真实世界证据支持药物研发? ——读真实世界证据支持药物研发征求意见稿的启示

2019-10-08 曾琳 临床流行病学和循证医学

真实世界研究、真实世界数据、真实世界证据、相信这三个名词我们的读者们都不陌生。真实世界这个概念近几年实在是太火了,以至于我们翻开一本期刊常常看到好几篇真实世界“冠名”的文章。今年五月二十九日药审中心发布了公开征求《真实世界证据支持药物研发的基本考虑》意见的通知(http://www.cde.org.cn/news.do?method=largeInfo&id=314865 支持下载相关文件

真实世界研究、真实世界数据、真实世界证据、相信这三个名词我们的读者们都不陌生。真实世界这个概念近几年实在是太火了,以至于我们翻开一本期刊常常看到好几篇真实世界“冠名”的文章。今年五月二十九日药审中心发布了公开征求《真实世界证据支持药物研发的基本考虑》意见的通知(http://www.cde.org.cn/news.do?method=largeInfo&id=314865 支持下载相关文件)。这个药物研发领域重磅消息马上引起了大量的关注,小编作为一个在临床研究方法中的一枚小青椒,一直都很关注真实世界研究相关的内容,也很快读到了这个信息,此后也听了些学界大牛(包括主要执笔人)讲相关内容,现在就和大家一起分享一下我的心得体会。

药审中心发布这个征求意见稿可以说紧跟了FDA以及EMA的脚步,同时有自己的创新,这其实是向产业界其释放了一个信号,即我国监管部门也将采纳真实世界证据来支持药物的研发和监管决策。比如在临床试验不可行或实施很困难的情况下,可以考虑利用真实世界证据来评价药物的有效性和安全性。在文中举了个实例,2018年批准的扩展贝伐珠单抗(Bevacizumab)联合以铂类为基础的化疗方案作为不可切除的晚期、转移性或复发性非鳞状非小细胞肺癌的患者的一线治疗。其中最重要的证据是三项回顾性研究,分析了患者的数据发现在含铂双药化疗基础上联合贝伐珠单抗较单纯化疗显着延长PFS和OS,与全球人群数据具有一致性,并且未发现新的安全性问题。也就是,药审部门对真实世界临床证据态度是开放的,而且已经在真实世界证据支持药物研发和评审中有很大的进步。

但毕竟小编更关心的是临床研究领域,悄悄告诉各位读者,如果对真实世界概念不太了解的话,可以好好读读这个征求意见稿,尤其推荐阅读参考文献后面的词汇表部分,会帮你瞬间get很多概念,如果对照文件正文来精读的话,估计你对真实世界概念的理解会上升好几个档次。当然咱们读这个文件的时候一定注意,这是药审部门从药物研发角度撰写的文件,其中有些名词的外延可能会局限在药物研发领域。但,并不是这个概念本身外延仅在药物研发中,其它的领域同样适用。比如:真实世界证据(Real-WorldEvidence,RWE)在文件中的解释是:通过对真实世界数据的分析获得的关于医疗产品的使用情况和潜在获益或风险的临床证据。在临床研究中,不见得真实世界证据都必须基于“医疗产品的使用”还可能是医疗政策的改变,健康管理策略的变化等等。因此如果咱们关注的是不仅是药物研发,而是更广泛的临床研究领域,咱们阅读这个文件时,对于各个概念的外延还需要延伸一下。

此外,小编读到了几个有意思的部分也许对我们真实世界临床研究有所启示,也和大家一起分享一下,一家之言欢迎讨论哈。先讲讲文件里的几个图:



图1从RWD到支持医疗产品监管决策RWE的路径

这个图1中红色的路径是从真实世界数据到真实世界证据并用于支持产品研发和监管决策的路径。细心的读者一定发现了,这里是经过几步筛选的。所谓临床的真实世界每时每刻都在产生大量数据,哪些数据被真实、准确、可靠的记录下来了,哪些数据测量工具是准确的,是否除了数据外还“携带”了其它必要的附属信息(数据测量时间、当时患者状态、检测的方法、单位等)决定了这些真实数据是否可用。在确定好可用的RWD后应考虑一下需要利用RWD来实现什么研究目的,其实是进一步筛选数据的过程,定位好目标患者群体再通过分析RWD产出RWE来支持药品研发。其实这提示我们所谓真实世界数据并不完美,甚至有可能不可用,在利用RWD时应从相关性、可靠性和数据标准等方面对数据质量和数据是否完整可用进行评估。此外,大家还应注意,图中标红的路径是最终为了支持药物研发和监管决策的路径。但基于潜在可用的RWD可以产出的RWE不仅仅只起这个作用,还可以帮助我们对疾病和健康有更为深入的认识,比如基于自然人群RWD可以用于探索病因和危险因素,临床人群的RWD分析可以用于探索预后的预测模型等等。

文件中另外两个图推荐了中药医院制剂的临床研发路径和策略

在小编看来,这些路径和策略不仅仅适用于中药医院制剂研发,在其它治疗性研究领域同样适用。比如有一种通过学科交叉方法创立的新手术方案已经在临床上有摸索和应用了,但是缺少足够的证据来明确这个术式的效果,影响了推广应用。这时可以针对已经采用这个术式的病例资料完成一个回顾性观察性研究(如回顾性队列),充分认识这个术式的适应症,可能的效果,然后开展前瞻性观察性研究,或者探索性RCT序贯确证性RCT,或者直接开展一个实用性RCT(PCT),来确定新术式的效果,并进行推广。其中采用哪种策略应根据回顾性研究的结果来结合新术式的成熟度来考虑。所以小编认为上图这两种策略和路径对非中药的其它干预性研究同样适用,很值得大家参考。

药审中心发布的这个征求意见稿相信药物研发领域的相关人员已经进行了深入的研读,但对其它临床研究者来讲,这个文件也有很好参考意义和价值,同样希望大家关注。除了小编分享的一点心得外,可以供大家参考和学习的地方还不少,以后再找机会和大家聊聊。

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    2020-08-28 14818eb4m67暂无昵称

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    2019-10-10 lqvr
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    2019-10-08 qingfengqishi5

    学习了,学习了

    0

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