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.

药物开发是美国国家酒精滥用与酒精中毒研究所（NIAAA）的高优先计划。目前，食品药品监督管理局（FDA）仅批准3种药物来治疗酒精依赖。这些药物在临床试验中表现出很小至​​中度的效应大小，并且不适合所有人。因此，寻找新的分子靶标和更有效的药物至关重要。 NIAAA AAA药物外咨询委员会推荐了NIAAA临床调查小组（NCIG）计划的创建计划，该计划是在2005年2月7日至8日，理事会小组委员会的小组委员会，并由全NIAAA国家咨询委员会批准，随后由2005年6月的NIAAA国家咨询委员会批准，该理事会认可了迫切需要进行的证明，并进行了良好的调查（poc）。依赖。为了执行此任务，合同机制被授权为NCIG计划提供资金，该计划包括数据协调中心和经验丰富的临床试验地点网络。 NIAAA的使命是开发安全有效的药物来治疗各种人群中的酒精使用障碍（AUD）。该任务的一部分涉及将临床前向人类实验室研究转换为最终临床试验。 ii。范围此任务订单的目的是为IDIQ合同发布的所有其他任务订单提供总体行政和技术支持。政府估计承包商完成以下概述的任务所需的时间为12个月。