Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea.
Korean J Intern Med. 2019 Sep;34(5):974-981. doi: 10.3904/kjim.2018.440. Epub 2019 Feb 18.
Clinical research is the study of aspects of patient health or illness that are closely related to clinical practice. In the late 20th and early 21th century, outcomes for patients with rheumatoid arthritis (RA) improved dramatically due to breakthroughs in new drugs. Patient-reported outcome measures now play a significant role in the drug development process as study endpoints in clinical trials of new therapies, and this has led to increased interest in the patient's perspective, drug safety and treatment outcomes in clinical practice. In accordance with these needs, many prospective cohorts for RA patients and registries of biologic disease modifying anti-rheumatic drugs have been actively conducted in the United States and European and Asian countries. A gradual shift is taking place in the major outcomes of clinical research using these prospective cohorts and registries. This article will introduce representative registries for RA in each country set up in the early 2000s and will discuss future perspectives in clinical research on RA patients using such clinical registries.
临床研究是对与临床实践密切相关的患者健康或疾病方面的研究。在 20 世纪末和 21 世纪初，由于新型药物的突破，类风湿关节炎（RA）患者的治疗效果显著改善。现在，患者报告的结局测量在新药临床试验的研究终点中扮演着重要的角色，这也使得人们对患者的观点、药物安全性和临床实践中的治疗结果越来越感兴趣。为了满足这些需求，在美国、欧洲和亚洲国家，许多针对 RA 患者的前瞻性队列研究和生物制剂治疗的登记研究已经在积极开展。这些前瞻性队列和登记研究的主要临床研究结果正在逐渐发生转变。本文将介绍 21 世纪初在每个国家设立的 RA 代表性登记研究，并讨论利用这些临床登记研究进行 RA 患者临床研究的未来展望。
