title: [Importance of clinical trial design and standardized implementation in ophthalmology].
abstract: 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, practical 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.
authors.affiliation: Department of Ophthalmology, First People's Hospital,Shanghai Jiaotong University, Shanghai 200080, China (Email:drxuxun@sjtu.edu.cn).
authors.forename: Xun
authors.initials: X
authors.lastname: Xu
mesh_terms: D035843:Biomedical Research; D002986:Clinical Trials as Topic / Q000592:standards*; D015507:Drugs, Investigational; D006801:Humans; D009885:Ophthalmology; D012107:Research Design / Q000592:standards*
chemical_list: D015507:Drugs, Investigational