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The use of MR imaging as an outcome measure in multiple sclerosis clinical trials.

机译:在多发性硬化症临床试验中使用MR成像作为结果指标。

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摘要

MR imaging is an integral part of multiple sclerosis (MS) clinical trials. It provides the primary efficacy outcome of preliminary proof-of-concept studies and important corroborating data as secondary and exploratory outcomes in pivotal trials. At all stages of drug development, MR imaging provides important information on the kinetics and magnitude of treatment effect and insight into potential mechanisms of action. Attention to issues in scan acquisition, quantitative image processing, and statistical analysis is critical to generate high-quality data. Although it is unlikely that one single outcome measure can capture all aspects of the MS disease process, there is potential for MR imaging outcomes to evaluate inflammatory and degenerative components within clinical trials.
机译:MR成像是多发性硬化症(MS)临床试验不可或缺的一部分。它提供了初步概念验证研究的主要疗效结果,以及作为关键性试验中次要和探索性结果的重要佐证数据。在药物开发的所有阶段,MR成像均可提供有关治疗效果的动力学和强度的重要信息以及对潜在作用机理的了解。注意扫描采集,定量图像处理和统计分析中的问题对于生成高质量数据至关重要。尽管不可能通过单一的结果指标来捕获MS疾病过程的所有方面,但在临床试验中,MR成像结果有可能评估炎症和退行性成分。

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