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U.S.-China Program for Biomedical Collaborative Research (R01 Clinical Trial Optional)

RFA
Wednesday, January 2, 2019
Friday, February 22, 2019
R01
RFA-CA-19-009

Funding Opportunity Purpose

The purpose of the U.S.-China Program for Biomedical Collaborative Research is to stimulate collaborative basic, translational, and clinical research between United States (U.S.)-based researchers and Chinese researchers in the areas of cancer, environmental health, heart disease, blood disorders, diseases of the eye and visual system, mental health, and neurological disorders. Partnering U.S. and Chinese investigators must work jointly to submit identical applications to NIH and National Natural Science Foundation of China (NSFC), respectively. U.S. investigators must respond to the announcement from NIH, including the Chinese application as an attachment, and Chinese investigators must respond to a separate funding announcement from NSFC, including the NIH application as an attachment.

Center without Walls for PET Ligand Development for Alzheimer's disease related dementias (ADRDs) (U19 Clinical Trial Optional)

RFA
Tuesday, December 11, 2018
Thursday, February 14, 2019
U19
RFA-NS-19-014

Funding Opportunity Purpose

This funding opportunity announcement (FOA) supports the development of PET radioligands that identify proteinopathies or pathological processes associated with the human biology of Alzheimer's disease related dementias (ADRDs). Activities supported under this FOA include, but are not limited to the in vitro screening of existing ligands against human ADRD brain tissue, medicinal chemistry support for development of new compounds and improvement of existing ligand specificity and selectivity, initial screening of ligands in appropriate animal models, and radioligand formulation and first-in-human testing. The Center without Walls should encompass research that will move promising ligands through in vitro and in vivo optimization to first-in-human studies. Applications must include an administrative core, a medicinal chemistry core, a clinical core, a scientific governance structure, and a minimum of two research projects with milestone plans that address workflows for screening of existing and newly derived ligands against human ADRD tissue and appropriate animal models. Synergy must be evident among Center research projects and cores, such that successful completion of the aims could not be accomplished without the Center structure. This FOA is in response to the Alzheimer's Disease Related Dementias (ADRD) challenges outlined in the 2016 update to the National Plan to Address Alzheimer's Disease.

HEAL Initiative: Early Phase Pain Investigation Clinical Network - Clinical Coordinating Center (U24 Clinical Trial Not Allowed

RFA
Monday, December 10, 2018
Thursday, February 7, 2019
U24
RFA-NS-19-023

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to invite applications for the Clinical Coordinating Center (CCC) of the Early Phase Pain Investigation Clinical Network (EPPIC-Net). EPPIC-Net will serve as the cornerstone of the NIHs Helping to End Addiction Long-term (HEAL) Partnership. EPPIC-Net will provide a robust and readily accessible infrastructure for carrying out in-depth phenotyping and biomarker studies in patients with specific pain conditions, and the rapid design and performance of high-quality Phase 2 clinical trials to test promising novel therapeutics for pain from partners in academia or industry. Studies will bring intense focus to patients with well-defined pain conditions and high unmet therapeutic needs. EPPIC-Net will consist of one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC) and approximately 10 specialized clinical centers (Hubs). The CCC will both help design and facilitate the implementation of clinical trials and studies. This FOA solicits applications for EPPIC-Net CCC. Separate FOAs have been issued to solicit applications for the Data Coordinating Center (RFA-NS-18-035) and Specialized Clinical Centers (RFA-NS-18-037). Clinical trials conducted through EPPIC-Net may come from a variety of sources including the HEAL Partnership or from separate NIH funding announcements.

HEAL Initiative: Early Phase Pain Investigation Clinical Network - Data Coordinating Center (U24 Clinical Trials Not Allowed)

RFA
Monday, December 10, 2018
Thursday, February 7, 2019
U24
RFA-NS-19-024

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to invite applications for the Data Coordinating Center (DCC) of the Early Phase Pain Investigation Clinical Network (EPPIC-Net). EPPIC-Net will serve as the cornerstone of the NIHs Helping to End Addiction Long-term (HEAL) Partnership. EPPIC-Net will provide a robust and readily accessible infrastructure for carrying out in depth phenotyping and biomarker studies in patients with specific pain conditions, and the rapid design and performance of high-quality Phase 2 clinical trials to test promising novel therapeutics for pain from partners in academia or industry. Studies will bring intense focus to patients with well-defined pain conditions and high unmet therapeutic needs. EPPIC-Net will consist of one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC) and approximately 10 specialized clinical centers (hubs). As the main data manager for pain research in the HEAL Initiative, the EPPIC-Net DCC will host and manage clinical, neuroimaging, biomarker, omics, and preclinical data from EPPIC-Net and other components of the HEAL Initiatives pain research program. The DCC will also make these data and clinical biosamples available to the research community to advance the science of pain. Lastly,the DCC will provide leadership in the statistical design and analysis of EPPIC-Net studies, and the systems and processes for data collection, management, quality assurance and reporting. This FOA solicits applications for the EPPIC-Net Data Coordinating Center (DCC). Separate FOAs have been issued to solicit applications for the Clinical Coordinating Center (RFA-NS-18-036) and Specialized Clinical Centers (RFA-NS-18-037). Clinical trials conducted through EPPIC-Net may come from a variety of sources including the HEAL initiative, as described above, or from separate NIH funding announcements.

HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trial Not Allowed)

RFA
Monday, December 10, 2018
Thursday, February 7, 2019
U24
RFA-NS-19-025

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to invite applications for the Specialized Clinical Centers (hubs) of the Early Phase Pain Investigation Clinical Network (EPPIC-Net). EPPIC-Net will serve as the cornerstone of the NIHs Helping to End Addiction Long-term (HEAL) Initiative. EPPIC-Net will provide a robust and readily accessible infrastructure for carrying out in depth phenotyping and biomarker studies in patients with specific pain conditions, and the rapid design and performance of high-quality Phase 2 clinical trials to test promising novel therapeutics for pain from partners in academia or industry. Studies will bring intense focus to patients with well-defined pain conditions and high unmet therapeutic needs. EPPIC-Net will consist of one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC) and approximately 10 specialized clinical centers (hubs). The purpose of this funding opportunity announcement (FOA) is to invite applications for the hubs within EPPIC-Net. A hub will typically be a regional medical center that will actively enroll subjects into clinical trials and studies performed in EPPIC-Net. Each hub should have ready access to patient populations with specific pain conditions and have expertise in characterization of that pain condition. A hub will additionally provide scientific leadership and administrative oversight to its multiple (2-10) satellite sites (spokes). This FOA solicits applications EPPIC-Net Specialized Clinical Centers. Separate FOAs have been issued to solicit applications for the Clinical Coordinating Center (RFA-NS-18-036) and Data Coordinating Center (RFA-NS-18-035). Clinical trials conducted through EPPIC-Net may come from a variety of sources including the HEAL Partnership, as described above, or from separate NIH funding announcements.

HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)

RFA
Monday, December 10, 2018
Tuesday, February 12, 2019
UG3/UH3
RFA-NS-19-021

Funding Opportunity Purpose

The Purpose of this FOA is to solicit cooperative agreement applications that propose clinical trials to establish the effectiveness of existing therapies and approaches for prevention and management of pain. The studies must address questions within the mission and research interests of participating NIH Institutes and Centers and evaluate preventive strategies or interventions including medications, biologics, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, rehabilitation strategies, complementary therapies, integrated approaches, and delivery system strategies in well controlled trials The overall goal is to inform clinicians about the effectiveness of interventions that will improve functional outcomes and reduce pain across the continuum of acute to chronic pain associated with many types of diseases or conditions or pain presenting as a disease itself. Clinical trials will be conducted within the infrastructure of the HEAL Pain Management Effectiveness Research Network.

HEAL Initiative: Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) (UG3/UH3, Clinical Trials Optional)

RFA
Monday, December 10, 2018
Saturday, February 9, 2019
UG3/UH3
RFA-AT-19-004

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages UG3/UH3 phased cooperative research applications to conduct efficient, large-scale pragmatic trial or implementation science study designs to improve pain management and reduce the use of opioid medications. Awards made under this FOA will initially support a one-year milestone-driven planning phase (UG3), with possible transition to an implementation phase (UH3). UG3 projects that have met the scientific milestone and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA. The overall goal of this initiative is to identify effective methods to improve the management of pain and reduce the need for opioid medications at the health care system level. This FOA requires that the intervention under study be embedded into health care delivery system, real world settings. Studies can propose to integrate interventions that have demonstrated efficacy into health care system; or implement health care system changes to improve adherence to evidence-based guidelines. Trials must be conducted across two or more health care systems (HCS) and must be conducted as part of the NIH HCS Research Collaboratory supported through the NIH Common Fund. (See https://commonfund.nih.gov/hcscollaboratory). The NIH HCS Research Collaboratory Program has established a Collaboratory Coordinating Center (CCC) that is providing national leadership and technical expertise in all aspects of research with HCS. After awards are made by NIH, the CCC (http://rethinkingclinicaltrials.org/about-nih-collaboratory/) and the NIH will work with successful awardees from this FOA to facilitate the planning and rapid execution of high impact trials that conduct research studies in partnerships with health care delivery systems.

HEAL Initiative: Stimulating Peripheral Activity to Relieve Conditions (SPARC): Anatomical and Functional Mapping of Pain-Related Visceral Organ Neural Circuitry (U01 Clinical Trial Optional)

RFA
Monday, December 10, 2018
Saturday, February 9, 2019
U01
RFA-RM-19-001

Funding Opportunity Purpose

The purpose of this NIH Funding Opportunity Announcement (FOA) is to invite research applications proposing to map neural circuitry mediating visceral organ pain. This FOA is part of the Stimulating Peripheral Activity to Relieve Conditions (SPARC) Common Fund program and is coordinated with the Translational Devices to Treat Pain (TDTP) initiatives of the NIH HEAL program (see Companion Funding Opportunities above). Detailed mapping of pain-mediating circuitry originating from visceral organ afferents will leverage the SPARC program to produce maps that could accelerate the development of non-addictive approaches to treat pain.

Immuno-Oncology Translation Network (IOTN): Cancer Immunoprevention Research Projects (U01 Clinical Trial Not Allowed)

RFA
Wednesday, October 31, 2018
Saturday, February 9, 2019
U01
RFA-CA-19-014

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) is associated with the Beau Biden Cancer MoonshotSM Initiative that is intended to accelerate cancer research. Specifically, this FOA targets the following area designated as scientific priority by the Blue Ribbon Panel (BRP): Recommendation B. Create a translational science network devoted exclusively to immunotherapy approaches to treat and prevent adult cancers. The goal of the network is to foster collaborative team science approaches to accelerate the discovery of new immune targets and evaluate novel immune-based therapies and combination approaches that eliminate established cancers in adults or to prevent cancers before they occur. The purpose of this specific FOA is to establish Cancer Immunoprevention Research Projects that will function as components of a Cancer Immunotherapy Consortium (CIC), which will also include Cancer Immunotherapy Research Projects. The CIC will form an integrated network of multi-disciplinary, collaborative teams with the overarching goals of accelerating translational research of innate and adaptive immune mechanisms that contribute to tumor initiation and progression, and evaluating new or improved immunopreventive and immunotherapeutic strategies (including combinations with standard or other therapies). Studies should be largely pre-clinical involving clinically-relevant models and endpoints, and have the potential for rapid translation into early-phase clinical applications.

Immuno-Oncology Translation Network (IOTN): Cancer Immunotherapy Research Projects (U01 Clinical Trial Not Allowed)

RFA
Wednesday, October 31, 2018
Saturday, February 9, 2019
U01
RFA-CA-19-015

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) is associated with the Beau Biden Cancer MoonshotSM Initiative that is intended to accelerate cancer research. The purpose of this FOA is to promote research to accelerate the discovery of new immune targets and evaluate novel immune-based therapies and combination approaches that eliminate established cancers in adults or to prevent cancers before they occur. Specifically, this FOA targets the following area designated as scientific priority by the Blue Ribbon Panel (BRP): Recommendation B. Create a translational science network devoted exclusively to immunotherapy approaches to treat and prevent adult cancers. The purpose of this FOA is to expand organ site-specific Cancer Immunotherapy Research Projects as components of the Immuno-Oncology Translation Network (IOTN). The IOTN will form an integrated network of multi-disciplinary, collaborative teams with the overarching goals of accelerating translational research of innate and adaptive immune mechanisms that contribute to tumor progression and evaluating new or improved immunotherapeutic strategies (including combinations with standard or other therapies) resulting in durable anti-cancer responses. Studies should be largely pre-clinical involving clinically-relevant models and endpoints.

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