Harmonization in clinical trials
- Harmonization in clinical trials
Harmonization in Clinical Trials - The word Harmonization comes from Greek word "Harmonia" - the state of the matter or rules when all the parts are fit together. Harmonization is Global Standards that are widely accepted, this principle today is valid for many things.What does the international harmonization (or harmonize local standards to international standards) mean? It does not necessary mean that every body should accept a standard developed by Western countries. Rather than that, it should mean that every country must share the ownership of an international standard, and every body should equally benefit from the international standards.At least, when the harmonization in place, the international standards should be developed at first, and then, if necessary, national standards may be developed within the framework that is defined by the international standard.
How to make it as real? There are two key things to be noticed.
All countries must speak their requirement(s) up to the international discussion, at the early stage of the development of the international standard in an adequate form for the discussion like it was on ICH in 60-s.The only country that has technical/marketing advantage may take a leadership of the discussion and control of the resultant standards.
ee also
*International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
*Common Technical Document
*Clinical Data Interchange Standards Consortium
*Food and Drug Administration
*European Medicines Agency
*EudraLex
*European Clinical Research Infrastructures Network (ECRIN)
*Ministry of Health, Labour and Welfare (Japan)
*Clinical trial
*Double-blind
*Drug
*Drug design
*Drug discovery
*Effect size
*Exclusion criteria
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