【1.1】解读临床研究数据
随着我国药物自主研发实力的增强,近些年新药上市的品种越来越多。尤其肿瘤药物,新药更新迭代,为患者带来福音。那么面对芸芸众生的新药,如何评价这个药物的安全性有效性,无疑是需要通过新药评审时的药物临床试验的数据,除了由药企发起的RCT研究,还有研究者自己发起IIT研究,上市后的RWS研究,如何去做一个严谨的临床研究,研究结果能给更多的患者带来获益,除了研究方案的设计,研究中的疗效评价,数据解读和分析是至关重要的环节,那么如何使用疗效评价标准,每个临床终点代表的意义是什么?样本量如何计算?置信区间风险值又是什么意思?统计学如何解读?各种临床数据的图标怎么解读?今天笔者就带大家一起从最基础的概念学习一下:
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