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Transformative Research Award for the INCLUDE (Investigation of Co-occurring Conditions across the Lifespan to Understand Down syndrome) Project (R01 Clinical Trial Not Allowed)

Funding Opportunity RFA-OD-19-016 from the NIH Guide for Grants and Contracts. The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project is soliciting applications for this Request for Applications (RFA) for Transformative R01 to support individual scientists or groups of scientists proposing groundbreaking, exceptionally innovative, original, and/or unconventional research with the potential to create new scientific paradigms, establish entirely new and improved clinical approaches, or develop transformative technologies. Applications from individuals with diverse backgrounds and in any topic relevant to Down syndrome research are welcome. Little or no preliminary data are expected. Projects must clearly demonstrate the potential to produce a major impact in research related to Down syndrome.

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

Funding Opportunity RFA-OD-19-018 from the NIH Guide for Grants and Contracts. This funding opportunity announcement (FOA) encourages Exploratory/Developmental Phased Innovation (R61/R33) grant applications to support development of clinical trials to treat critical and co-occurring health conditions in individuals with Down syndrome. The proposed research aims should be milestone-driven. The total project period for an application submitted in response to this FOA may not exceed five years. This FOA provides support for up to two years (R61 phase) for preliminary/developmental/planning studies, followed by possible transition of up to four years of expanded clinical trial support (R33), although the total duration of the award may not exceed five years. This FOA requires measurable R61 milestones.

INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Clinical Trial Readiness (R21 Clinical Trial Not Allowed)

Funding Opportunity RFA-OD-19-015 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) invites researchers to submit applications for support of clinical projects that address critical needs for clinical trial readiness in Down syndrome. The initiative seeks applications that are intended to facilitate Down syndrome research by enabling efficient and effective movement of candidate therapeutics or diagnostics towards clinical trials for Down syndrome and its co-occurring conditions, and to increase their likelihood of success through development and testing of biomarkers and clinical outcome assessment measures, development and testing of novel trial methods and recruitment strategies, or by defining the presentation and course of the co-occurring conditions in individuals with Down syndrome to enable the design of future clinical trials.

Biology of Bladder Cancer (R21 Clinical Trial Optional)

Funding Opportunity PAR-19-184 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) solicits applications investigating the biology and underlying mechanisms of bladder cancer. Bladder cancer is a significant health problem both in the United States and globally. Because of the high incidence and frequent tumor recurrence, bladder cancer exacts an outsized medical burden. While recent progress has been made in the molecular profiling of bladder cancers and identification of mutated genes, relatively little is known regarding the molecular mechanisms driving initiation, progression, and malignancy of bladder cancer. Furthermore, our understanding of biological processes of the normal bladder at the molecular, cell and organ levels is limited. Fundamental knowledge of how molecular and cellular functions of the bladder are altered in cancer will aid our understanding of bladder cancer biology and interventions. Applications that involve multidisciplinary teams and use clinical specimens or investigate both normal and cancer processes are encouraged.

Biology of Bladder Cancer (R01 Clinical Trial Optional)

Funding Opportunity PAR-19-183 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) solicits applications investigating the biology and underlying mechanisms of bladder cancer. Bladder cancer is a significant health problem both in the United States and globally. Because of the high incidence and frequent tumor recurrence, bladder cancer exacts an outsized medical burden. While recent progress has been made in the molecular profiling of bladder cancers and identification of mutated genes, relatively little is known regarding the molecular mechanisms driving initiation, progression, and malignancy of bladder cancer. Furthermore, our understanding of biological processes of the normal bladder at the molecular, cell and organ levels is limited. Fundamental knowledge of how molecular and cellular functions of the bladder are altered in cancer will aid our understanding of bladder cancer biology and interventions. Applications that involve multidisciplinary teams and use clinical specimens or investigate both normal and cancer processes are encouraged.

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