NIAAA Medications Development Data Coordinating Center

NIAAA 药物开发数据协调中心

• 批准号: 8065568
• 负责人: JANET H RANSOM
• 金额: $ 274.41万
• 依托单位: FAST-TRACK DRUGS AND BIOLOGICS, LLC
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-01-15 至 2011-07-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8065568
• 关键词: Alcohol dependence; Alcohol-Related Disorders; Alcohols; Clinical Treatment; Clinical Trials; Contractor; Contracts; Data Coordinating Center; Development; Disease; Effectiveness; Equipment; Government; Human Resources; Individual; Lead; Medical; Multi-Institutional Clinical Trial; National Institute on Alcohol Abuse and Alcoholism; Pharmaceutical Preparations; Phase II Clinical Trials; Process; Qualifying; Schedule; Services; alcohol use disorder; data management; drug candidate; drug development; novel; operation; programs

Pharamacotherapy holds much promise for treating alcohol dependence and alcohol-related disorders, and for offering more treatment options to a wider spectrum of alcohol dependent individuals. A major priority of NIAAA is to facilitate the discovery, development, and delivery of medications to treat alcohol use disorders and alcohol-related medical disorders. To accelerate lead compounds in the drug development process, NIAAA has established a Phase 2 clinical trials program, the NIAAA Clinical Investigations Group (NCIG), to demonstrate the preliminary effectiveness of medications. The purpose of this contract is to establish a Data Coordinating Center for the NCIG to conduct all aspects of multi-center clinical trials for the treatment of alcohol use disorders using novel drug candidates.

药物疗法在治疗酒精依赖和酒精相关疾病方面大有可为，并为更广泛的酒精依赖者提供更多的治疗选择。NIAAA的一个主要优先事项是促进治疗酒精使用障碍和与酒精相关的医疗障碍的药物的发现、开发和交付。为了加速药物开发过程中的先导化合物，NIAAA建立了一个第二阶段临床试验计划，即NIAAA临床研究小组(NCIG)，以证明药物的初步效果。这份合同的目的是为NCIG建立一个数据协调中心，以进行使用新型候选药物治疗酒精使用障碍的多中心临床试验的所有方面。