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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.

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).

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 multi-site exploratory and confirmatory clinical trials focused on promising interventions, as well as biomarker-or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery.  Successful applicants will collaborate and conduct the trial within the NIH StrokeNet.  Following peer review, NINDS will prioritize trials among the highest scoring to be conducted in the NIH StrokeNet infrastructure. The NIH StrokeNet National Coordinating Center (NCC) will work with the successful applicant to implement the proposed study efficiently and the National Data Management Center (NDMC) will provide statistical and data management support.  The NIH StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol.

This FOA encourages applications for multi-site exploratory and confirmatory clinical trials focused on promising interventions, as well as biomarker-or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery. Successful applicants will collaborate and conduct the trial within the NIH StrokeNet. Following peer review, NINDS will prioritize trials among the highest scoring to be conducted in the NIH StrokeNet infrastructure.

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

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 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.

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 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.

(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 Announcement (FOA) invites applications that propose to develop and implement early stage (Phase I or II) clinical trials of promising pharmacological and non-pharmacological interventions in individuals with age-related cognitive decline and in individuals with Alzheimer's disease (AD) across the spectrum from pre-symptomatic to more severe stages of disease, as well as to stimulate studies to enhance trial design and methods.

This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose exploratory and confirmatory clinical trials focused on promising interventions, as well as biomarker-or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery. The program will utilize the cooperative agreement mechanism to enable milestone-drive projects.

Since 1998, ADDF has provided more than $29 million in funding for early stage clinical drug trials for Alzheimer's disease and related dementias. To help propel novel drugs into the clinic, ADDF also has provided over $6.5 million in support of final preclinical studies required by regulatory agencies for the initiation of clinical research studies. The goal of the foundation's PACT program is to increase the number of innovative treatments tested in humans for Alzheimer's disease and related dementias. To that end, the program will fund clinical trials through Phase 2a of novel drug candidates, including small molecules and biologics (antibodies, oligonucleotides, peptides, gene therapies, cell therapies); proof-of-concept biomarker-based trials in patients for repurposed/repositioned drugs; and regulatory studies for investigational new drug (IND)/clinical trial application preclinical packages that are required before testing novel drugs in human subjects. Proposed molecular targets will be evaluated based on the strength of available evidence linking the target to the disease and demonstrating that modulating its biological activity will improve symptoms or modify disease progression. Current target areas of interest include but are not limited to neuroprotection, inflammation, vascular function, mitochondria and metabolic function, proteostasis, ApoE, epigenetics, and synaptic activity and neurotransmitters.

The ADDF seeks to support comparative effectiveness research, prevention clinical trials, and epidemiological studies that probe whether the use or choice of drugs alters the risk for dementia or cognitive decline. Specifically, the Prevention Beyond the Pipeline RFP supports: * Studies Leveraging the Consortium of Cohorts for Alzheimer's Prevention Action (CAPA) * Comparative Effectiveness Research: Methods may include randomized trials or epidemiology. * Studies of Cognitive Decline and Cognitive Reserve: Methods may include epidemiology or clinical trials. Current target areas of interest include: - Epigenetics - Inflammation - Mitochondria & metabolic function - Neuroprotection - Proteostasis - Synaptic activity and neurotransmitters - Vascular function - Other aging targets (e.g. senescent cells) - Other novel targets or pathways that are supported by compelling evidence demonstrating a rational biological connection to age-related cognitive decline or dementia risk   

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 this Funding Opportunity Announcement (FOA) is to support rigorous clinical validation of a candidate biomarker using retrospective and/or prospective methods in a manner that is consistent with the purpose of the biomarker. This FOA assumes that: 1) a candidate biomarker has already been identified, 2) an analytical method has been developed and validated that is consistent with the purpose of the biomarker and 3) a working hypothesis regarding context of use is in place. The goal of this FOA is to facilitate the advancement of robust and reliable biomarkers of diseases that fall within the mission of NINDS to application in clinical trials and practice (Phase II clinical trials and beyond).

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.