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

RFA
Friday, December 13, 2019
Thursday, November 4, 2021
R61/R33
RFA-OD-20-003

Funding Opportunity Purpose

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.

Development of the INCLUDE (Investigation of Co-occurring Conditions across the Lifespan to Understand Down syndromE) Project Data Coordinating Center (U2C Clinical Trial Not Allowed)

RFA
Friday, December 13, 2019
Saturday, February 15, 2020
U2C
RFA-OD-20-007

Funding Opportunity Purpose

The objective of this FOA is to support the development of the Data Coordinating Center for the NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) project, which consists of the following components: a Data Portal Core, a Data Management Core, and an Administrative and Outreach Core. The goal of the web-based Data Portal is to accelerate discovery of etiology and biologic pathways underlying the comorbidities of Down syndrome by facilitating access to and querying of data from cohorts of individuals with Down syndrome. The Data Portal will facilitate access to aggregated and harmonized data to empower analyses among the Down syndrome research community, as well as the broader scientific community. The Data Management Core will work with INCLUDE investigators and other data generators to facilitate data collection, processing, and harmonization. The Administrative and Outreach Core will oversee administrative activities, work closely with a Steering Committee and INCLUDE program staff, and provide outreach and education to the research community on using the Data Portal.

Small Research Grants for Analyses of Down Syndrome-related Research Data for the INCLUDE Project (R03 Clinical Trial Not Allowed)

RFA
Friday, December 13, 2019
Thursday, November 4, 2021
R03
RFA-OD-20-006

Funding Opportunity Purpose

The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project seeks to improve health and quality-of-life for individuals with Down syndrome. This FOA is intended to support meritorious small research projects focused on analyses of genomic and other -omics datasets related to Down syndrome research, with an emphasis on elucidating the underlying etiologies of risk and resiliencies to co-occurring health conditions. Development of approaches, tools, or algorithms appropriate for analyzing data relevant to Down syndrome may also be proposed.

Jointly Sponsored Ruth L. Kirschstein National Research Service Award Institutional Predoctoral Training Program in the Neurosciences (T32 Clinical Trial Not Allowed)

PAR
Wednesday, December 11, 2019
Thursday, May 26, 2022
T32
PAR-20-076

Funding Opportunity Purpose

Reissue of PAR-17-096. The Jointly Sponsored NIH Predoctoral Training Program in the Neurosciences (JSPTPN) is an institutional program that supports broad and fundamental research training in the neurosciences. In addition to a broad education in the neurosciences, a key component will be a curriculum that provides a strong foundation in experimental design, statistical methodology and quantitative reasoning. JSPTPN programs are intended to be 2 years in duration and students may only be appointed to this training grant during the first 2 years of their graduate research training. The primary objective is to prepare students to be outstanding scientists equipped to pursue careers in neuroscience.

Clinical Trials Planning for Symptomatic Vascular Contributions to Cognitive Impairment and Dementia (VCID) (R34 Clinical Trial Not Allowed)

RFA
Wednesday, November 20, 2019
Wednesday, April 1, 2020
R34
RFA-NS-20-012

Funding Opportunity Purpose

This initiative will provide two years of support for planning activities necessary for initiating a Phase III clinical trial designed to validate VCID biomarkers and/or treat patients with VCID. The full spectrum of VCID is in scope, and the one or more VCID disorders(s) to be targeted in the trial must be clearly specified in the application, for example (but not limited to): vascular insults including clinical stroke, silent infarcts and microinfarcts, leukoaraiosis, cerebral amyloid angiopathy (CAA), transient ischemic attack (TIA), micro-bleeds, CADASIL, and vascular contributions to Alzheimers dementia. Planning activities may include identifying trial sites/collaborations, designing trial protocols and procedures, and addressing regulatory approvals.

NIH Blueprint Program for Enhancing Neuroscience Diversity through Undergraduate Research Education Experiences (BP-ENDURE) (R25 Clinical Trial Not Allowed)

RFA
Tuesday, November 19, 2019
Thursday, February 20, 2020
R25
RFA-NS-20-015

Funding Opportunity Purpose

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this NIH Blueprint R25 program is to encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical, behavioral, and clinical research workforce, to pursue further studies or careers in research. To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on Courses for Skills Development, Research Experiences, and Mentoring Activities. The fully integrated educational activities should prepare undergraduate students from diverse backgrounds, including those from groups underrepresented in biomedical and behavioral sciences to enter Ph.D. degree programs in the neurosciences. To accomplish this goal, this initiative will provide institutional awards to develop neuroscience research education programs comprised of collaborative partnerships integrated across different educational institution types. Each partnership must include: a) one or more institutions that either: 1) have a historical and current mission to educate students from any of the populations that have been identified as underrepresented in biomedical research as defined by the National Science Foundation NSF, see http://www.nsf.gov/statistics/wmpd/) (i.e., African Americans or Blacks, Hispanic or Latino Americans, American Indians, Alaska Natives, Native Hawaiians, U.S. Pacific Islanders, and persons with disabilities) or 2) have a documented track record of recruiting, training and/or educating, and graduating underrepresented students as defined by NSF (see above), which has resulted in increasing the institution's contribution to the national pool of graduates from underrepresented backgrounds who pursue biomedical research careers; b) a research-intensive institution that has an established neuroscience or neuroscience-related program; c) integrated

BRAIN Initiative Advanced Postdoctoral Career Transition Award to Promote Diversity (K99/R00 Independent Clinical Trial Not Allowed)

RFA
Thursday, November 14, 2019
Saturday, November 12, 2022
K99/R00
RFA-NS-19-043

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor. Applicants proposing a clinical trial or an ancillary study to an ongoing clinical trial as lead investigator, should apply to the companion FOA.

BRAIN Initiative Advanced Postdoctoral Career Transition Award to Promote Diversity (K99/R00 Independent Clinical Trial Required)

RFA
Thursday, November 14, 2019
Saturday, November 12, 2022
K99/R00
RFA-NS-19-044

Funding Opportunity Purpose

The purpose of the NIH BRAIN Initiative Advanced Postdoctoral Career Transition Award to Promote Diversity (K99/R00) program is to enhance workforce diversity in the neuroscience workforce and maintain a strong cohort of new and talented, NIH-supported, independent investigators from diverse backgrounds in BRAIN Initiative research areas. This program is designed to facilitate a timely transition of outstanding postdoctoral researchers with a research and/or clinical doctorate degree from mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. The program will provide independent NIH research support during this transition in order to help awardees to launch competitive, independent research careers. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary study to an existing trial, as part of their research and career development. Applicants not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion FOA.

Data Harmonization, Curation and Secondary Analysis of Existing Clinical Datasets (R61/R33 Clinical Trial Not Allowed)

RFA
Wednesday, October 30, 2019
Wednesday, March 18, 2020
R61/R33
RFA-NS-20-007

Funding Opportunity Purpose

This FOA invites applications from multidisciplinary teams to perform secondary data analysis, using existing datasets from two or more multi-site clinical research projects, to address scientific and clinical hypotheses relevant to neurological disorders and conditions within the NINDS mission. In this phased funding mechanism, applications are required to systematically and comprehensively perform cross-project data harmonization and curation, assessed using Go/No-go data-quality metrics, prior to funding of the second phase of data analyses. Consistent with the FAIR (findable, accessible, interoperable and reusable) data principles, this funding opportunity expects open-source cataloging of the processes and tools used for harmonization, curation, and analysis, as well as controlled access to the curated datasets.

Support of Competitive Research (SCORE) Pilot Project Award (SC2 - Clinical Trial Not Allowed)

PAR
Thursday, October 24, 2019
Thursday, September 8, 2022
PAR-20-040

Funding Opportunity Purpose

The SCORE Program is a developmental program designed to increase the research competitiveness of faculty and the research base at institutions with an explicitly stated historical mission and/or a demonstrated track record within the previous 10 years of training and graduating students from backgrounds underrepresented in biomedical research. Eligible institutions must award science degrees to undergraduate (B.S. or B.A.) and/or graduate students (M.S. or Ph.D.) and have received less than 6 million dollars per year of NIH R01 support (total costs) in each of the last 2 fiscal years.

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