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

尤尼斯·肯尼迪·施莱弗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。避孕临床试验网络(CCTN)的建立是为了提供合格的网站来进行新产品的临床试验。HD在已获得进行各种临床试验的预审资格的地点担任这些临床试验的协调人。HD为目前处于避孕开发计划开发流程中的产品提供方案开发、临床试验协调、监测和数据分析的协调。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、咨询咨询和监管审查，以确定下一阶段的发展或根据监管准则的要求将信息存档。 作用域 提供统计和临床协调以及对临床试验的监测，包括与方案完成、数据收集、数据分析、手稿编写和监管摘要文件编制有关的服务和支助，以便为妇女和男子开发新的避孕产品，以确定CDP开发流程中的产品的状况和优先顺序。

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.