Research and enlightenment on the drug clinical trial transparency system
YANG Li
TIAN Li-juan
LIN Lin
Abstract:The transparency of clinical trial data is of great significance for safeguarding the public drug safety and the right to know,maintaining medical ethics and promoting scientific and technological progress.This paper started from the introducing of the historical development of drug clinical trial data transparency and detailedly discussed the transparency models,categories,contents,as well as the disputes existed and settlement mechanisms based on the analysis and comparison of some representative countries' drug clinical trial data systems.Finally,in view of the development status and existing problems of drug clinical trial transparency in China,this paper put forward four proposals,including advancing the legislation,developing various transparency models,expanding transparency scope and establishing and perfecting the mechanisms of dispute settlement.
Keywords:drugclinical trial datatransparency
Publication Date:2017-01-01
Online Publishing Date:2026-08-14(First online date of this platform, not the publication date of the document)
Pages:9( 990-998 )
Chinese Journal of New Drugs

Chinese Journal of New Drugs

PKUISTIC
ISSN:1003-3734
Year, Vol.(Issue):2017,26(9)