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The Clinical Translational Research Award supports studies that will move promising, well-founded preclinical and/or clinical research findings closer to clinical application, including diagnosis, prognosis, or treatment of TSC. Projects supported by this award mechanism may include studies moving from preclinical to clinical research (including a pilot clinical trial) and/or the reverse, analyzing human anatomical substances and/or data associated with clinical trials (such as correlative studies). Studies advancing clinical trial readiness through development of biomarkers, clinical endpoints, and validation of PK/PD are of particular interest to the FY19 TSCRP. Preference will be given to studies that involve human samples, patients, or leverage existing clinical data and/or ongoing clinical studies. Preclinical studies may be appropriate but must include a clinical component. Projects that are exploratory and/or strictly animal research will not be considered for funding. Developmental pathways for translational research that may be useful for designing translational research studies for support under this mechanism can be found in the report of the National Cancer Institute Translational Research Working Group (http://clincancerres.aacrjournals.org/ content/14/18/5664.full). These pathways are comprehensive and span the entire translational research continuum from bench to bedside to bench.

The purpose of this funding opportunity announcement (FOA) is to invite applications for Clinical Centers (Hubs) in Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN).SIREN will enable conduct of high-quality, multi-site clinical trials to improve the outcomes for patients with neurologic, cardiac, respiratory, and hematologic, and trauma emergency events. SIREN will consist of one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC) and up to 10 clinical centers (Hubs). A Hub will typically be an academic center or tertiary referral center which will actively enroll patients into every clinical trial performed in SIREN, regardless of disease focus.A Hub will additionally provide scientific leadership and administrative oversight to its multiple satellite sites ("Spokes").Together the Hub and Spokes will provide access to a large and varying patient population for clinical trials. SIREN will implement a total of at least four large (1,000 patient) simple, pragmatic clinical trials in the emergency department and pre-hospital settings. The clinical trials will be meritorious, peerreviewed projects which will be awarded under separate funding announcements.

This Funding Opportunity Announcement (FOA) is limited to those Program Director(s)/Principal Investigator(s) of Rare Diseases Clinical Research Consortia (RDCRC) who received an NINDS award under the Rare Diseases Clinical Research Network (RDCRN) program through RFA-TR-13-002, or an NCI award through RFA-OD-08-001. The purpose of this limited competition FOA is to allow these NINDS- and NCI-awarded consortia an opportunity to compete for another four years of participation in the RDCRN. The RDCRN is a collaborative and coordinated network of Clinical Research Consortia comprised of investigators and patient advocacy groups committed to investigation of rare diseases working in partnership with a Data Management Coordinating Center (http://grants.nih.gov/grants/guide/rfa-files/RFA-TR-13-003.html) to enhance communication and sharing of resources in a multidisciplinary approach. This FOA intends to support: 1) collaborative clinical research in rare diseases, including longitudinal studies of individuals with rare diseases, clinical studies and/or clinical trials; 2) career development and advancement opportunities for clinical investigators in rare diseases research; 3) pilot/demonstration (proof of concept) clinical research projects; and 4) access to information related to rare diseases for basic and clinical researchers, physicians, patients, and the lay public.

The OPORP Orthotics and Prosthetics Outcomes Research Award (OPORA) is being offered for the first time in FY14. It is intended to support research that evaluates the comparative effectiveness of and functional outcomes associated with prosthetic and orthotic clinical interventions and/or other rehabilitation interventions for Service Members and Veterans who have undergone limb salvage or limb amputation. The goal is to improve our understanding of and ultimately advance the implementation of the most effective prescriptions for prosthetic and orthotic devices, treatment, rehabilitation, and secondary health effect prevention options for patients, clinicians, other caregivers, and policymakers. Proposed projects should be designed to provide outcomes data regarding orthotic and prosthetic devices, and/or related clinical interventions and must include the anticipated effect on patient care metrics. Collaboration with military researchers and clinicians is encouraged, as are joint Department of Defense (DoD)-VA studies, including longitudinal outcome studies. Studies are sought that: * Compare different patient care approaches. * Include patient-centric outcome assessments. * Have the potential to generate new knowledge that can be developed into new clinical practice guidelines, and/or new prescription algorithms for prosthetic and orthotic devices. * Have the potential to develop new technology for improved prosthetic and orthotic devices, therefore improving patient outcomes. * Provide information on quality of life, reintegration, and/or return to duty/return to work as it pertains to those patients who use a prosthetic or orthotic device due to limb trauma. All applications must demonstrate direct relevance to Service Members and Veterans with traumatic extremity injury and/or amputation using prosthetics and orthotic devices. Examples of studies that are appropriate for submission to the FY14 OPORA include, but are not limited to, examination of the

The purpose of the NIH Mentored Research Scientist Development Award (K01) is to provide support and protected time (three to five years) for an intensive, supervised career development experience in the biomedical, behavioral, or clinical sciences leading to research independence. Although all of the participating NIH Institutes and Centers (ICs) use this support mechanism to support career development experiences that lead to research independence, some ICs use the K01 award for individuals who propose to train in a new field or for individuals who have had a hiatus in their research career because of illness or pressing family circumstances. Other ICs offer separate K01 FOAs intended to increase research workforce diversity. 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 clinical trial. 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 clinical 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 (XXXX).

TTSA supports hypothesis-driven translational studies. These studies should be associated with an ongoing or completed clinical trial and/or annotated biorepositories and focused on research for the next-phase clinical trial or future clinical application. The TTSA is intended to support advanced translational studies that have the potential for near-term outcomes that are based on results from clinical investigations. While funding for clinical trials is allowed, the TTSA is intended to fund correlative clinical research studies and not only a clinical trial. Research projects funded by the TTSA should address critical knowledge gaps in clinical outcomes, validate key research results, expand upon potentially transformative results, or investigate novel findings based on results from clinical research.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue translational activities and clinical trials to treat pain with innovative, targeted, and non-addictive diagnostic and/or therapeutic devices that improve patient outcomes and decrease or eliminate the need to prescribe opioids. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, as well as a subsequent small clinical trial (e.g., Early Feasibility Study). The clinical trial is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in the development of the project plan and monitoring of research progress. This FOA will leverage Public-Private Partnership Programs (PPP) initiated under the NIH BRAIN Initiative, the Office of Strategic Coordination The Common Funds Stimulating Peripheral Activity to Relieve Conditions (SPARC) Program, and the HEAL Initiative. These programs include agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general, it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without the need for significant additional non-clinical data.

The purpose of the NHLBI Career Pathway to Independence in Blood Science Award for Physician Scientists (K99) is to increase and maintain a strong cohort of new and talented, NHLBI supported, independent investigators in blood science. This program is designed to facilitate a timely transition of outstanding blood science researchers with a clinical doctorate degree from mentored research positions to independent, tenure-track or equivalent faculty positions. This K99 award is intended for individuals who require at least three and up to five years of mentored research training and career development before transition to the R00 award. At the conclusion of the K99, awardees are expected to continue research activity with support from a separate NHLBI-funded FOA, the Physician Scientist Transition to Independence in Blood Science Research (R00 - Clinical Trial Optional), described in NOT-HL-18-657, which will require updated plans and a limited competition review. 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 clinical 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 the companion FOA (RFA-HL-20-001).

The purpose of this Funding Opportunity Announcement (FOA) is to promote innovative research on music and health with an emphasis on developing music interventions aimed at understanding their mechanisms of action and clinical applications with little or no preliminary data. Because of the need for a multidisciplinary approach, collaborations among basic researchers, translational science researchers, music intervention experts, other clinical researchers, music health professionals, and technology development researchers are encouraged. The FOA utilizes a phased R61/R33 funding mechanism to support mechanistic research and to evaluate the clinical relevance of music interventions. The R61 phase will provide funding to either investigate the biological mechanisms or behavioral processes underlying music interventions in relevant animal models, healthy human subjects, and/or clinical populations, or can be used to develop innovative technology or approaches to enhance music intervention research. The second R33 phase will provide support for further mechanistic investigations, intervention development, or pilot clinical studies. The pilot clinical studies may focus on intervention optimization/refinement, feasibility, adherence, and/or identification of appropriate outcome measures to inform future clinical research. Transition from the R61 to the R33 phase of the award will depend on successful completion of pre-specified milestones established in the R61.

The main goal of this limited competition Funding Opportunity Announcement (FOA) is to continue the state-of the-art biobanking infrastructure and operations for early-stage and experimental clinical trials sponsored by the National Cancer Institute (NCI). The biobanking needs of the following NCI clinical trial programs will be supported: Experimental Therapeutics Clinical Trials Network (ETCTN), and Other NCI-supported early and experimental trials. Currently, this biobanking infrastructure supporting NCI early experimental clinical trials is part of a biobank serving primarily another NCI program, National Clinical Trials Network (NCTN). Through a separate U24 award under this FOA, the NCI aims to separate the existing ETCTN-serving biobanking infrastructure and operation from the current NCTN Biobank. This separated entity will be termed: Early-Phase and Experimental Clinical Trials Biospecimen Bank (also referred to as EET Biobank). Although the EET Biobank and the "parent" NCTN Biobank may be hosted in the same institution, they are expected to become independent operations with separate leaderships. EET Biobank will be responsible for collecting, processing, storing a variety of human specimens from patients with cancer who are participating in NCI-funded ETCTN and other NCI-supported early and experimental clinical trials. The responsibilities of EET Bank will also include maintenance of up-to-date specimen inventory and specimen distribution to qualified NCI-approved trial investigators and research laboratories.

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.

The purpose of the NIH Mentored Patient-Oriented Research Career Development Award (K23) is to support the career development of individuals with a clinical doctoral degree who have made a commitment to focus their research endeavors on patient-oriented research. 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 a separate ancillary 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 clinical trial as lead investigator, should apply to the companion FOA (xxxxxx

This Funding Opportunity Announcement (FOA) invites applications to enhance the pool of of highly trained investigators from diverse backgrounds underrepresented in research. It is targeted toward individuals whose basic, clinical, and translational research interests are grounded in the advanced methods and experimental approaches needed to solve problems related to cardiovascular, pulmonary, and hematologic diseases and sleep disorders in the general and health disparities populations. This FOA invites applications from Institutions with eligible faculty members to undertake special study and supervised research under a mentor who is an accomplished investigator in the research area proposed and has experience in developing independent investigators. This 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 (see RFA-HL-19-025).

This purpose of this Funding Opportunity Announcement (FOA) is to provide a mechanism of support to research organizations interested in clinically translating already optimized quantitative imaging software tools capable of measuring or predicting the response of cancer to clinical therapies, or in translating imaging software tools for planning and validating radiation therapy treatment strategies in clinical trials. The quantitative software tools must have been developed and optimized during a performance period in the Quantitative Imaging Network (QIN) or under other separate funding. The proposed research effort should be an extension of the research that successfully completed the tasks of developing and optimizing the chosen software tools or data collection methods intended to facilitate clinical decision making during clinical trials. This FOA is intended to support the efforts of validating those software tools in prospective multisite clinical trials to test software tool performance and to demonstrate that the software tool can be integrated into clinical workflow with a minimum of disruption.

The ARP Clinical Translational Research Award is intended to support early-phase, proof-of-principle translational studies that will examine hypothesis-based, innovative interventions that have the potential to address current clinical deficits for ASD. Applications are strongly encouraged to address one of the ARP Clinical Translational Research Award Areas of Interest. If the proposed project does not address any of the FY19 ARP Clinical Translational Research Award Areas of Interest, the application should describe how the project will nevertheless address a critical need of the ASD community. Outcomes from studies funded by this award are anticipated to provide scientific rationale for subsequent development of larger, efficacy-based clinical trials of interventions that will transform ASD clinical care. Projects are required to involve human subjects. Projects that are strictly animal research aimed at developing or refining new technology and research to establish the efficacy/ effectiveness of diagnostic agents are not allowed under this funding opportunity. The proposed studies should include early-phase, proof-of-principle studies using human subjects. The proposed studies may be interventional, including Phase 0 clinical trials or single-group intervention studies, and may involve some retrospective data analysis; however, purely retrospective or database-related research is not allowed.

This NINDS K22 is specifically designed to facilitate the transition of NINDS intramural neurologist- and neurosurgeon-scientists to independent, academic faculty positions that support clinician-scientists to engage in independently funded scientific research as well as clinical activities. 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 (PAR-18-710).

The 2017 CDC STD Surveillance Report documented continued steep and sustained increases in the three reportable STDs - gonorrhea, chlamydia and syphilis. Congenital syphilis rates reached a 20-year high in 2017. Healthcare providers and health systems remain at the forefront of the battle against STDs. Provider education, technical assistance, and clinical capacity building are critical pieces for a foundation of comprehensive STD clinical prevention in healthcare settings. A dynamic and complex healthcare landscape demands innovative methods to reach both clinicians and healthcare settings from a variety of sectors throughout the U.S in order to meet the goal of optimal STD clinical prevention implementation in the clinical care setting. The purpose of this NOFO is to support The National Network of Sexually Transmitted Diseases Clinical Prevention Training Centers (NNPTC). This network is charged with improving the capacity of healthcare professionals, clinical sites and healthcare systems to employ state-of-the-art knowledge to diagnose, manage, treat and counsel individuals with and at-risk for STDs in order to reduce STD morbidity and improve sexual health on an individual, local and national level. This NOFO supports the following broad strategies : Component A Regional Centers: A1 (Core) - assess training needs and service gaps to inform the development and delivery of comprehensive STD clinical prevention T/TA for providers serving priority populations; A2 (Focus Activity) - pr

The purpose of the NIH Pathway to Independence Award (K99/R00) program is to increase and maintain a strong cohort of new and talented, NIH-supported, independent investigators. 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 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 (PA-18-397).

The Investigator-Initiated Translational Research Award (IITRA) supports translational research that will develop promising ideas in lung cancer into clinical applications. Translational research may be defined as an integration of basic science and clinical observations. Observations that drive a research idea may originate from a laboratory discovery, population-based studies, or a clinician's firsthand knowledge of patient care. The ultimate goal of translational research is to move a concept or observation forward into clinical application. However, Principal Investigators (PIs) should not view translational research as a one-way continuum from bench to bedside. The research plan must involve a reciprocal flow of ideas and information between basic and clinical science. This mechanism is intended to fund a broad range of translational studies, including, but not limited to, the following: * Studies advancing/translating in vitro and/or animal studies to applications with human samples/cohorts. * Late-stage preclinical work leading to/preparing for a clinical trial, e.g., Investigational New Drug (IND) application submission. * Correlative studies that are associated with an ongoing or completed clinical trial and projects that develop endpoints for clinical trials. Preliminary data to support the feasibility of the research hypotheses and research approaches are required; however, these data do not necessarily need to be derived from studies of lung cancer.

Applications addressing one of the SVS Clinical Research Priorities are particularly encouraged. Small-scale clinical trials and ancillary studies in the setting of existing clinical trials (industry or NIH-supported) will be accepted. Relevant examples include:  · Ancillary studies coupled to existing clinical trials. A letter of support from the primary trial sponsor is required. · Pilot clinical trials of any type · Studies on the natural history of vascular disease, pathophysiology, or mechanisms underlying success or failure of vascular interventions · Application of quality-of-life, functional status, and resource utilization measures to assess the impact of vascular interventions · Development and validation of clinical risk-prediction models or diagnostic tools · Studies addressing the nature of disparities in care and outcomes