心血管生物标记物与临床研究替代终点在药物注册方面的应用

摘要

Recent years, the possibility of biomarkers as a surrogate end-point in clinical trials of the drug development is discussed in many different therapeutic areas. Since 2003 , an international panel at the " Cardiovascular Biomarkers and Surrogate Endpoints Symposia" held in Bet-heada, Md, to discuss the use of biomarkers in the development of improved cardiovascular diagnostics and therapeutics. One purpose of the meeting is hoped to create efficiencies toward improved patient healthcare, accelerate drug development. The information presented in this article summarizes the perspective of different country's regulatory agencies in the cardiovascular biomarker and surrogate endpoints, hoping to give some reference for the domestic drug R and D and evaluator.%对于生物标记物可否在药物临床研究中作为替代终点,近年来在不同的治疗领域多有讨论,针对心血管生物标记物和替代终点,自2003年以来,每年在美国的贝塞斯达举办关于<心血管生物标记物与替代终点座谈会>,会议的目的之一,就是希望能够在改善患者健康方面提高效率,加快药物研发的速度.本文综述了在历次会议上各国政府药品注册管理部门针对心血管生物标记物、替代终点在药物评价方面的观点,供国内的药物研发与评价者参考.