摘要
目的:探讨政府、企业和学术界三方合作促进中国药物流行病学发展的必要性和可行性。方法和结果:讨论政府、企业、学术界在药物流行病学研究领域合作的重要性,介绍世界范围内可借鉴的合作经验,商榷我国开展药物流行病学研究三方合作的机遇与挑战以及需要注意的问题。结论:欧美国家在药物流行病学研究中,三方合作合理运用药物流行病学进行药物疗效和安全评价工作发挥了积极作用。针对我国特定的机遇和挑战,政府、企业和学术界三方的有效合作可充分发挥各自的优势,从而促进药物流行病学研究人才培养,医疗信息资源开发和制定有关的法律法规,并最终推动这一学科在中国的进一步发展。
Objective :To review the need for effective collaboration between government, industry and academia to maximize the use of pharmacoepidemiology in China. Method and Result:The significance of pharmacoepidemiology in the context of drug benefit-risk assessment in China were described, several successful collaborative programs between government (regulatory authorities), industry and academia in the United States (US) and European Union (EU) were reviewed and challenges and opportunities for three-party collaboration in China were examined. Collaboration between regulatory anthorities, industry and academia in the use of pharmacoepidcmiology has had some positive and effective outcomes in the US and EU. Conclusion:With an effective working partnership between government, industry and academia, pharmacoepidemiological research and drug safety evaluation can be enhanced through the implementation of appropriate regulations and guidelines, use of available health information resources, pharmacoepidemiological research experts, and training programs.
出处
《药物流行病学杂志》
CAS
2011年第1期6-10,共5页
Chinese Journal of Pharmacoepidemiology
关键词
药物流行病学
药物疗效
药物安全评价
Pharmacoepidemiology
Drug effectiveness
Drug safety assessment