Jilin consensus on screening healthy subjects and safety evaluation after drug administration in clinical trials
Clinical Pharmacology Committee of Jilin Provincial Pharmacological Society
DING Yanhua
Abstract：Subject screening and safety evaluation are key to assuring the quality of drug clinical trials.The selection of eligible healthy subjects and the objective scientific assessment of their safety are crucial components of ensuring the quality of drug clinical trials.The progress of clinical trials and the validity of scientific conclusions depend on these two aspects.However,current practices in both areas face significant challenges.Firstly,the criteria for healthy subject inclusion have yet to be universally established,leading to variable judgments across different institutions.Secondly,the evaluation and analysis of subject safety often suffer from inconsistent scales and subjective assessments.Additionally,a lack of guiding rules and methods hinders the standardization of these processes.To promote uniformity and facilitate subject selection,safety evaluation,and analysis in drug clinical trials,the Clinical Pharmacology Committee of Jilin Pharmacology Society has compiled this consensus document to provide comprehensive guidelines for these problems.
Keywords：Healthy subjectsScreeningSafety evaluationConsensus
Publication Date：2024-01-28
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：11( 73-83 )