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Endocrinologic and Metabolic Drugs Advisory Committee
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Committee, Work group, Advisory group, or Task Force
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FDA
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NIAID
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This Committee provides expertise in the evaluation of evidence submitted by pharmaceutical companies to the FDA for drug approval.
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Enhancing the National Death Index (NDI)
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Resource Development
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CDC
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NIA, NCI, NHLBI
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This agreement will enable the Centers for Disease Control and Prevention (CDC) National Center for Health Statistics to expedite the processing of state death certificate data for annual updates to the National Death Index (NDI).
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Enterovirus D68 (EV-D68) Mouse Model Development For Acute Flaccid Myelitis
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Research Initiative
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FDA
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NIAID
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The purpose of this collaboration is to develop an animal model of Enterovirus D68 to understand disease progression and outcomes such as acute flaccid myelitis.
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Ethical, Legal and Social Issues (ELSI) Sub-study in the Biospecimen Pre-Analytical Variables (BPV) Project
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Research Initiative
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OS
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NCI, CC
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Pre-Analytical Variables (BPV) Ethical Legal and Social Implications (ELSI) Substudy is a study of the ethical, legal and social implications related to the informed consent process for biobanking. The ELSI study is designed to address current issues related to informed consent for biobanking, particularly the issues of consent for broad future research use and return of research results. The objective of the ELSI Substudy is to assess research participant comprehension and concerns related to informed consent and data sharing for biobanking across the diverse patient populations included in the BPV program. The intent of this evaluation is to improve our understanding of the issues that impact donor participation in such programs and to identify factors that may result in decreased rates of donor participation. This study provides a unique and unprecedented opportunity to address these issues in a diverse patient population of actual biospecimen contributors approached for consent using a highly harmonized informed consent document. Each Biospecimen Source Site collecting tumor tissue from surgical procedures is participating in the ELSI study. To date, several hundred interviews with BPV participants have been submitted for analysis. Data collection concluded in May of 2015 and data analysis is in progress.
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European-US Pediatric Formulations Excipients Committee
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Committee, Work group, Advisory group, or Task Force
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FDA
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NICHD
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Multinational academic, industry, and regulatory group convened to determine toxicity of excipients in pediatrics. Accomplishments include developing a database that is tested both in the EU and US.
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Evaluating Community-Clinical Engagement Models
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Meeting/ Workshop
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CDC
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NHLBI, NCI, NICHD, OD/DPCPSI/OBSSR, OD/DPCPSI/ODP
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Evaluating Community-Clinical Engagement Models describes the strategies used by community engagement programs and models that enable health care and communities to collaborate to address childhood obesity. This effort is part of the National Collaborative on Childhood Obesity Research, under the NIH Obesity Research Task Force and involves, NIH, CDC, USDA and RWJF. Describes the degree to which current efforts have undergone evaluations, including process measures, metrics, or indicators that have been used; identify the value that a model provides for stakeholders and leaders (e.g., community or employee health impact) and funders (e.g., organization mission); develop an evaluation framework that can be used to motivate program developers, stakeholders, and funders; and provide recommendations to enhance future research and dissemination.
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Evaluation of Patient Reported Outcomes Following LASIK Surgery
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Research Initiative
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FDA
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NEI
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This will be a prospective, questionnaire-based study conducted by the U.S. Navy Refractive Surgery Center San Diego in collaboration with the U.S. Food and Drug Administration’s Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices. The primary purpose is to quantify the satisfaction and health related quality of life of 500 active duty patients over a period of six months following state-of-the-art laser in situ keratomileusis (LASIK). The questionnaire to be used will be a new instrument which, once validated in this study, might be employed in future clinical studies that include civilian refractive surgery centers in the U.S.
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Evidence-Based Review & Report Program
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Resource Development
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AHRQ
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OD/DPCPSI/ODP, NCCIH
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This Congressionally mandated program reviews current scientific evidence on the efficacy and safety of dietary supplements; identifies research needs; and prepares reports of their findings.
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Extracellular Ribonucleic Acid (RNA) Communication
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Research Initiative
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FDA
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OD/DPCPSI, NCATS, OD/DPCPSI/OSC
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Recent advances have indicated that ribonucleic acids (RNAs) can play a role in a variety of complex cellular functions, including newly discovered mechanisms of cell-to-cell communication. RNA can be exported from cells in extracellular vesicles or bound to lipids or proteins, to circulate through the body and affect cells at a distance. However, the actual impact of the extracellular RNAs, or exRNAs, is currently unknown. NIH and FDA intend to collaborate and coordinate efforts towards the preclinical and clinical use of exRNAs to address human health and disease.
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Eye Research Collaboration
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Other
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FDA
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NEI
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National Eye Institute (NEI) investigator Rachel Caspi is collaborating with Drs. Daniela Verthelyi and Raymond Donnelly of the Food and Drug Administration (FDA) on uveitis research. Uveitis is an autoimmune disease that targets the eye. If left untreated the disease can cause permanent vision loss. Current treatments consist of steroids to suppress the immune system. However, chronic use of these drugs has many side-effects and complications.
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