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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 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).

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 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.

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.

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).

This Funding Opportunity Announcement (FOA) is to support studies that are essential, yet also sufficient, for investigators to make definitive decisions about the designs of important clinical trials within NHLBI's mission, the prevention and treatment of heart, lung, blood, and sleep disorders. This mechanism may be used to test the feasibility of novel and efficient (pragmatic) trial designs, as well as determine the feasibility of an intervention, intervention parameters, subject availability, or other information essential to complete the design of a trial. Applications should demonstrate that the proposed pilot studies are both necessary and sufficient to permit definitive decisions about the design of the subsequent clinical trial. Applicants who propose solely to write a protocol or manual of operations or to develop infrastructure for a clinical trial will not be considered appropriate for this announcement. The NHLBI anticipates that the R34 award period will yield robust investigator-initiated clinical trial grant applications for the evaluation of interventions for the treatment or prevention of heart, lung, blood, or sleep disorders.

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 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 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 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).

Supported by the NIH Common Fund (Common Fund) Science of Behavior Change (SOBC) Program, this Funding Opportunity Announcement (FOA) solicits competitive revision (formerly known as a competitive supplement) applications to NIH-supported clinical trials awarded as research project R34 grants. The goal of the SOBC Program is to advance a mechanisms-focused, experimental medicine approach to behavior change research. Funded projects in the SOBC Research Network (https://commonfund.nih.gov/behaviorchange/fundedresearch) have developed experimental manipulations, assays, and/or measures (hereafter referred to as assays for brevity) to support an experimental medicine approach to behavior change research. The SOBC Measures Repository is accessible from the SOBC Research Network Open Science Framework (OSF) page at https://osf.io/zp7b4. The goal of this FOA is to accelerate the adaptation, validation, and translation of SOBC Research Network assays for use in ongoing clinical trials. This FOA calls for the integration of SOBC Research Network assays into active NIH-supported clinical trials of drugs, devices, procedures, or behavior modifications. As such, the active NIH-supported clinical trial used to respond to this FOA does not have to be a behavior change trial or identify behavior change as a primary outcome. The integration of SOBC Research Network assays into ongoing clinical trials will accelerate the development of interventions and experimental manipulations that have been shown to engage specific mechanisms of behavior change and the development of assays that verify engagement of those behavior change targets.

This Funding Opportunity Announcement (FOA) solicits renewal applications for Biobanks that will support the following NCI clinical trial programs: The NCI National Clinical Trials Network (NCTN; https://research.usc.edu/nci-national-clinical-trials-network-nctn-program/), and NCI Community Oncology Research Program (NCORP). The NCTN Biospecimen Bank (also referred to as NCTN Biobanks) will be responsible for collecting, processing, storing, and distributing well-annotated human specimens from patients with cancer who are participating in NCI-funded NCTN Phase II-III and other clinical treatment trials (CTEP/Division of Cancer Treatment and Diagnosis; DCTD). The main goal is to support NCTN with the state-of the-art banking infrastructure and operations including maintenance of up-to-date specimen inventory. The NCTN Biobanks will distribute to qualified investigators the biospecimens linked to high-quality clinical data (including treatment and outcome information) that are critical for developing and validating biomarkers for cancer diagnosis, prognosis and prediction of responses to therapy. The NCTN Biobanks will work in collaboration with NCTN Groups and Group Statistical and Data Management Centers as well as affiliated institutions to ensure effective operation. Each Biobank needs to maintain association with one specific NCTN Group and needs to be endorsed in that role by the group leaders. NCTN Biobanks will also support biobanking and storage of biospecimens from NCORP cancer control and prevention trials (NCORP/Division of Cancer Prevention; DCP).

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 SCIRP CTA supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of SCI. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. Proposed projects may range from small proof-of-concept trials (e.g., pilot, first in human, Phase 0), to demonstrate feasibility or inform the design of more advanced trials, through large-scale trials to determine efficacy in relevant patient populations.

The goal of this funding opportunity announcement (FOA) is to support pilot testing of natural products (i.e., botanicals, dietary supplements, and probiotics), which have a strong scientific premise to justify further clinical testing. Under this FOA, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support decisions about further development or testing of the natural product. This FOA is not intended to support a randomized controlled trial (RCT) to test the efficacy of the natural product on clinical outcomes.  Rather, the data collected should be used to fill gaps in scientific knowledge and provide the information necessary to develop a competitive full-scale clinical trial.

The goal of this funding opportunity announcement (FOA) is to support pilot testing of natural products (i.e., botanicals, dietary supplements, and probiotics), which have a strong scientific premise to justify further clinical testing. Under this FOA, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support decisions about further development or testing of the natural product. This FOA is not intended to support a randomized controlled trial (RCT) to test the efficacy of the natural product on clinical outcomes.  Rather, the data collected should be used to fill gaps in scientific knowledge and provide the information necessary to develop a competitive full-scale clinical trial.