{"title":"Best Practices for the Design of Clinical Trials Related to the Visual System.","authors":"Maureen G Maguire","doi":"10.1146/annurev-vision-093019-113930","DOIUrl":null,"url":null,"abstract":"<p><p>Clinical trials for conditions affecting the visual system need to not only conform to the guidelines for all clinical trials, but also accommodate the possibility of both eyes of a single patient qualifying for the trial. In this review, I present the interplay of the key components in the design of a clinical trial, along with the modifications or options that may be available for trials addressing ocular conditions. Examples drawn from published reports of the design and results of clinical trials of ocular conditions are provided to illustrate application of the design principles. Current approaches to data analysis and reporting of trials are outlined, and the oversight and regulatory procedures to protect participants in clinical trials are discussed.</p>","PeriodicalId":48658,"journal":{"name":"Annual Review of Vision Science","volume":" ","pages":"867-886"},"PeriodicalIF":5.0000,"publicationDate":"2021-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annual Review of Vision Science","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1146/annurev-vision-093019-113930","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2021/7/23 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"NEUROSCIENCES","Score":null,"Total":0}
引用次数: 0
Abstract
Clinical trials for conditions affecting the visual system need to not only conform to the guidelines for all clinical trials, but also accommodate the possibility of both eyes of a single patient qualifying for the trial. In this review, I present the interplay of the key components in the design of a clinical trial, along with the modifications or options that may be available for trials addressing ocular conditions. Examples drawn from published reports of the design and results of clinical trials of ocular conditions are provided to illustrate application of the design principles. Current approaches to data analysis and reporting of trials are outlined, and the oversight and regulatory procedures to protect participants in clinical trials are discussed.
期刊介绍：
The Annual Review of Vision Science reviews progress in the visual sciences, a cross-cutting set of disciplines which intersect psychology, neuroscience, computer science, cell biology and genetics, and clinical medicine. The journal covers a broad range of topics and techniques, including optics, retina, central visual processing, visual perception, eye movements, visual development, vision models, computer vision, and the mechanisms of visual disease, dysfunction, and sight restoration. The study of vision is central to progress in many areas of science, and this new journal will explore and expose the connections that link it to biology, behavior, computation, engineering, and medicine.
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