摘要
目的为推进我国药物临床试验受试者补偿机制的建立提供参考和意见。方法探讨了美国对药物临床试验中的受试者损害责任的认定和补偿方案,并结合从中受到的启示为我国药物临床试验受试者补偿的实际情况提出建议。结论在借鉴美国的受试者补偿方案的同时,建立具备我国自身特色的补偿机制,促进我国临床试验质量管理规范的切实实行。
Objective To give advice and reference for establishment of compensation mechanism of drug clinical trial sub- jects in China. Methods The drug clinical trials to the subjects＇ impairment of the determination and compensation scheme liability in USA were discussed. The suggestions to the compensation for participant in China were put forward according to the experiences in USA and the actual situation in China. Conclusion The compensation mechanism in our country must be established in reference to the U- nited States, which could promote the quality control standard for clinical trials the practical implement.
出处
《药学实践杂志》
CAS
2013年第4期271-272,276,共3页
Journal of Pharmaceutical Practice
