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Zdrowie i gospodarka · 9.05.1997

International Conference on Harmonisation; Draft Guideline on Statistical Principles for Clinical Trials; Availability

The Food and Drug Administration (FDA) is publishing a draft guideline entitled ``Statistical Principles for Clinical Trials.'' The draft guideline was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guideline is intended to provide recommendations to sponsors and scientific experts regarding statistical principles and methodology which, when applied to clinical trials for marketing applications, will facilitate the general acceptance of analyses and conclusions drawn from the trials.

Source: Federal Register — Food and Drug AdministrationOpen original release →