CORE FUNCTION ACTIVITIES - NICHD CCTN STATISTICAL AND CLINICAL COORDINATING CENTER

There is a demand for new methods of contraception that can provide effective protection against unintended pregnancy. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)’ s Contraceptive Clinical Trials Network (CCTN) is to develop protocols and conduct clinical trials that will assist in product development with the end goal to provide effective and safe contraception for women and men. The goal of the NICHD's CCTN is to systematically evaluate the safety and efficacy of new or existing female and male contraceptive drugs and devices as well as treatments of selected gynecologic conditions in Phase I, II, III and IV clinical trials conducted under Good Clinical Practices guidelines. The results of these clinical trials on new entities would be the basis for advancing candidate drugs and devices through clinical development with the ultimate goal of submission to the FDA in support of an Investigational New Drug (IND) application and initiation of New Drug Application (NDA) for a new drug for male or female contraception; and for a device, Premarket notification 510K, Premarket approval (PMA), and Investigation Device Exemption (IDE). SCOPE To provide statistical, clinical coordinating support and services to the CCTN and NICHD for a variety of tasks related to the development and conduct of clinical trials of male and female contraceptive products under Good Clinical Practices guidelines, as well as to provide if necessary ancillary services for the trials, such as product formulation, packaging, distribution, insurance and stability testing. Additional services supporting clinical evaluation and regulatory approval of candidate entities will be provided as needed for individual products.