STATUS DETERMINATION AND PRIORITIZATION OF PIPELINE PRODUCTS UNDERGOING CLINICAL TRIALS FOR MALE AND FEMALE CONTRACEPTION

正在进行男性和女性避孕临床试验的管道产品的状态确定和优先级

• 批准号: 10025430
• 负责人: CLINT DART
• 金额: $ 129.56万
• 依托单位: HEALTH DECISIONS, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-24 至 2023-09-23
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10025430
• 关键词: Archives; Clinical; Clinical Trials; Clinical Trials Network; Consultations; Contraceptive Agents; Contraceptive methods; Data; Data Analyses; Data Collection; Development; Evaluation; Female Contraceptive Agents; Future; Guidelines; Male Contraceptive Agents; Manuscripts; Methods; Mission; Monitor; Monitoring Clinical Trials; National Institute of Child Health and Human Development; Program Development; Protocols documentation; Research; Services; Site; Woman; men; programs; protocol development; success

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has a mission to develop safe and effective contraceptives for women and for men. The Contraceptive Clinical Trials Network (CCTN) was established to provide qualified sites to perform clinical trials of new products. HD serves as the coordinator of these clinical trials at sites that have been pre-qualified to conduct a variety of clinical trials. HD provides coordination of protocol development, clinical trial coordination and monitoring and data analysis for products that are currently in the Contraception Development Program developmental pipeline. The services needed for the activities described herein require a period of data evaluation including iterative data analysis, advisory consultation and regulatory review to reach a determination for the next stage of development or for archiving the information as required by regulatory guidelines. SCOPE To provide statistical and clinical coordination as well as monitoring of clinical trials, including services and support related to protocol completion, data collection, data analysis, manuscript development and regulatory summary document new products under development for contraception in women and men in order to determine status and prioritization for products in the CDP developmental pipeline.

尤尼斯·肯尼迪·施莱佛国家儿童健康和人类发展研究所（NICHD）的使命是为妇女和男子开发安全有效的避孕药具。建立了避孕药临床试验网络，为新产品的临床试验提供合格的地点。HD作为这些临床试验的协调者，在已经获得进行各种临床试验的资格预审的研究中心开展这些临床试验。HD为目前处于避孕开发计划开发管道中的产品提供方案开发、临床试验协调和监测及数据分析的协调。本文所述活动所需的服务需要一段时间的数据评估，包括迭代数据分析、咨询和监管审查，以确定下一阶段的开发或根据监管指南的要求存档信息。 范围 提供统计和临床协调以及临床试验监测，包括与方案完成、数据收集、数据分析、手稿开发和监管摘要文件相关的服务和支持，以确定CDP开发管道中产品的状态和优先顺序。