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The purpose of this Funding Opportunity Announcement (FOA) is to facilitate the design, conduct, and completion of clinical trials for improving prevention of human papillomavirus (HPV)-related cancers in human immunodeficiency virus (HIV)-infected individuals. To serve this goal, the FOA will support a network of international collaborative sites conducting meritorious and appropriately designed prevention clinical trials in the Latin American and Caribbean (LAC) region via a U54 Partnership Centers mechanism. Each proposed U54 Partnership Center must be based on a collaboration between a research institution in the United States (as the applicant institution) and partnering institution(s) in low- and middle-income countries (LMICs) in the LAC region. The proposed clinical trials should be focused on optimizing clinical prevention interventions among HIV-infected individuals, including immunoprevention (vaccination), screening and triage, and precancer treatment. Each Partnership Center application must propose a Clinical Trials Program that will develop and conduct three prevention clinical trials within the 5-year project period. As infrastructure supporting the Clinical Trials Program, each Partnership Center should include an Administrative and Coordinating Core, a Data Management and Statistical Core, and a Central Laboratory Core. Results of the clinical trials conducted through the Partnership Centers are expected to influence the development of clinical practice guidelines to improve preventive clinical care and reduce the burden of highly preventable HPV-related cancers in HIV-infected individuals.

(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 FY19 PRCRP Translational Team Science Award (TTSA) supports hypothesis-driven translational studies. These studies should be associated with a clinical trial. The proposed project should focus on research for the next-phase clinical trial or future clinical application. The TTSA is intended to support advanced translational studies that are based on results from clinical investigations. While funding for clinical trials is allowed, the TTSA is intended to support multi-investigator, multidisciplinary teams to perform clinical research studies and not only to fund a clinical trial. Research projects funded by the TTSA should address critical knowledge gaps in clinical outcomes, validate key research results, expand upon potentially game-changing results, or investigate novel clinical findings. New for FY19: The FY19 PRCRP TTSA Areas of Emphasis (strongly encouraged but not required): · Interventions to improve quality of life for cancer patients and/or survivors · Cancer prevention or early detection · Understanding metastatic disease to improve outcomes

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 purpose of this Funding Opportunity Announcement (FOA) is to accelerate the pace of translation of NCI-supported methods/assays/technologies (referred to as "assays") to the clinic. Specifically, the focus of this FOA is on the adaption and clinical validation of molecular/cellular/imaging markers (referred to as "markers" r "biomarkers") for cancer detection, diagnosis, prognosis, monitoring, and prediction of response in treatment, as well as markers for cancer control and prevention. Research applications may support the acquisition of well-annotated specimens from NCI-supported or other clinical trials or observational cohorts/consortia for the purpose of clinical validation of the assay. Research projects proposed for this FOA encourage multi-disciplinary interaction among scientific investigators, assay developers, clinicians, statisticians, and clinical laboratory staff. Clinical laboratory scientist(s) and statistical experts are highly encouraged to comprise integral parts of the application. This FOA is not intended to support early-stage development of technology or the conduct of clinical trials, but rather the adaption and validation of assays to the point where they could be integrated into clinical trials as investigational assays/tools/devices.

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.

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.

This purpose of this Funding Opportunity Announcement (FOA) is to provide a mechanism of support to research organizations interested in clinically translating already optimized quantitative imaging software tools capable of measuring or predicting the response of cancer to clinical therapies, or in translating imaging software tools for planning and validating radiation therapy treatment strategies in clinical trials. The quantitative software tools must have been developed and optimized during a performance period in the Quantitative Imaging Network (QIN) or under other separate funding. The proposed research effort should be an extension of the research that successfully completed the tasks of developing and optimizing the chosen software tools or data collection methods intended to facilitate clinical decision making during clinical trials. This FOA is intended to support the efforts of validating those software tools in prospective multisite clinical trials to test software tool performance and to demonstrate that the software tool can be integrated into clinical workflow with a minimum of disruption.

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 purpose of the NCI Pathway to Independence Award for Outstanding Early Stage Postdoctoral Fellows (K99/R00) program is to increase and maintain a strong cohort of new and talented, NCI-supported, independent investigators. This program is designed for postdoctoral fellows with research and/or clinical doctoral degrees who do not require an extended period of mentored research training beyond their doctoral degrees. The objective of this award is to facilitate a timely transition of these fellows from their mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. The program will provide independent NCI research support during this transition to help awardees to launch competitive, independent research careers. Researchers in the scientific areas of data science and cancer control science are especially encouraged to apply. 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 (RFA-CA-20-015).

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.

The Investigator-Initiated Translational Research Award (IITRA) supports translational research that will develop promising ideas in lung 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. However, Principal Investigators (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. This mechanism is intended to fund a broad range of translational studies, including, but not limited to, the following: * Studies advancing/translating in vitro and/or animal studies to applications with human samples/cohorts. * Late-stage preclinical work leading to/preparing for a clinical trial, e.g., Investigational New Drug (IND) application submission. * Correlative studies that are associated with an ongoing or completed clinical trial and projects that develop endpoints for clinical trials. Preliminary data to support the feasibility of the research hypotheses and research approaches are required; however, these data do not necessarily need to be derived from studies of lung cancer.

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.

This Funding Opportunity Announcement (FOA) supports the development of new exploratory research in cancer diagnosis, treatment, imaging, symptom/toxicity, and prevention clinical trials; correlative studies associated with clinical trials; novel cancer therapeutic, symptom/toxicity, and preventive agent development, radiotherapy development activities, and mechanism-driven combinations; and innovative preclinical studies--including the use of new clinically-relevant models and imaging technologies--which could lead to first-in-human clinical trials. The R21 mechanism is intended to encourage exploratory and developmental research projects by providing support for the early and conceptual stages of these projects. These studies may involve considerable risk, but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of cancer research (pre-clinical or clinical).

This Funding Opportunity Announcement (FOA) will support extramural research to investigate and mitigate challenges facing clinical assay development due to biopsy biospecimen preanalytical variability. The program will tie in with current efforts to optimize clinical biomarker assays utilized in NCI-sponsored clinical trials. Results from this research program will improve the understanding of how biopsy collection, processing, and storage procedures may affect all aspects of analytical performance for current and emerging clinical biomarkers, as well as expedite clinical biomarker assay development through the evidence-based standardization of biopsy handling practices. Critical information gained through these research awards may increase the reliability of clinical biomarker assays, reduce time requirements for assay development, and decrease assay failure during late-stage testing.

This Funding Opportunity Announcement (FOA) invites researchers to submit applications for support of clinical projects that address critical needs for clinical trial readiness in rare diseases. The initiative seeks applications that are intended to facilitate rare disease research by enabling efficient and effective movement of candidate therapeutics or diagnostics towards clinical trials, and to increase their likelihood of success through development and testing of rigorous biomarkers and clinical outcome assessment measures, or by defining the presentation and course of a rare disease to enable the design of upcoming clinical trials.

Vanderbilt (VU and VUMC, collaboratively) may choose one nominee for the new V Clinical Scholar Program from the V Foundation. To accelerate cancer treatment and cures, the V Foundation proposes to develop the careers of clinicians who will become leaders in developing programs of cancer clinical trials that are sequential and based on hypothesis-driven research. The competitive candidate will have a thorough knowledge of clinical trials and cancer biology as well as the ability to utilize new research discoveries for clinical intervention, the ability to develop a long-term plan to cure different forms of cancer, communicate with government agencies, and collaborate with the biotechnology and pharmaceutical industries to facilitate progress in clinical care.

The FY20 MRP Translational Research Award (TRA) supports hypothesis-driven, translational, high-impact research. The TRA mechanism encourages applications with mature research projects that specifically focus on critical scientific or clinical melanoma issues, which, if successfully addressed, have the potential to make a major impact. Important factors under consideration will be continuity of research, clinical applicability, and leveraging of clinical samples from clinical trials and/or biorepositories. The TRA supports identifying scientific outcomes, through rigorous, robust research, that are translatable toward treatment and/or preventive strategies. Proposed research should be mature and well developed. Research proposed should aim to accelerate promising findings toward clinical applicability and leverage research results to maximize impact. The TRA is not intended to study research into clinical utility of PD-1 in combination with other therapeutics, or studies utilizing established cell lines. Variety of DOD Melanoma research grants

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).

Through this funding opportunity announcement (FOA), the National Cancer Institute (NCI) proposes and will support the Cancer Prevention Clinical Trials Network (CP-CTNet), for which the goals are as follows: Design and conduct of early phase clinical trials to assess the safety, tolerability, and cancer preventive potential of agents and interventions of varying classes, many of which target molecules or processes known to be important during carcinogenesis. These trials include phase 0 (micro-dosing), phase I (dose-finding), and phase II (preliminary efficacy) clinical trials. Characterization of the effects of these agents and interventions on their molecular targets, as well as on other biological events associated with cancer development (such as cell proliferation, apoptosis, growth factor expression, oncogene expression, immune response) and correlation of these effects with clinical endpoints. Development of further scientific insights into the mechanisms of cancer prevention by the agents examined, including the development of novel potential markers as determinants of response.