真实世界临床研究的分类和设计要点浅谈

Critical points of real world clinical study classification and design

真实世界研究是临床试验和药品上市后再评价药物疗效的一种现代医学研究新方法。作为临床研究的一种新形式,真实世界研究同样须遵循临床研究的一般原则,良好的设计、高质量的数据和可靠的统计方法能促使高质量真实世界证据的产生。随着信息化技术的发展和大数据时代的来临及医学研究数据的可及性和采集便捷性大幅提升,真实世界研究成为医学研究的热点之一。基于真实世界研究产生的真实世界证据提供了洞察药物和医疗器械在日常医疗实践中实际的使用方式、使用问题以及毒性和疗效结果的真实信息,这种研究方法及其产生的真实世界证据逐渐得到了临床医学领域专家的认可。

Real world study is a new modern medical approach for clinical trials and post-marketing re-evaluation of drug efficacy and must also follow the general principles of clinical research as a new form of clinical research.Good design,high-quality data and reliable statistical methods can lead to high-quality real world evidence.With the development of information technology and the advent of the era of big data as well as the significant improvement of the accessibility and collection of medical research data,real world study has become one of the hot spots in medical research.Real world evidence based on real world study can provide insight into the actual use of drugs and medical devices in daily medical practice as well as real information about the problems of their use,and the toxicity and efficacy outcomes,and this approach and the real world evidence generated by this research are gradually gaining recognition among experts in clinical medicine.