Clinical Trials Development for Co-Occurring Conditions in Individuals with Down syndrome: Phased Awards for INCLUDE (R61/R33 Clinical Trial Required)

The National Institutes of Health (NIH) is offering a grant opportunity for those interested in creating clinical trials for individuals with Down Syndrome. This project, called INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE), aims to enhance the health and quality of life for those with Down syndrome by addressing the health conditions that often accompany it.

Applications are invited for the Exploratory/Developmental Phased Innovation (R61/R33) grant to fund the development of these necessary clinical trials. The anticipated research should be guided by measurable, milestone-driven objectives.

The grant will cover a total project period of up to five years. An initial two-year phase (R61) is provided for preliminary, exploratory, and planning studies. This can potentially transition into a clinical trial stage (R33), with support for an additional three years.

However, it is important to note that despite the phases, the total duration of the entire grant, including both R61 and R33 stages, should not exceed five years. Moreover, the initial two-year R61 phase is dependent on established, measurable milestones.