Medications Development Clinical Trials Network for the Treatment of Alcohol Use Disorder - Contract Research Organization

治疗酒精使用障碍的药物开发临床试验网络 - 合同研究组织

• 批准号: 10506189
• 负责人: JANET RANSOM
• 金额: $ 196.74万
• 依托单位: FAST TRACK DRUGS AND BIOL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-11 至 2023-06-10
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10506189
• 关键词: Clinical Research; Clinical Trials; Clinical Trials Network; Contracts; Development; Good Clinical Practice; Logistics; Molecular Target; Monitor; National Institute on Alcohol Abuse and Alcoholism; Pharmaceutical Preparations; Pharmacotherapy; Preparation; Reporting; Research Contracts; Services; Shipping; Statistical Data Interpretation; United States Food and Drug Administration; alcohol abuse therapy; alcohol use disorder; clinical development; clinical research site; electronic data; meetings; operation; programs

Medications development is a high priority program at National Institute on Alcohol Abuse and Alcoholism (NIAAA). Currently, only three medications are approved by the Food and Drug Administration (FDA) for the treatment of alcohol use disorder (AUD). These medications have demonstrated small to moderate effect sizes in clinical trials and do not work for everyone, making the search for new molecular targets and more efficacious pharmacotherapies critical. The purpose of the current contract is to support a Contract Research Organization (CRO) to conduct all aspects of multiple, multi-center, pharmacotherapy clinical trials for the treatment of AUD.

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）仅批准了三种药物治疗酒精使用障碍（AUD）。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治疗至关重要。 当前合同的目的是支持合同研究组织（CRO）进行多个多中心药物治疗临床试验的所有方面，以治疗AUD。