真实世界研究 : RWR与RCT的不同

2016-12-14 度衡之道 度衡之道微信号

真实世界研究与随机对照试验的比较 由于随机对照试验(RCT)在实际临床研究中存在一定的困难性,近年来真实世界研究(real world research, RWR)引起了医务工作者的关注。 RWR是指在较大的样本量(覆盖具有代表性的更广大受试人群)的基础上,根据患者的实际病情和意愿非随机选择治疗措施,并注重有意义的结局治疗。RWR与RCT的区别在于: 1、临床研究时期与研究目标:RCT关注的

真实世界研究与随机对照试验的比较

由于随机对照试验(RCT)在实际临床研究中存在一定的困难性,近年来真实世界研究(real world research, RWR)引起了医务工作者的关注。


RWR是指在较大的样本量(覆盖具有代表性的更广大受试人群)的基础上,根据患者的实际病情和意愿非随机选择治疗措施,并注重有意义的结局治疗。RWR与RCT的区别在于:

1、临床研究时期与研究目标:RCT关注的是效力研究,RWR关注效果研究。

2、研究时间及设计方案:RCT研究时间通常较短,以试验性方法为主;RWR一般进行较长观察的临床观察和随访,对健康结局有较好的评价。

3、研究质量控制手段: RCT可能产生限制结果的外推应用,影响结果的可行性,不符合临床实际的缺点。而RWR是一个非随机、开放性、不使用安慰剂的非盲试验,与现实临床更接近,无外推困难。

4、研究纳入和排除标准:RCT通常是在严格的纳入和排除标准下入选研究对象。其代表性及外部真实性有一定局限性。相比之下,RWR采用较宽泛纳入标准和较少的排除标准,获得一组与试验结果外推人群保持一致的受试者,大大减少了选择性偏倚。

5、样本量和代表性:对于RCT和RWR来说,样本量都是考察结果真实性的重要指标。RWR一般要求的样本量远大于RTC。

6、干预情况:RWR强调真实的治疗,RCT强调标准化的治疗。

7、结局测量指标与数据采集、管理及统计分析方法:RCT的结局测量多以一个或者一些特定病症或体征为评价目标,而RWR结局测量多采用有广泛临床意义的指标,更具临床实用价值。

如今,药品上市后真实世界临床研究已在世界兴起,其在医药行业的影响力将不容小觑。患者、医生、医疗保险提供方、监管者以及政策制定者都在努力寻求各种来自于特定人群药品使用的准确信息。而RWR则将成为药品临床应用、医保制定、临床路径等各方参考的重要依据,有望对未来医药行业产生深刻影响。而国内已经有具有前瞻性的企业开始在RWR研究布局,如益佰制药最近推进的艾迪注射液十万例RWR研究。研究创新的将真实世界研究与大数据研究的方法应用于中药抗肿瘤注射剂大品种上市后安全性再评价。计划在未来的两年中,整群抽样艾迪处方住院患者10万例,构建了大数据的采集分析系统,通过大数据进一步阐述中药注射剂上市后真实世界中的安全性及关键影响因素,提高临床药学学科建设以及临床药物应用的安全水平,也提升了产品生命周期。

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    2017-06-03 fhui

    开阔眼界了

    0

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    2016-12-21 虈亣靌

    谢谢分享,学习了

    0

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    2016-12-15 jet747

    都很重要,缺一不可

    0

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临床需求导向的科学研究——真实世界研究

真实世界研究(Real-world Study, RWS)是通过不经主观筛选或二次加工的方式收集客观存在于或必然产生于日常临床诊疗实践中的数据,根据不同的待解答方向,经统计分析获得相应的研究结果,借以提供最具指导性的循证依据,正所谓“取之于民,用之于民”。RWS的要义在于“非干预”,通常采取“非随机、非对照、非设盲”的研究设计,相较于随机对照试验(Randomized Controlled T