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Real-world Evidence versus Randomized Controlled Trial: Clinical Research Based on Electronic Medical Records

机译:真实证据与随机对照试验:基于电子病历的临床研究

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摘要

Real-world evidence (RWE) and randomized control trial (RCT) data are considered mutually complementary. However, compared with RCT, the outcomes of RWE continue to be assigned lower credibility. It must be emphasized that RWE research is a real-world practice that does not need to be executed as RCT research for it to be reliable. The advantages and disadvantages of RWE must be discerned clearly, and then the proper protocol can be planned from the beginning of the research to secure as many samples as possible. Attention must be paid to privacy protection. Moreover, bias can be reduced meaningfully by reducing the number of dropouts through detailed and meticulous data quality management. RCT research, characterized as having the highest reliability, and RWE research, which reflects the actual clinical aspects, can have a mutually supplementary relationship. Indeed, once this is proven, the two could comprise the most powerful evidence-based research method in medicine.
机译:实际证据(RWE)和随机对照试验(RCT)数据被认为是相互补充的。但是,与RCT相比,RWE的结果继续被赋予较低的可信度。必须强调的是,RWE研究是一种现实世界的实践,为了使其可靠,不需要作为RCT研究执行。必须清楚地认识到RWE的优缺点,然后可以从研究开始就计划适当的协议,以确保尽可能多的样本安全。必须注意隐私保护。此外,可以通过详细而细致的数据质量管理来减少丢失的数量,从而有意义地减少偏差。 RCT研究具有最高的可靠性,而RWE研究则反映了实际的临床情况,可以有相互补充的关系。确实,一旦证明了这一点,两者就可以构成医学上最有力的基于证据的研究方法。

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