Program Management Task

项目管理任务

• 批准号: 8948524
• 负责人: JANET RANSOM
• 金额: $ 19.32万
• 依托单位: FAST-TRACK DRUGS AND BIOLOGICS, LLC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-05-27 至 2015-05-26
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8948524
• 关键词: Alcohol dependence; Clinical Trials; Contractor; Contracts; Data; Data Coordinating Center; Development; Extramural Activities; Funding; Government; Human; Laboratory Study; Mission; Molecular Target; National Institute on Alcohol Abuse and Alcoholism; Pharmaceutical Preparations; Population; Protocols documentation; Review Literature; Site; Testing; Time; Translations; United States Food and Drug Administration; Work; alcohol use disorder; cost; experience; pre-clinical; programs; protocol development

Medications development is a high priority program at National Institute on Alcohol Abuse and Alcoholism (NIAAA). Currently, only 3 medications are approved by the Food and Drug Administration (FDA) for the treatment of alcohol dependence. These medications have demonstrated small to moderate effect sizes in clinical trials and do not work for everyone. Thus, the search for new molecular targets and more efficacious drugs is critical. The creation of the NIAAA Clinical Investigations Group (NCIG) program was recommended by the NIAAA Extramural Advisory Board on Medications Development, a subcommittee of Council, February 7-8, 2005 and subsequently approved by the full NIAAA National Advisory Council, June 2005. The Council recognized the urgent need for a rapid and efficient mechanism to conduct Proof-of-Concept (POC) trials of promising compounds to treat alcohol dependence. To carry out this mission, a contract mechanism was authorized to fund the NCIG program, which includes a Data Coordinating Center and a network of experienced clinical trial sites. The NIAAA has a mission to develop safe and effective medications to treat alcohol use disorder (AUD) in various populations. Part of the mission involves translation of the preclinical to human laboratory studies to ultimately clinical trials. II. SCOPE The purpose of this task order is to provide overall administrative and technical support for all other task orders issued under the IDIQ contract. The Government estimates the time necessary for the Contractor(s) to complete the tasks as outlined below, to be 12 months.

药物开发是国家酒精滥用和酒精中毒研究所 (NIAAA) 的一项高度优先计划。目前，只有 3 种药物获得美国食品和药物管理局 (FDA) 批准用于治疗酒精依赖。这些药物在临床试验中显示出小到中等的效果，并且并不适合所有人。因此，寻找新的分子靶点和更有效的药物至关重要。 NIAAA 临床研究小组 (NCIG) 计划的创建是由 NIAAA 药物开发校外咨询委员会（理事会的一个小组委员会）于 2005 年 2 月 7 日至 8 日建议建立的，随后于 2005 年 6 月得到 NIAAA 国家咨询委员会全体批准。理事会认识到迫切需要一种快速有效的机制来对治疗酒精依赖的有前景的化合物进行概念验证 (POC) 试验。为了完成这一使命，授权了一种合同机制来资助 NCIG 项目，其中包括一个数据协调中心和一个由经验丰富的临床试验站点组成的网络。 NIAAA 的使命是开发安全有效的药物来治疗不同人群的酒精使用障碍 (AUD)。任务的一部分涉及将临床前人体实验室研究转化为最终的临床试验。二.范围 该任务订单的目的是为根据 IDIQ 合同发布的所有其他任务订单提供全面的管理和技术支持。政府估计承包商完成下述任务所需的时间为 12 个月。