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利用基于新技术的技术来改善临床试验中与酒精相关的结果。

Use of novel technology-based techniques to improve alcohol-related outcomes in clinical trials.

机构信息

Corresponding author: Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, NIAAA & NIDA, NIH, 10 Center Drive (10CRC/15330) MSC 1108, Room 1-5429, Bethesda, MD 20892-1108, USA.

出版信息

Alcohol Alcohol. 2013 Nov-Dec;48(6):712-9. doi: 10.1093/alcalc/agt134. Epub 2013 Aug 17.

Abstract

With a better understanding of the biologic basis of alcohol dependence and the considerable financial burden of alcohol abuse and dependence, the number of alcohol-related clinical pharmacotherapy trials has been on the rise. Subsequently, the potential to find efficacious treatments is more promising. Unfortunately, alcohol-related trials face a number of challenges, as a result of the difficulties that arise from traditional and outdated methods to collect data and ensure medication adherence. Novel technology-based assessments, such as ecological momentary assessment, interactive voice response, transdermal sensor and medication-event monitoring system provide a prospective solution-albeit not without possible concerns-to the difficulties faced in alcohol-related clinical trials. Clinical trials are meant to define the efficacy of the treatment and to determine an effective and safe dosage. However, due to lack of adherence a drug could inappropriately or mistakenly be judged as ineffective for treating a specific disorder. The described technologies may be important tools to prevent false negatives in validating drug efficacy, to provide consistency in clinical trials and to improve available data regarding the study of pharmacotherapies for alcohol dependence.

摘要

随着对酒精依赖的生物学基础的更好理解,以及对酒精滥用和依赖的巨大经济负担的认识,与酒精相关的临床药理学试验的数量一直在增加。因此,找到有效治疗方法的可能性更加有希望。不幸的是,由于收集数据和确保药物依从性的传统和过时方法所带来的困难,与酒精相关的试验面临着许多挑战。基于新技术的评估,如生态瞬时评估、交互式语音应答、透皮传感器和药物事件监测系统,为解决酒精相关临床试验中面临的困难提供了一个有前途的解决方案——尽管并非没有可能的担忧。临床试验旨在确定治疗的疗效,并确定有效和安全的剂量。然而,由于缺乏依从性,一种药物可能会被不恰当地或错误地判断为对治疗特定疾病无效。所描述的技术可能是防止在验证药物疗效时出现假阴性的重要工具,为临床试验提供一致性,并改善关于酒精依赖的药物治疗研究的现有数据。

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