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）的一个高度优先项目。目前，只有3种药物被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表现出小到中等的效果，并不适用于所有人。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，随后于2005年6月获得整个NIAAA国家咨询理事会的批准。理事会认识到迫切需要一个快速有效的机制，对有希望治疗酒精依赖的化合物进行概念验证试验。为了完成这一使命，授权一个合同机制为NCIG项目提供资金，其中包括一个数据协调中心和一个经验丰富的临床试验中心网络。NIAAA的使命是开发安全有效的药物来治疗各种人群的酒精使用障碍（AUD）。部分的使命涉及临床前人类实验室研究，最终临床试验的翻译。二.范围本任务订单的目的是为IDIQ合同下发出的所有其他任务订单提供全面的行政和技术支持。政府估计承包商完成下述任务所需的时间为12个月。