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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.

(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.

The National Center for Complementary and Integrative Health (NCCIH) seeks to support interdisciplinary clinical research training to improve the capacity of the integrative health field to carry out rigorous research. This Funding Opportunity Announcement (FOA) solicits renewal applications to support training partnerships between institutions with research intensive environments (e.g., institutions with a Clinical and Translational Science Award (CTSA) or T32 programs) and institutions focused on clinical training of practitioners in complementary modalities and disciplines that have faculty with substantial interest in rigorous clinical research. The program will support mentored research training with hands-on mentored experiences in clinical research within NCCIH's Strategic Plan and didactic activities in clinical research methodology and integrative health. The funded training partnership is expected to generate a cadre of clinician scientists who participate in multi-disciplinary teams engaged in complementary and integrative health research. This FOA does not allow appointed T90 Trainees or R90 Participants to lead an independent clinical trial but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor.

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 NIH Office of Research on Women's Health (ORWH) and participating NIH Institutes and Centers invite institutional career development award applications for Building Interdisciplinary Research Careers in Women's Health (BIRCWH) Career Development Programs, hereafter termed "Programs". Programs will support mentored research career development of junior faculty members, known as BIRCWH Scholars, who have recently completed clinical training or postdoctoral fellowships, and who will be engaged in interdisciplinary basic, translational, behavioral, clinical, and/or health services research relevant to the health of women and, where appropriate, the use of both sexes to better understand the influence of sex as a biological variable on health and disease. This Funding Opportunity Announcement (FOA) allows appointment of Scholars proposing to serve as the lead investigator of an independent clinical trial; or proposing a separate ancillary clinical trial; or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development. The clinical trial must be a NIH-defined clinical trial. Scholars may also propose fundamental research or human subjects research that is not a clinical trial.

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 overarching purpose of this Funding Opportunity Announcement (FOA) is to promote the validation of strong candidate biomarkers and endpoints for pain that can be used to facilitate the development of non-opioid pain therapeutics from discovery through Phase II clinical trials. Specifically, the focus of this FOA is on advanced analytical and clinical validation of pain biomarkers, biomarker signatures, and/or endpoints using retrospective and/or prospective methods. It is assumed that: 1) a candidate biomarker has already been identified, 2) assay technology has already been developed, and 3) a working hypothesis regarding Context of Use is in place. Research supported by this FOA will ultimately demonstrate that biomarker or endpoint change is reliably correlated with variables such as clinical outcome, pathophysiologic subsets of pain, therapeutic target engagement or response to a pain therapeutic; in addition, biomarker response will demonstrate specificity to the pain condition or therapeutic as demonstrated at multiple clinical sites. The goal of this FOA is to facilitate the advancement of robust and reliable biomarkers, biomarker signatures and endpoints of pain to application in clinical trials (Phase II clinical trials and beyond) and in the spectrum of clinical practice.

The FY19 PCRP Translational Science Award mechanism supports translational research that will develop promising ideas in prostate 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. As such, applications must include a detailed transition plan that articulates the pathway to moving the project's findings to the next phase of development after successful completion of the award, and how the Principal Investigator (PI) will continue advancing the research toward making a clinical impact, even if clinical impact is not an immediate outcome. However, 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. The potential impact of the research is expected to be significant and go beyond an incremental advance. Proposed projects may include basic, translational, population science, and/or clinical research, but must demonstrate clinical relevance.

This Funding Opportunity Announcement (FOA) is to encourage Research Project Grant (R01) applications to pursue clinical observational (CO) studies to obtain data necessary for designing clinical studies for musculoskeletal, rheumatic, or skin diseases or conditions. A future clinical study may include a clinical trial or an observational study. Research data from observational studies supported by this FOA can enhance clinical study design by providing essential information about disease symptoms, stages and timing of disease progression, comorbid conditions, availability of potential research participants, and outcomes that are important to patients. They also can facilitate efforts to develop and/or validate objective biomarkers or subjective outcome measures for use in a future clinical study. Applicants to this FOA are encouraged to propose studies that address significant obstacles or questions in the design of a clinical project, such as determining the appropriate primary or secondary outcome measures, or identifying the stages of disease during which patients are most likely to respond to an intervention. Only observational studies will be supported through this FOA.

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 this Funding Opportunity Announcement is to solicit applications for the Vaccine and Treatment Evaluation Units (VTEUs) to implement clinical site protocols (clinical research, clinical trials) for evaluating vaccines, other preventive biologics, therapeutics, diagnostics, including prognostic and predictive markers, and devices for the treatment and prevention of infectious diseases as part of NIAID Infectious Diseases Clinical Research Consortium (IDCRC). A companion FOA solicits applications for the Leadership Group for the Infectious Diseases Clinical Research Consortium, hereafter referred to as the Leadership Group (LG), which provides for overall administrative and scientific leadership for the clinical research and clinical trials conducted. While the primary scientific focus will be on product evaluation for NIAID priority areas, including malaria/neglected tropical diseases, sexually transmitted infections, respiratory infections, and enteric diseases, the VTEUs must also provide surge capacity to address emerging infectious diseases

The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications for the Vaccine and Treatment Evaluation Units (VTEUs) to implement clinical site protocols (clinical research, clinical trials) for evaluating vaccines, other preventive biologics, therapeutics, diagnostics, including prognostic and predictive markers, and devices for the treatment and prevention of infectious diseases as part of NIAID Infectious Diseases Clinical Research Consortium (IDCRC). The VTEUs coordinate with the Leadership Group (LG) for the IDCRC, a program which provides for overall administrative and scientific leadership for the clinical research and clinical trials conducted. This initiative seeks to fund additional VTEUs with a specific focus on enhancing capability and capacity of current research in controlled human infection models for malaria and influenza, and implementation of treatment and prevention trials in endemic areas for malaria and neglected tropical diseases. While the scientific focus will be on product evaluation for NIAID priorities for this FOA, including malaria/neglected tropical diseases, the VTEUs must also provide capacity to perform clinical research on sexually transmitted infections, respiratory infections, and enteric diseases in infected patients and healthy volunteers, in addition to providing surge capacity to address emerging infectious diseases.

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.

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).

This announcement provides funds to recipients to partner with health systems and individual primary care clinics to implement evidence-based interventions (EBIs) to increase colorectal cancer (CRC) screening uptake among applicant defined populations age 50-75 years that have CRC screening rates lower than the national, regional, or local rate. Recipients will: 1) establish partnerships with health systems and primary care clinics to implement at least two of four EBIs recommended in The Community Guide (client reminders; provider reminders, reduction of structural barriers, and provider assessment and feedback); 2) establish partnerships with organizations that provide expertise to support the implementation of EBIs in primary care clinics; 3) conduct a formal assessment of each clinics capacity/readiness to implement EBIs; 4) utilize the clinic assessment to select appropriate EBIs to implement; 5) provide resources to partner clinics to provide and support completion of follow-up colonoscopies after a positive or abnormal screening test; and 6) collect and submit high-quality clinic-level data including baseline and annual CRC screening rates.

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 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 urologic disorders research. Studies should address important clinical and translational questions that 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 prevention, diagnosis or treatment of urologic disorders.

The purpose of this Funding Opportunity Announcement is to solicit applications for the Vaccine Treatment and Evaluation Units (VTEUs) to implement clinical site protocols (clinical research, clinical trials) for evaluating vaccines, other preventive biologics, therapeutics, diagnostics, including prognostic and predictive markers, and devices for the treatment and prevention of infectious diseases as part of NIAID Infectious Diseases Clinical Research Consortium (IDCRC). A companion FOA solicits applications for the Leadership Group for the Infectious Diseases Clinical Research Consortium, hereafter referred to as the Leadership Group (LG), which provides for overall administrative and scientific leadership for the clinical research and clinical trials conducted. While the primary scientific focus will be on product evaluation for NIAID priority areas, including malaria/neglected tropical diseases, sexually transmitted infections, respiratory infections, and enteric diseases, the VTEUs must also provide surge capacity to address emerging infectious diseases.

The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications for Clinical Trials Units (CTUs) to provide scientific and administrative expertise as well as the infrastructure to conduct clinical studies developed by NIH HIV/AIDS Clinical Trials Networks. Clinical Trials Units will participate in the development of trials and provide clinical sites, local laboratory capacity, and pharmacy support for two or more HIV/AIDS Clinical Trials Networks.

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.