RFA-OD-19-018: Clinical Trials Development for Co-Occurring Conditions in Individuals with Down syndrome: Phased Awards for INCLUDE (R61/R33 Clinical Trials Required) - 0 views
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MiamiOH OARS on 12 Feb 19This FOA requests research applications to support development of clinical trials to treat critical and co-occurring health conditions in individuals with Down syndrome. The overarching emphasis is on the acquisition of knowledge that can be translated into new, enhanced, or tailored therapies for co-occurring conditions in individuals with Down syndrome. Applications should focus on delivering better healthcare outcomes and should seek solutions that are effective and deliverable. Research is needed to develop or test new and innovative adaptations of current drugs, interventions, and therapies for the treatment and management of co-occurring conditions in Down syndrome. These therapies should be implementable and sustainable in clinical settings beyond the research environment. Research applications may address a particular co-occurring condition at a particular stage of development or across the lifespan in people with Down syndrome. Outcomes research and health services research related to Down syndrome are also responsive to this FOA. Because some aspects of this research area are new for the trans-NIH scientific community, there will likely be a need to obtain preliminary data or conduct early-stage clinical trial preparatory activities before moving to a full-scale project. The Exploratory/Developmental Phased Innovation (R61/R33) grant mechanism is appropriate for this purpose. It provides opportunities for creating, developing, and strengthening new and necessary collaborations, as well as acquisition of preliminary data, and allows for milestone-driven research, supporting a phased research project with a stepped approach for implementation of a clinical trial.