Multisite Clinical Research: Leveraging Network Infrastructure to Advance Research for Women, Children, Pregnant and Lactating Individuals, and Persons with Disabilities (U01 Clinical Trial Optional)

The Multisite Clinical Research grant aims to advance research for women, children, pregnant and lactating individuals, and persons with disabilities. This funding opportunity announcement (FOA) invites applications for both multisite clinical trials and observational studies. These should be developed together with NICHD Networks and will be conducted employing NICHD-supported Network infrastructure.

This FOA aims to put into practice the previously stated NICHD guiding principles for multisite clinical trials as outlined in Notice NOT-HD-19-034. It aims to improve the quality and reliability of clinical trial protocols. It also seeks to make multisite clinical trial infrastructure more widely available to a larger group of investigators. This way, data sharing and access to biospecimens can be facilitated, thus enhancing research capacity for all investigators. Additionally, it hopes to enable a greater participation of diverse groups in multisite clinical trials.

Therefore, multisite clinical trials and observational studies will be conducted by and within participating NICHD-supported Clinical Research Networks. These are to be submitted as investigator-initiated, multi-Principal Investigator (PI) grant applications. Any qualified investigator in the extramural community, including NICHD Network investigators, can submit these in collaboration with the respective NICHD Network Data Coordinating Center (DCC).

The aim of this initiative is to employ the NICHD Clinical Research Network infrastructure in a way that promotes the best science finding and funding. This should also be done in a timely, transparent, equitable, and cost-effective manner.