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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.

(RFA-NS-19-025 is being reissued to accommodate an additional receipt date). 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.

This funding opportunity aims to stimulate multi-disciplinary collaboration and secondary analyses of existing clinical research datasets, from two or more multi-site clinical research studies, for addressing scientific and / or clinically relevant hypotheses that have the potential to address knowledge gaps to inform future clinical trials and/or improve clinical care in research areas within the NINDS mission. For purposes of this RFA, "existing clinical research datasets" refers to datasets from clinical trials, natural history studies, and / or comparative effectiveness research studies but excludes "mechanistic clinical studies" and "basic experimental studies of humans" (for definitions see https://grants.nih.gov/grants/guide/notice-files/NOT-NS-18-011.html and https://grants.nih.gov/grants/glossary.htm#BasicExperimentalStudieswithHumans, respectively). This RFA will support the curation and analyses of datasets from two or more multi-site clinical research studies to conduct additional secondary analyses; it will not support the collection of new data.

This FOA relates to one of the initiatives of the SPARC (Stimulating Peripheral Activity to Relieve Conditions) Common Fund program titled: Use of Existing Market-Approved Technology for New Market Indications. By establishing effective public-private partnerships, this SPARC initiative allows supported investigators to have access to existing neuromodulation technology to explore new indications. A number of device manufacturers have entered into partnership agreements with the NIH to make their neuromodulation technology, consisting of implantable devices with recording and/or stimulation capabilities, available to SPARC's supported clinical investigators (see Device Portal for a list of companies and available technologies). The specific goal of this FOA is to promote the pre-clinical development of these technologies, in support of a new market indication, towards enabling an Investigational Device Exemption (IDE) submission for a future pilot clinical study. Awarded projects of this FOA that fully reach their pre-clinical testing milestones will be eligible for further support, subject to a subsequent FOA, to conduct a pilot clinical study. The expectation is that these pilot clinical studies will provide the initial proof-of-principle demonstrations in humans that will motivate the additional studies needed in pursuing FDA approval as a labeled indication.

This FOA relates to one of the initiatives of the SPARC (Stimulating Peripheral Activity to Relieve Conditions) Common Fund program titled: Use of Existing Market-Approved Technology for New Market Indications. By establishing effective public-private partnerships, this SPARC initiative allows supported investigators to have access to existing neuromodulation technology to explore new indications. A number of device manufacturers have entered into partnership agreements with the NIH to make their neuromodulation technology, consisting of implantable devices with recording and/or stimulation capabilities, available to SPARC's supported clinical investigators (see Device Portal for a list of companies and available technologies). The specific goal of this FOA is to promote the pre-clinical development of these technologies, in support of a new market indication, towards enabling an Investigational Device Exemption (IDE) submission for a future pilot clinical study. Awarded projects of this FOA that fully reach their pre-clinical testing milestones will be eligible for further support, subject to a subsequent FOA, to conduct a pilot clinical study. The expectation is that these pilot clinical studies will provide the initial proof-of-principle demonstrations in humans that will motivate the additional studies needed in pursuing FDA approval as a labeled indication.

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 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 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).

Announcement supports applied and translational research to advance the development of knowledge and materiel products for rehabilitation and restoration of function following TBI. PIs should explain how their work will inform the development, refinement, and/or revision of existing standards of care, clinical recommendations, or guidelines. TBI is defined as being caused by (1) a direct blow or impact to the head, (2) a penetrating head injury, or (3) an exposure to external forces such as blast waves that disrupt the function of the brain. Not all blows to the head or exposure to external forces result in a TBI. The severity of TBI may range from "mild," a brief change in mental status or consciousness, to "severe," an extended period of unconsciousness or confusion after the injury. Definitions of TBI severity can be found in Table 1 of the VA/DoD Clinical Practice Guideline for the Management of Concussion-Mild Traumatic Brain Injury. The FY17/18 PH/TBIRP CTRR-CRA supports clinical research but not clinical trials. Supported research can include observational research studies. The Clinical Research Award (CTRR-CRA) is intended to support clinical research focused on understanding the clinical sequelae and mechanisms of recovery associated with TBI and TBI rehabilitation interventions. The overarching goals of this award are to address TBI-related impairments and deficits including sensory, sensorimotor, and cognitive dysfunction to (1) develop and validate rehabilitation outcome measures; (2) define and evaluate mechanisms of injury progression or recovery associated with rehabilitation interventions; and (3) improve clinician-driven assessment strategies to guide return-to-duty decision making.

This Funding Opportunity Announcement (FOA) invites researchers to submit applications for support of clinical studies that address critical needs for clinical trial readiness in rare neurological and neuromuscular diseases. These studies should result in clinically validated biomarkers and clinical outcome assessment measures appropriate for use in upcoming clinical trials. Through the support of trial readiness studies, NINDS and NCATS expect to enhance the quality and increase the likelihood of success of clinical trials in these rare 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.

TBI is defined as being caused by (1) a direct blow or impact to the head, (2) a penetrating head injury, or (3) an exposure to external forces such as blast waves that disrupt the function of the brain. Not all blows to the head or exposure to external forces result in a TBI. The severity of TBI may range from "mild," a brief change in mental status or consciousness, to "severe," an extended period of unconsciousness or confusion after the injury. Definitions of TBI severity can be found in Table 1 of the VA/DoD Clinical Practice Guideline for the Management of Concussion-Mild Traumatic Brain Injury. The FY17/18 PH/TBIRP CTRR-CRA supports clinical research but not clinical trials. Supported research can include observational research studies. The FY17/18 PH/TBIRP Complex TBI Rehabilitation Research - Clinical Research Award (CTRR-CRA) is intended to support clinical research focused on understanding the clinical sequelae and mechanisms of recovery associated with TBI and TBI rehabilitation interventions.

The Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship for Students at Institutions Without NIH-Funded Institutional Predoctoral Dual-Degree Training Programs (Parent F30) award will support students at institutions without formal NIH-funded institutional predoctoral dual-degree training programs. The purpose of this FOA 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 individuals' potential to develop into a productive, independent physician/clinician-scientist. 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, but does allow applicants to propose research experience in a clinical trial led by a sponsor or co-sponsor.

This Funding Opportunity Announcement (FOA) is to promote the development and initial clinical validation of objective biological measures to be used for prognosing, and monitoring recovery of adolescents who either clinically present with or are at risk for developing prolonged/persistent concussive symptoms following exposure to repetitive head impacts and/or concussion.  Resultant biological measures should be incorporated into risk stratification algorithms to inform clinical care and patient stratification for future clinical trials.  A critical feature of this FOA includes the broad sharing of clinical, neuroimaging, physiological, and biospecimen data to further advance research in the area of persistent concussive symptoms in early and middle adolescent (EMA; ages 11-17 years old) populations.

The purpose of this funding opportunity announcement (FOA) is to support clinical studies that will fill gaps in the design of upcoming clinical trials in rare neurological or neuromuscular diseases by validating clinical outcome measures or biomarkers, or by characterizing cohorts of relevant patients.Through the support of trial readiness studies, NINDS expects to accelerate the initiation of clinical trials for rare diseases and to increase the likelihood of success in those trials.

The National Institute of Neurological Disorders and Stroke (NINDS) and National Institute on Aging (NIA) intend to publish a Funding Opportunity Announcement (FOA) to solicit applications for a large prospective clinical research study to determine the specific subsets of stroke events that predict cognitive impairment and dementia in post-stroke populations in the United States, including in health disparities populations, and what additional clinical factors and comorbidities along the AD/ADRD spectrum may causally synergize with stroke to result in (or prevent) cognitive impairment and dementia outcomes. The goals of this initiative are to determine the association between specific subsets of stroke events and subsequent cognitive impairment and dementia in post-stroke populations in the United States, including in health disparities populations; to identify additional clinical factors and comorbidities that may affect these associations; and to contribute to development and validation of clinical-trial ready diagnostic and progression biomarkers for post-stroke dementia. It is expected that the study design will also allow for determination of interrelationships (cross-sectional and longitudinal) among the stroke event, overall cerebrovascular and cardiovascular disease and risk factors (including sex, racial, and ethnic differences), dementia-relevant genetic variants (including ApoE) and mutations (e.g. in Notch 3) previously associated with Alzheimer's disease (e.g. APP, PS1, PS2, PICALM, CLU, TREM2), cognitive trajectories including decline and resistance to decline, as well as amyloid and tau biomarkers of Alzheimers pathology during life.

This Funding Opportunity Announcement (FOA) is aimed at discovering, characterizing the selectivity and sensitivity, and externally validating biological measures to be used for assessing, prognosing, and monitoring recovery of adolescents who either clinically present with or are at risk for developing prolonged/persistent concussive symptoms following exposure to repetitive head impacts and/or concussion. Resultant biological measures should be incorporated into risk stratification algorithms to inform clinical care and patient stratification for future clinical trials. A critical feature of this FOA includes the broad sharing of clinical, neuroimaging, physiological, and biospecimen data to further advance research in the area of persistent concussive symptoms in early and middle adolescent (EMA; ages 11-17 years old) populations.

Reissue of PAR-18-541. The Blueprint Neurotherapeutics Network (BPN) encourages applications from small businesses seeking support to advance their small molecule drug discovery and development projects into the clinic. Participants in the BPN are responsible for conducting all studies that involve disease- or target-specific assays, models, and other research tools and receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants and can augment their project with NIH contract research organizations (CROs) that specialize in medicinal chemistry, pharmacokinetics, toxicology, formulations development, chemical synthesis including under Good Manufacturing Practices (GMP), and Phase I clinical testing. Projects can enter either at the Discovery stage, to optimize promising hit compounds through medicinal chemistry to the Development stage, to advance a single development candidate through Investigational New Drug (IND)-enabling toxicology studies and phase I clinical testing. Alternatively, projects can enter at the Development stage and progress in a shorter period to IND enabling toxicology studies and phase I clinical testing. Projects that enter at the Discovery stage and meet their milestones may continue on through Development. BPN awardee institutions retain their assignment of IP rights and gain assignment of IP rights from the BPN contractors (and thereby control the patent prosecution and licensing negotiations) for drug candidates developed in this program.

The purpose of this funding opportunity announcement (FOA) is to support clinical studies that will fill gaps in the design of upcoming clinical trials in rare neurological or neuromuscular diseases by validating clinical outcome measures or biomarkers, or by characterizing cohorts of relevant patients. Through the support of trial readiness studies, NINDS expects to accelerate the initiation of clinical trials for rare diseases and to increase the likelihood of success in those trials.

The National Institutes of Health (NIH) invites applications for institutional research capacity building programs from entities/institutions in Institutional Development Award (IDeA)-eligible States that propose to support a team of experts to engage and implement pediatric clinical trials. The program aims to provide research infrastructure as well as supervised professional development in research and clinical trial implementation to assist institutions in IDeA-eligible States in establishing and maintaining pediatric clinical trial teams.

The Michael J. Fox Foundation seeks applications with potential for fundamentally altering disease course and/or significantly improving treatment of symptoms above and beyond current standards of care. Proposals must have a well-defined plan for moving toward clinical utility for Parkinson's disease (PD) patients. The Therapeutic Pipeline Program is open to industry and academic investigators proposing novel approaches or repositioning approved or clinically safe therapies from non-PD indications. Part of our Edmond J. Safra Core Programs for PD Research, the Therapeutic Pipeline Program advances Parkinson's disease therapeutic and intervention development along the pre-clinical and clinical path (i.e., both drug and non-pharmacological therapeutics, including gene therapy, biological, surgical and non-invasive approaches).