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This Funding Opportunity Announcement (FOA) invites applications for an Early Psychosis Intervention Network (EPINET) National Data Coordinating Center (ENDCC) to support and extend the work of regional scientific hubs described in companion announcement RFA-MH-19-150. The ENDCC will lead efforts to (a) harmonize early psychosis common data elements, standard measures, and uniform data collection procedures across multiple early psychosis Coordinated Specialty Care (CSC) clinics within regional networks; (b) build informatics infrastructure and pipelines necessary to gather and store de-identified, patient-level data collected across all regional clinics; (c) develop data analysis, presentation, and reporting tools to facilitate timely quality improvement and program evaluation efforts across regional networks; (d) identify innovative CSC assessment, intervention, and quality improvement practices for broad dissemination; and (e) make national CSC data available for practice-based research to improve early identification, diagnosis, clinical assessment, intervention effectiveness, service delivery and health outcomes in early psychosis. The ENDCC will combine regional datasets into a national repository of early psychosis common data elements, clinical measures, assessment and intervention strategies, and de-identified person-level data from patients receiving CSC services. Data assembled by the ENDCC will facilitate large-scale, practice-based research to improve early identification, diagnosis, clinical assessment, intervention effectiveness, and health outcomes in clinics offering evidence-based care to persons in the early stages of psychotic illness.

The purpose of this Funding Opportunity Announcement (FOA) is to invite Cooperative Agreement applications to develop research resources that will encourage a consensus on how Quantitative Imaging (QI) methods are optimized to improve the quality of imaging results for co-clinical trials. The scientific goals of this FOA are to: (a) perform the appropriate optimization of the pre-clinical quantitative imaging methods, (b) implement the optimized methods in the co-clinical trial, and finally (c) populate a web-accessible research resource with all the data, methods, workflow documentation, and results collected from the co-clinical investigations. Co-clinical trials are defined in this FOA as investigations in patients and in parallel (or sequentially) in mouse or human-in-mouse models of cancer that mirror the genetics and biology of the patients malignancies or pre-cancerous lesions. The co-clinical trial should include either (a) a therapeutic goal, such as the prediction, staging, and/or measurement of tumor response to therapies, or (b) a screening and early detection or a cancer risk stratification goal for lethal cancer versus non-lethal disease. Applicants are encouraged to organize multi-disciplinary teams with experience in mouse models research, human investigations, imaging platforms, QI methods, decision support software and informatics to populate the research resource.

A rare disease is defined by the Orphan Drug Act as a disease that affects less than 200,000 people in the US. As described in FDA draft Guidance, "Rare Diseases: Common Issues in Drug Development Guidance for Industry" (https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm458485.pdf ), fit-for-purpose clinical endpoints for many rare diseases are not available. Selection or development of clinical outcome assessments for use to support efficacy of a treatment in a rare disease can be challenging due to the small sample size of possible participants for participation in instrument development and clinical trials and heterogeneity of the target patient population (e.g., phenotypic or genotypic variations, age, clinical manifestations, variations in patient experience, and rate of disease progression). However, many rare diseases share similar clinical characteristics such as decline in cognition and physical function, which offers an opportunity to explore clinical outcome assessments that may cover a spectrum of rare diseases.

The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA), seeks highly meritorious clinical trial applications proposing to explore and enable the development of safe and effective regenerative medicine (RM) interventions using adult stem cells. This Funding Opportunity Announcement (FOA), issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a statutory provision set forth in the 21st Century Cures Act. Applications submitted in response to this bi-phasic, milestone-driven cooperative agreement FOA are expected to propose highly innovative projects with a focus on solutions to widely-recognized issues in the development of safe and effective RM therapies. Of particular interest are projects using RM products that have undergone appropriate product development and pre-clinical studies and have demonstrated readiness to advance into clinical trials. This FOA seeks Phase I and beyond clinical trial applications that present a strong scientific rationale for the proposed clinical trial and a comprehensive scientific and operational plan. Trials must be relevant to the research mission of one or more participating NIH Institutes and Centers and meet the NIH definition of a clinical trial (see NOT-OD-15-015). Applications are expected to include plans for project management, participant recruitment and retention, performance milestones, conduct of the trial, and dissemination of results. Before the time of award and if applicable, successful applicants must obtain an Investigational New Drug (IND) authorization or Investigational New Device Exemption (IDE) approval to administer the product to humans.

This Funding Opportunity Announcement (FOA) is to support Exploratory/Developmental Research Grants (R21) that propose small scale or pilot and feasibility clinical and translational research studies, including epidemiological studies or clinical trials related to kidney disease research. Studies should address important clinical and translational questions and are potentially of high clinical and public health impact. It is anticipated that some projects supported by these grants may lead to full-scale clinical studies including diagnostic strategies, epidemiological studies, or randomized clinical trials of diagnosis, prevention, or treatment of kidney diseases.

This FOA encourages applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing a future trial, for biomarker validation studies, or for proof of mechanism clinical studies. Diseases chosen for study should be based on the NINDS' strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm). Successful applicants will be given access to the NeuroNEXT infrastructure. Following peer review, NINDS will prioritize and order trials that are given access to the NeuroNEXT infrastructure. The NeuroNEXT clinical Coordinating Center (CCC) will work with the successful applicant to efficiently implement the proposed study. The NeuroNEXT Data Coordinating Center (DCC) will provide statistical and data management support. The NeuroNEXT clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol.

This program will address the clinical research mission of the National Institutes of Health (NIH) and will lead to better treatments for disease and to improvements in human health.  The NIH funds research and research training at extramural institutions, as well as within the NIH Intramural Research Program (IRP) to address this goal.  However, these efforts can be hindered by barriers to clinical and translational research.  Such barriers include limited research time for clinical investigators, increases in the length of time to independent careers, and access to hospital facilities and patient enrollments. In an effort to address those barriers, the NIH has created the Lasker clinical Research Scholars (Lasker Scholars) program that will offer applicants the opportunity to compete for a unique combination of intramural and extramural resources for clinical research. The program will support a small number of exceptional clinical researchers in the early stages of their careers to promote their development to fully independent scientists.  The program combines a period of research experience as a tenure-track Investigator in the IRP with additional years of independent financial support, either within the IRP or at an extramural research institution. The Scholar must meet the conditions described below, including fulfilling milestones and agreement with IRP, in order to receive the additional years of funding.

This Funding Opportunity Announcement (FOA) will support extramural research to investigate and mitigate challenges facing clinical assay development due to biopsy biospecimen preanalytical variability. The program will tie in with current efforts to optimize clinical biomarker assays utilized in NCI-sponsored clinical trials. Results from this research program will improve the understanding of how biopsy collection, processing, and storage procedures may affect all aspects of analytical performance for current and emerging clinical biomarkers, as well as expedite clinical biomarker assay development through the evidence-based standardization of biopsy handling practices. Critical information gained through these research awards may increase the reliability of clinical biomarker assays, reduce time requirements for assay development, and decrease assay failure during late-stage testing.

The purpose of the NHLBI Career Pathway to Independence in Blood Science Award for Physician Scientists (K99) is to increase and maintain a stong 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. Applicants who receive this award may submit an application for R00 funding, in the separate funding opportunity associated with this program, to help awardees to launch competitive, independent research careers in blood science. 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 (RFA-HL-20-001).

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 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).

The FY18 PH/TBIRP CTRR-CTDA mechanism is being offered for the first time in FY18 and is intended to support the development of clinical trials focused on TBI rehabilitation interventions in the FY18 PH/TBIRP CTRR-CTDA focus areas described in II.A.1. Development of clinical trials focusing on rehabilitation strategies in patients with mild TBI is highly encouraged. The proposed research must be relevant to active duty Service members, Veterans, and their beneficiaries. It is expected that any research findings will also provide benefit to the general population. The PH/TBIRP CTRR-CTDA mechanism supports the design and development of the research resources necessary to serve as a foundation for investigator-initiated clinical trials under future PH/TBIRP CTRR-clinical Trial Award with the potential to develop knowledge and material products for rehabilitation and restoration of function following TBI. Principal Investigators (PIs) should explain how the proposed future clinical trial will inform the development, refinement, and/or revision of existing standards of care, clinical recommendations, or guidelines.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage institutions to propose creative and innovative institutional research career development programs which prepare clinically-trained vision scientists for independent research careers. This initiative is intended to expand and strengthen the community of investigators engaged in clinical research. Such an increase in the number of well-trained clinical researchers is necessary to achieve a pool of scientists with contemporary, multidisciplinary expertise able to leverage recent advances in ocular genetics, therapeutics, bioengineering, and bio-behavioral research in order to enhance patient treatment and to increase scientific momentum in these fields. This Funding Opportunity Announcement (FOA) allows appointment of Scholars (K12) proposing a separate ancillary study to an existing trial or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development. Applications supported by this FOA that meet the NIH definition of a clinical trial (see NOT-OD-15-015) must also fulfill the NIH requirements for either a mechanistic or minimal risk trial. A mechanistic trial is designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. A minimal risk trial is one in which the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. A proposed research career development program that includes a clinical trial that is not a mechanistic trial and/or involves a level of risk beyond that defined as minimal, will not be supported.

The Mentored Career Transition Award for NIMH Intramural Fellows (K22) is a two-phase, mentored career development award program that is intended to facilitate a timely transition of qualified postdoctoral fellows in the NIMH Division of Intramural Programs (DIRP) from intramural postdoctoral research positions to extramural, academic tenure-track or equivalent faculty positions at eligible U.S. institutions. Both the intramural and extramural phases will be mentored, and the award will provide research support during the extramural phase to help awardees launch competitive, independent research programs. 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-18-613).

The purpose of the Mentored Quantitative Research Career Development Award (K25) is to attract to NIH-relevant research those investigators whose quantitative science and engineering research has thus far not been focused primarily on questions of health and disease. The K25 award will provide support and "protected time" for a period of supervised study and research for productive professionals with quantitative (e.g., mathematics, statistics, economics, computer science, imaging science, informatics, physics, chemistry) and engineering backgrounds to integrate their expertise with NIH-relevant 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 an 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 ().

The 2016 U.S. Advancing Science through Pfizer: Investigator Research Exchange (ASPIRE) Hemophilia Research Awards Program is a competitive grants program that reflects the commitment of Pfizer Hemophilia to support ongoing basic science and clinical investigation in hemophilia A and B. Ongoing basic science research and clinical research are critical to deepen understanding of disease mechanisms and to ensure advancement of management strategies for hemophilia A and hemophilia B and their related comorbidities. In an era of increased competition for research funding, the 2016 U.S. ASPIRE Hemophilia Research Awards Program is designed to support laboratory and clinical research in pathogenesis, complications, management, and clinical outcomes of hemophilia A and B.

The 2016 U.S. Advancing Science through Pfizer: Investigator Research Exchange (ASPIRE) Hemophilia Research Awards Program is a competitive grants program that reflects the commitment of Pfizer Hemophilia to support ongoing basic science and clinical investigation in hemophilia A and B. Ongoing basic science research and clinical research are critical to deepen understanding of disease mechanisms and to ensure advancement of management strategies for hemophilia A and hemophilia B and their related comorbidities. In an era of increased competition for research funding, the 2016 U.S. ASPIRE Hemophilia Research Awards Program is designed to support laboratory and clinical research in pathogenesis, complications, management, and clinical outcomes of hemophilia A and B.

This Funding Opportunity Announcement (FOA) announces the availability of a one-time administrative supplement for clinical research awards from limited NIH Institutes and Centers and for specific types of awards, listed above in 'Activity Codes', to support research on sleep disturbance and chronic pain. The proposed activities may include the addition of: sleep assessment to clinical studies of pain; pain assessment to clinical studies of sleep; measures of sleep and/or pain for clinical studies already incorporating sleep and/or pain measures; additional data collection time points for clinical studies already incorporating sleep and/or pain measures; or secondary data analysis of clinical studies to explore contributions of sleep disturbances to chronic pain as long as the research objectives are within the original scope of the peer reviewed and approved project and can be completed within the remaining funding period. The final goal of the supplement should be a contribution to methods or understanding needed for future larger scale studies that directly investigate the interactions between sleep disturbances and chronic pain.

This Funding Opportunity Announcement (FOA) invites researchers to submit applications for support of clinical projects that address critical needs for clinical trial readiness in rare diseases. The initiative seeks applications that are intended to facilitate rare disease research by enabling efficient and effective movement of candidate therapeutics or diagnostics towards clinical trials, and to increase their likelihood of success through development and testing of rigorous biomarkers and clinical outcome assessment measures, or by defining the presentation and course of a rare disease to enable the design of upcoming clinical trials.

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 purpose of this FOA is to identify and support a Clinical Coordination Center (CCC) for the Common Fund Acute to Chronic Pain Signatures (A2CPS) Program. The Clinical Coordinating Center is expected to serve as the hub for the Multisite Clinical Centers (below) to support study design, efficiency, progress, and quality, and to coordinate and monitor study implementation across the Clinical sites. The Clinical Coordinating Center will lead the consortium in developing and implementing standardized protocols, safety standards, staff training protocols, electronic health record (EHR) data standards, patient phenotyping and testing, and regulatory processes.

This Funding Opportunity Announcement (FOA) will support students at institutions without NIH-funded institutional predoctoral dual-degree training programs. The purpose of the Kirschstein-NRSA, dual-doctoral degree, predoctoral fellowship (F30) is to enhance the integrated research and clinical training of promising predoctoral students, who are matriculated in a combined MD/PhD or other dual-doctoral degree training program (e.g., DO/PhD, DDS/PhD, AuD/PhD, DVM/PhD), and who intend careers as physician/clinician-scientists. Applicants must propose an integrated research and clinical training plan and a dissertation research project in scientific health-related fields relevant to the missions of the participating NIH Institutes and Centers. The fellowship experience is expected to clearly enhance the individual's potential to develop into a productive, independent physician/clinician-scientist. This Funding Opportunity Announcement (FOA) does not allow applicants to propose to lead an independent clinical trial, clinical trial feasibility study, or an ancillary clinical trial, but does allow applicants to propose research experience in a clinical trial led by a sponsor or co-sponsor.