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TFOS DEWS二期临床试验设计报告 TFOS DEWS II Clinical Trial Design Report

Novack GD, Asbell P, Barabino S, MVW B, Ciolino JB, Foulks GN, Goldstein M, Lemp MA,

期刊名称:The Ocular Surface

卷期:2017年第15卷第3期

关键词:
报告

摘要

摘要:干眼症创新的治疗的发展进程是不易的,而且只有相对较少的治疗方法在评估后允许投入市场。在这份报告中,小组委员会回顾了设计以及实施高质量试验的挑战,特别提到了干眼症患者在试验中出现的问题,并从干眼症治疗的规范角度方面做了介绍。小组委员会对相关文献进行了回顾,虽然有一些观察结果表明导致众多试验失败可能的原因,但没有单一的明显的原因,除了症状和体征之间相关性的缺乏。因此,如前所述,报告提倡进行高质量的研究,继续向前。对于未来研究的一个关键建议就是,与优质临床规范保持一致,包括对优质生产规范质量的临床试验材料的使用。报告还建议在设计、治疗和样本数量方面,要与临床试验治疗、研究目标和发展阶段相一致。对关键研究的其他建议是对结果评估和适当样本量的预先选择。

 

The development of novel therapies for Dry Eye Disease (DED) is formidable, and relatively few treatments evaluated have been approved for marketing. In this report, the Subcommittee reviewed challenges in designing and conducting quality trials, with special reference to issues in trials in patients with DED and present the regulatory perspective on DED therapies. The Subcommittee reviewed the literature and while there are some observations about the possible reasons why so many trials have failed, there is no obvious single reason other than the lack of correlation between signs and symptoms in DED. Therefore the report advocates for conducting good quality studies, as described, going forward. A key recommendation for future studies is conduct consistent with Good Clinical Practice (GCP), including use of Good Manufacturing Practice (GMP) quality clinical trial material. The report also recommends that the design, treatments, and sample size be consistent with the investigational treatment, the objectives of the study, and the phase of development. Other recommendations for pivotal studies are a priori selection of the outcome measure, and an appropriate sample size.


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