真实世界临床研究是指在真实临床、社区或家庭环境下，获取多种数据，从而评价某种治疗措施对患者健康真实影响的研究。真实世界研究包括观察性真实世界研究和试验性真实世界研究，真实世界研究的纳入人群均为临床实际的患者群体，样本量通常较大。真实世界研究证据是随机对照研究证据的重要补充。真实世界研究的概念于1993年正式提出，近10余年来真实世界研究逐渐兴起，但我国真实世界研究的质量参差不齐，有待规范。为指导我国真实世界研究，本专家委员会撰写了本规范，以供临床研究相关人员参考。

Real world clinical studies refer to clinical studies conducted in real practice to evaluate effect of certain therapy on patients’ health. RWS data may be get from multiple sources which include hospital, community and home. Real world studies can be divided into observational studies and experimental studies. Real world studies always enrolled large sample size of real practice patients. In evidence based medicine system, evidence from real world studies are important supplement to evidence from randomized controlled studies. The concept of real world studies was literally reported in 1993 for the first time. Globally, real world studies develop rapidly in recent 10 years. Yet quality of real world studies in China still need to be improved. This practice algorithm on real world study were drafted to provide reference to related clinicians and researchers.