Group items tagged

The purpose of the NIH Midcareer Investigator Award in Patient-Oriented Research (K24) is to provide support to mid-career health-professional doctorates for protected time to devote to patient-oriented research (POR) and to act as research mentors primarily for clinical residents, clinical fellows and/or junior clinical faculty. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing to lead basic science experimental studies involving humans, referred to in NOT-OD-18-212 as prospective basic science studies involving human participants. These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should submit under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. Studies conducted with specific applications toward processes or products in mind should submit under the companion PA-18-393.

This funding opportunity announcement will supportprojectsto enhance the availability and delivery of safe blood to be used for transfusion in patients from low or lower-middle income countries (LLMICs) in Sub-Saharan Africa (SSA). For example, ensuring that children with malaria or sickle cell disease and pregnant women who suffer from obstetric hemorrhage have access to safe transfusion therapies is of high programmatic interest. BLOODSAFE will support projects that develop and test feasible, effective and sustainable strategies to increase the number of safe blood donors, to improve quality and safety of blood supplies, and to enhance blood delivery to patients in need, especially in remote settings.

The purpose of this RFA is to encourage studies on reproductive health, fertility and fertility preservation/treatment options in patients born with a serious chronic condition who can now expect to survive into adulthood healthy enough to consider their reproductive health and fertility options. The underlying pathophysiology of diseases such as sickle cell anemia, thalassemia, and cystic fibrosis, among others, and/or the cumulative effects of their treatment, can compromise reproductive health. This RFA encourages teams of scientists with expertise in the realm of the particular disease and in reproductive health and fertility to work together to understand the effects of the diseases and/or their treatments on parameters of reproductive health, and to identify ways to preserve, protect, or treat and reproductive deficits in these patients.

This Funding Opportunity Announcement (FOA) is associated with the Beau Biden Cancer Moonshot InitiativeSM that is intended to accelerate cancer research. The purpose of this FOA is to promote research on developing the descriptive, inferential, and graphical statistical methods for data generated in clinical trials including Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) items. Specifically, this FOA targets the following area designated as a scientific priority by the Blue Ribbon Panel (BRP): Accelerate research that can identify approaches to monitor and manage patient-reported symptoms.

The PRMRP Investigator-Initiated Research Award (IIRA) is intended to support studies that will make an important contribution toward research and/or patient care for a disease or condition related to at least one of the Congressionally directed FY13 PRMRP Topic Areas. The rationale for a research idea may be derived from a laboratory discovery, population-based studies, a clinician's first-hand knowledge of patients, or anecdotal data. Applications must include relevant data that support the rationale for the proposed study. These data may be unpublished or from the published literature. Research projects may focus on any phase of research from basic laboratory research through translational research, including preclinical studies in animal models and human subjects, as well as correlative studies associated with an existing clinical trial. Research involving human subjects and human anatomical substances is permitted; however, this award may not be used to conduct clinical trials.

This Funding Opportunity Announcement (FOA) is limited to those Program Director(s)/Principal Investigator(s) of Rare Diseases Clinical Research Consortia (RDCRC) who received an NINDS award under the Rare Diseases Clinical Research Network (RDCRN) program through RFA-TR-13-002, or an NCI award through RFA-OD-08-001. The purpose of this limited competition FOA is to allow these NINDS- and NCI-awarded consortia an opportunity to compete for another four years of participation in the RDCRN. The RDCRN is a collaborative and coordinated network of Clinical Research Consortia comprised of investigators and patient advocacy groups committed to investigation of rare diseases working in partnership with a Data Management Coordinating Center (http://grants.nih.gov/grants/guide/rfa-files/RFA-TR-13-003.html) to enhance communication and sharing of resources in a multidisciplinary approach. This FOA intends to support: 1) collaborative clinical research in rare diseases, including longitudinal studies of individuals with rare diseases, clinical studies and/or clinical trials; 2) career development and advancement opportunities for clinical investigators in rare diseases research; 3) pilot/demonstration (proof of concept) clinical research projects; and 4) access to information related to rare diseases for basic and clinical researchers, physicians, patients, and the lay public.

This Funding Opportunity Announcement (FOA) invites U01 applications for the establishment of a clinical consortium, composed of one Coordination and Data Management Center (CDMC) and up to 9 Clinical Centers (CC), to conduct studies on chronic pancreatitis (CP) and factors that increase the risk of pancreatic cancer in patients (children and adults) with CP, pancreatogenic (type 3c) diabetes (T3cDM) and in patients with newly diagnosed diabetes.

This Funding Opportunity Announcement (FOA) invites U01 applications for the establishment of a clinical consortium, composed of one Coordination and Data Management Center (CDMC) and up to 9 Clinical Centers (CC), to conduct studies on chronic pancreatitis (CP) and factors that increase the risk of pancreatic cancer in patients (children and adults) with CP, pancreatogenic (type 3c) diabetes (T3cDM) and in patients with newly diagnosed diabetes.

This FOA will support the strengthening and sustainability of HIV in-service training and mentorship of HCW, as well as patient support programs through national and county systems, including NHCSC and NHITC, in Kenya. The expected outcomes include increased accountability, sustainability, and efficiency in HCW training; increased skilled HCW providing HIV services adherent to guidelines; and improved patient treatment adherence, retention, and active participation in HIV care management

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 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.

Half of all Crohn's disease patients will develop disease complications, one of which is development of fibrotic strictures (fibrostenosis) leading to GI tract obstruction and severe clinical consequences. Fibrostenosis is also a serious problem for ulcerative colitis, with approximately 8 percent incidence over a lifetime. Currently there is no clinical solution for preventing or treating fibrostenosis in patients with inflammatory bowel disease (IBD) except for surgical intervention. Therefore, there is a great unmet need to understand fibrotic complications in IBD and how to prevent and treat them.

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.

The purpose of this Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), is to support the Cooperative Human Tissue Network (CHTN). The goal for CHTN is to collect and distribute high quality human tissue specimens to facilitate basic and early translational cancer research, as well as assay development. The CHTN is designed as a unique biospecimen resource in that it is based on prospective collection and distribution of samples upon specific investigators requests. Samples to be collected from patients include pre-cancerous, cancerous, and benign neoplastic tissues, as well as specimens corresponding to non-neoplastic diseases and uninvolved tissues. This FOA solicits applications for CHTN awards from institutions/teams capable of contributing to the mission of CHTN by: (1) providing prospective investigator-defined procurement of high-quality malignant, benign, diseased, and uninvolved (normal adjacent) tissues and fluids from patients throughout North America and elsewhere; (2) assisting individual investigators with regard to specific specimen needs of their research; (3) assisting in developing and disseminating knowledge on high quality practices for successfully operating a biospecimen repository; and (4) educating the community about the importance of the availability of high quality human tissue specimens for medical research. Depending on their profile and capabilities, applicants must indicate whether they propose to function as the CHTN adult biospecimen division or the pediatric specimen division. Nonetheless, it will be acceptable for an adult biospecimen division, if capable, to contribute pediatric samples for networked requests. This FOA is open to all qualified applicants irrespective of their previous association with the CHTN.

The Agency for Healthcare Research and Quality (AHRQ) seeks applications to disseminate patient-centered outcomes research (PCOR) findings directly to primary care practices and support practices in implementing PCOR clinical and organizational findings. Applicants must propose a comprehensive plan that uses evidence-based strategies designed to improve the delivery of patient-centered approaches to identifying and managing unhealthy alcohol use among adults, including screening and brief intervention (SBI) and medication assisted therapy (MAT).

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)s Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) conducts multi-site, multi-disciplinary studies of Lower Urinary Tract Dysfunction (LUTD) to better define clinical phenotype, to better describe the impact and diversity of symptoms, and to develop new patient-centric tools for improved measurement of clinical symptoms, all with the goals of informing future clinical studies and improving patient care. The purpose of this Limited Competition Funding Opportunity Announcement (FOA) is to solicit applications from the current LURN Data Coordinating Center for a second five-year Project Period.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)s Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) conducts multi-site, multi-disciplinary studies of Lower Urinary Tract Dysfunction (LUTD) to better define clinical phenotype, to better describe the impact and diversity of symptoms, and to develop new patient-centric tools for improved measurement of clinical symptoms, all with the goals of informing future clinical studies and improving patient care. The purpose of this Limited Competition Funding Opportunity Announcement (FOA) is to invite applications from current LURN Research Sites for a second five-year Project Period.

The purpose of this FOA is to fund research centers that will establish longitudinal cohorts in rare HLBS diseases to investigate unaddressed research questions using epidemiologic study designs and methods that are appropriate for conditions affecting fewer than 200,000 persons in the US. These observational cohort studies should be designed to provide an evidence base for future interventional studies, including clinical trials; for developing better diagnostics than those that are currently available; for answering early translational questions; or for broader implementation of guidelines for managing these diseases. This program will provide opportunities to advance rare disease research using genetics and deep phenotyping to characterize the disease and to identify disease sub-types; to use data science methods that integrate clinical and patient-reported outcomes (PROs) with laboratory, imaging, environmental and -omics data to understand the natural history of disease; to generate data that differentiate patients with the same morphological phenotype but different genetic mutations and severity of outcomes; to elucidate genotype-phenotype interactions and multisystem phenotyping to develop reliable and valid predictive tools to determine who will respond to which treatments and when to intervene; and to encourage innovative methods such as telemedicine to include participants with rare diseases located in remote locations.

The Investigator-Initiated Research Award supports highly rigorous, high-impact research projects that have the potential to make an important contribution to MS research and/or patient care. Research projects may focus on any phase of research, excluding clinical trials. The rationale for a research idea may be derived from laboratory discovery, clinical trial results, population-based studies, a clinician's firsthand knowledge of patients, or anecdotal data. Applications must include preliminary and/or published data that are relevant to MS and the proposed research project.