NIAAA Medications Development Data Coordinating Center

NIAAA 药物开发数据协调中心

• 批准号: 8513193
• 负责人: JANET RANSOM
• 金额: $ 107.76万
• 依托单位: FAST TRACK DRUGS & 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 2014-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8513193
• 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.

药物疗法对于治疗酒精依赖和酒精相关疾病以及为更广泛的酒精依赖者提供更多的治疗选择具有很大的希望。 NIAAA 的首要任务是促进治疗酒精使用障碍和酒精相关疾病的药物的发现、开发和交付。为了加速先导化合物的药物开发过程，NIAAA 建立了 2 期临床试验计划，即 NIAAA 临床研究组 (NCIG)，以证明药物的初步有效性。该合同的目的是为 NCIG 建立一个数据协调中心，以开展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各个方面。