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首页> 美国卫生研究院文献>Neuropsychopharmacology >The Alcohol Clinical Trials Initiative (ACTIVE): Purpose and Goals for Assessing Important and Salient Issues for Medications Development in Alcohol Use Disorders
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The Alcohol Clinical Trials Initiative (ACTIVE): Purpose and Goals for Assessing Important and Salient Issues for Medications Development in Alcohol Use Disorders

机译：酒精临床试验计划（ACTIVE）：评估酒精使用障碍药物开发中重要和突出问题的目的和目标

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Although progress has been made in the treatment of alcohol use disorders, more effective treatments are needed. In the last 15 years, several medications have been approved for use in alcohol dependence but have only limited effectiveness and clinical acceptance. While academics have developed some ‘standards' for the performance of clinical trials for alcohol dependence, they vary considerably, in the type of populations to be studied, the length of trials, salient outcome measures, and data analyses to be used (especially in the treatment of missing data). This variability impedes the commercial development of medications to treat alcohol dependence. Using a model similar to that used to develop an expert consensus for medications to improve cognitive aspects of schizophrenia (MATRICS) and in the treatment of pain (IMMPACT), a workgroup has been formed under the auspices of ACNP, known as the ACTIVE (Alcohol Clinical Trials Initiative) group, to evaluate data from completed clinical trials to develop a consensus on key issues in the conduct of clinical trials in alcohol dependence. ACTIVE consists of academic experts, industry representatives, and staff from the Food and Drug Administration, the National Institute on Alcohol Abuse and Alcoholism, and the National Institute on Drug Abuse. This paper describes the rationale behind the effort, its history and organization, and initial key questions that have been identified as the primary focus of the workgroup. Future papers will focus on knowledge gained from the re-analysis of completed trials and provide consensus opinions regarding the performance of clinical trials that might be undertaken in the future.
机译：尽管在戒酒方面已取得进展，但仍需要更有效的治疗方法。在过去的15年中，已经批准了几种药物用于酒精依赖，但疗效和临床接受度有限。尽管学者们已经为酒精依赖的临床试验制定了一些“标准”，但在所研究的人群类型，试验时间，显着性结果测量和要使用的数据分析方面，它们存在很大差异（尤其是在处理丢失的数据）。这种可变性阻碍了治疗酒精依赖药物的商业开发。使用类似于用于建立药物共识以改善精神分裂症认知方面（MATRICS）和治疗疼痛（IMMPACT）的模型，在ACNP的主持下已成立了一个工作组，被称为ACTIVE（酒精临床试验倡议组织），评估来自完成的临床试验的数据，以就酒精依赖临床试验的关键问题达成共识。活动由学术专家，行业代表以及食品和药物管理局，美国国家酒精滥用和酒精中毒研究所以及美国国家药物滥用研究所的工作人员组成。本文描述了工作背后的理由，其历史和组织以及最初的关键问题，这些问题已被确定为工作组的主要重点。未来的论文将集中于对完成的试验进行重新分析而获得的知识，并就未来可能进行的临床试验的性能提供共识。

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