Notice of Intent to Publish a Funding Opportunity Announcement for Multisite Clinical Trials: Leveraging Network Infrastructure to Advance Research and Outcomes for Women, Children, Pregnant and Lactating Individuals and/or Persons with Disabilities

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for multisite clinical research projects to be conducted using NICHD-supported clinical research network infrastructure. The goal of this FOA is to operationalize the previously reported NICHD guiding principles for multisite clinical trials delineated in Notice NOT-HD-19-034: To enhance the rigor and reproducibility of clinical trial protocols To promote greater availability of multisite clinical trial infrastructure to support trials from a wider range of investigators To facilitate data sharing and access to biospecimens to efficiently expand research capacity for all investigators To facilitate greater involvement of diverse populations in multisite clinical trials. To operationalize these principles, multisite clinical trials conducted via the participating NICHD-supported clinical research networks will now be submitted as investigator-initiated grant applications by any qualified investigator in the extramural community or by participating Network Clinical Center investigators through this FOA and will be reviewed by a NIH-convened peer review panel. It is the intent of this initiative to utilize the NICHD clinical research network infrastructure in a manner that will promote the funding and support of the best science in a timely, equitable and cost-effective manner. This FOA will support large scale, multisite clinical trials and observational studies that will leverage participating NICHD Networks (listed below). It is anticipated that additional Networks will be progressively added to this initiative. Single center, animal studies, basic science and basic experimental studies involving humans are beyond the scope of this initiative and will not be considered responsive. The scientific scope of this FOA is focused on specific areas of the NICHD mission and Strategic Plan, and the corresponding Networks that support those areas of study as depicted below. Thus, applications submitted in response to this FOA should address topics that align with one of the following Networks and their corresponding science: Maternal Fetal Medicine Units Network Neonatal Research Network Global Network for Women's and Children's Health Research Collaborative Pediatric Critical Care Research Network Pelvic Floor Disorder Network. if an investigator is considering another NICHD Network or area of science not directly aligned with the networks, please discuss with the NICHD scientific program contact. This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. The FOA is expected to be published in the Fall 2022 with the first expected application due date in the Spring 2023. This FOA will utilize the U01 activity code. Details of the planned FOA are provided below.
Categories: Health.