Key point of clinical research protocol design -- management of adverse event in post-marketing drug evaluation
Abstract：Drugs play important roles in citizens' physical and mental health. Pre-marketing trials have certain limitations resulting in incomplete safety profies; therefore, post-marketing drug evaluation is essential for further safety evaluation. Assessment of adverse reactions represents the most important measurement, the key approach and implementation element of which is the real world research and determination of management plan, respectively. In this paper, we discussed relevant laws and regulations, and ways to form an adequate management plan.
Keywords：DrugPost-Marketing EvaluationClinical trialReal World StudyRegistry StudyManagement Plan
Publication Date：2017-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：3( 520-522 )