standardization: CDISC's mission to unify clinical research data exchange
- Conclusion: Cross-cultural terminology as key remaining challenge
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What makes this paper effective
- Clear definitional structure: each coding system is introduced with a direct quotation from an authoritative source before being analyzed, grounding claims in evidence.
- Comparative logic: the paper consistently contrasts MedDRA and WHO Drug rather than describing them in isolation, making differences concrete and memorable.
- Practical illustration: the antidepressant trial example (herbal medications coded via WHO Drug vs. side effects coded via MedDRA) makes abstract distinctions tangible.
Key academic technique demonstrated
The paper demonstrates disciplined source integration — each system is defined using a direct quotation from official documentation, then contextualized with analytical commentary. This shows how to use primary/institutional sources to anchor factual claims before applying independent reasoning.
Structure breakdown
The paper opens with a rationale for standardized coding, then devotes a paragraph each to MedDRA and WHO Drug definitions before comparing their functions in practice. A final section introduces CDISC as a meta-level standardization effort. The conclusion is implicit, embedded in the discussion of multicultural terminology challenges. Approximately 500 words; suitable as a focused undergraduate overview paper.
Introduction to Clinical Data Coding
Standardized comparisons are essential when evaluating a new drug. Understanding a drug's efficacy relative to other drugs on the market — and placing any adverse events in proper perspective — requires an effective and uniform system of comparative analysis. "Coding of patient data is critical in the grouping, analysis, and reporting of data. Coding decisions directly impact submissions for New Drug Applications (NDAs), safety surveillance, and product labeling" (Truong & Li, 2007, p. 1). This paper reviews several of the most popular methods of coding data, specifically MedDRA and WHO Drug, and examines their unique and specific uses. It also assesses attempts to provide greater standardization to the system of conducting research trials.
MedDRA: Adverse Event Classification
MedDRA (Medical Dictionary for Regulatory Activities) is the "globally accepted, clinically validated medical terminology used within all phases of the drug development process, including classification of medical events for clinical trials and drug safety" ("Frequently Asked Questions — MedDRA," 2016). It has been translated into a wide variety of international languages and allows for relatively standardized comparisons across a variety of potential issues that may arise pre-testing, during clinical trials, and after a drug has been approved for the marketplace. MedDRA is specifically designed to facilitate analysis and comparison of drugs currently under testing or in their nascent stages of acceptance, particularly when adverse events occur.
WHO Drug: Medicinal Product Dictionary
In contrast, WHO Drug coding is primarily used as a classification system for existing drugs and other pertinent medical treatments. "WHO Drug is a dictionary of medicinal product information. It is used to identify drug names and provides information about a drug's active ingredients and its therapeutic use(s)" ("Frequently Asked Questions — WHO Drug," 2016). WHO Drug has the ability to classify drugs but is more limited than MedDRA in terms of classifying adverse events, and thus is of less utility in coding a drug trial. However, as a dictionary of drug information, "WHO Drug is the de-facto standard within the biopharmaceutical industry for classifying drugs, including prescription drugs, over-the-counter (OTC) medicines, herbal remedies, blood products, diagnostic substances, and biotech products" ("Frequently Asked Questions — WHO Drug," 2016).
Conclusion
MedDRA, WHO Drug, and CDISC each serve distinct but complementary roles in the pharmaceutical research ecosystem. MedDRA provides a validated framework for classifying adverse events throughout drug development, WHO Drug serves as the industry standard for identifying and cataloguing medicinal products, and CDISC works at a higher level to harmonize how clinical data are collected and shared globally. Addressing the remaining cross-cultural and cross-linguistic terminology challenges will be critical to achieving truly standardized and comparable international clinical research.
References
Frequently Asked Questions — MedDRA. (2016). Retrieved from http://www.thesisinc.com/faq-meddra.html#1
Frequently Asked Questions — WHO Drug. (2016). Retrieved from http://www.thesisinc.com/faq-whodrug.html#1
Mission and principles. (2016). CDISC. Retrieved from
Nagai, Y. (2012). Impacts of the CDISC standards on our clinical study operation: Lessons and current achievements — CDISC project team at Translational Research Informatics Center. Retrieved from http://www.cdisc.org/system/files/all/article/application/pdf/20121210_cdisc_news_letter_nagai_new_edits.pdf
Truong, S., & Li, N. (2007). Can coding MedDRA and WHO Drug be as easy as a Google search? SAS Global Forum, Paper 158-2007. Retrieved from http://www2.sas.com/proceedings/forum2007/158-2007.pdf
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