transision and completion clinical trial

过渡和完成临床试验

• 批准号: 8934769
• 负责人: JANET RANSOM
• 金额: $ 235.84万
• 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: 2014-06-10 至 2015-06-10
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8934769
• 关键词: Alcohol dependence; Annual Reports; Back; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Code; Collaborations; Contractor; Contracts; Cooperative Research and Development Agreement; Cortrosyn; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Set; Databases; Development; Drug Storage; Effectiveness; Enrollment; Extramural Activities; Funding; Good Clinical Practice; Graph; Human; Human Resources; Institutes; Internet; Laboratories; Laboratory Study; Lead; Logistics; Medical; Methods; Mission; Molecular Target; Monitor; National Institute on Alcohol Abuse and Alcoholism; Performance; Pharmaceutical Preparations; Pharmacy facility; Population; Preparation; Principal Investigator; Protocols documentation; Publications; Quality Control; Randomized; Reporting; Research Personnel; Safety; Secure; Serum; Services; Site; Standardization; Structure; System; Teleconferences; Testing; Translations; United States Food and Drug Administration; Update; Vendor; Visit; Work; alcohol use disorder; clinical research site; data management; drug distribution; electronic data; experience; follow-up; medication compliance; meetings; novel; pill; pre-clinical; programs; quality assurance; response

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. In June 2012, the NCIG 004 study was initiated under contract HHSN275200900005C for the purpose of evaluating the novel compound ABT-436, a vasopresson 1B antagonist manufactured and provided to NIAAA by AbbVie under a Cooperative Research and Development Agreement (CRADA). However, the study could not be finalized and it will be transitioned and completed under this Task Order. II. SCOPE The purpose of this Task Order is to continue the tasks associated with the completion of the NCIG 004 study.

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临床调查小组（NCIG）计划的创建是由NIAAA校园内药物开发咨询委员会推荐的，理事会小组委员会，2005年2月7日至8日，随后得到了Full NIAAA国家咨询委员会的批准，2005年6月。理事会认识到，迫切需要快速有效的机制进行概念验证（POC）试验，以治疗酒精依赖性。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。 2012年6月，NCIG 004研究是根据合同HHSN275200900005C启动的，目的是评估新颖的化合物ABT-436，这是Abbvie在合作研究和开发协议（CRADA）下制造并提供给NIAAA的Vasopresson 1B拮抗剂并提供给NIAAA的。但是，该研究无法完成，并且将在此任务订单下过渡和完成。 ii。范围此任务订单的目的是继续与NCIG 004研究完成相关的任务。