Discussion on problems in conducting the clinical trials on off-label use of drug
HUANG Xiao-quan
CHEN Shi-yao
Abstract：Off-label prescriptions are common in clinical practice, and its relative researches increase globally over time. However, a lot of problems remain in conducting the clinical trials on off-label drug use. The aim of this article was to discuss how to conduct clinical trials on off-label use of drugs and its remaining problems. The problems were discussed as follows: when to conduct the off-label drug clinical trial; the controversy about who should be the investigators; whether the CFDA (China Food and Drug Administration) license is required for conducting such trials; how to obtain the permission from Clinical Ethics Committee; how to register the clinical trials on off-label use of drug; how to gain the funding supports; how to have your patients' consent; how to select a suitable patient population; and how to conduct study design of clinical trial on off-label use of drug. Detailed interpretations were made into these questions. We hope to standardize the off-label medication, conduct the proper clinical trial on off-label drug use, and reduce the occurrence of adverse events.
Keywords：Off-labelClinical trialAnalysis
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( 60-62 )