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

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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.