摘要
临床试验是一种非常重要的医学研究方法，是转化医学的桥梁，其结果常常作为制定临床诊疗指南的科学依据。目前我国虽已在开展眼科临床试验方面积累了较多经验，但试验方案设计的科学性、规范性、伦理性仍存在一些问题，影响了研究结果的真实性和可靠性。因而，重视眼科临床试验的设计和实施管理是今后眼科临床试验的目标和发展方向。临床试验的设计应根据试验目的，遵循国际通用的伦理学准则和设计原则，重视随机化、盲法和对照设置，实施中应注意人员培训、管理和监察，尽可能减少方案偏离的发生和保证数据真实性。
Clinical trial is an important medical research method, as well as the bridge of translational medicine. The results of scientific evidences are useful to make clinical practice guidelines. At present, much experience of carrying out ophthalmology clinical trials has been obtained and achieved, but there are still some scientific, praetical and ethical problems to be solved, because of their impact on the authenticity and reliability of the results. Therefore, attaching great importance to design of the clinical research and implement of the standardization would be the goal and the development direction. Clinical trial design rely on objective, follow international design principles on the ethics, randomization, blinding and placebo setting. During the trial implementation, personnel training, project management and monitoring would help to reduce protocol deviation and ensure data authenticity.
出处
《中华眼科杂志》
CAS
CSCD
北大核心
2013年第6期481-483,共3页
Chinese Journal of Ophthalmology
关键词
临床试验
研究设计
临床方案
生物伦理学
Clinical trial
Research design
C｜inical protocols
Bioethics I
