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Quantitative data mining for drug-adverse event safety signal detection using MEDLINE
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Research Initiative
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FDA
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NLM
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The objective of this initiative between the National Library of Medicine (NLM) Cognitive Science Branch and the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA) is to develop a mutually beneficial automated data mining analytical tool in which NLM’s electronic databases and resources (including MEDLINE) are utilized to support the FDA’s mission related to enhancing postmarket drug safety surveillance and safe use.
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RABRAT (Radiobiology Bioterrorism Research and Training Group)
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Meeting/ Workshop
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FDA, OS
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NCI
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Monthly meetings to discuss research initiatives, funding opportunities, training, conferences, publications and other events and information related to preparing the U.S. Government to respond to nuclear terrorism.
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Racial disparities in prostate cancer incidence rates by census division in the United States, 1999-2008
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Research Initiative
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CDC
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NCI
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An analysis of the National Program of Cancer Registries database to assess census division differences by race (white, black) in trends of prostate cancer.
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Radiation Emergency Medical Management (REMM)
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Resource Development
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CDC, OS
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NLM, NCI
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This activity is to develop a comprehensive web resource. Radiation Emergency Medical Management (REMM) is a mechanism to collect, evaluate, collate, store and make available electronically to health care professionals immediate, up-to-date, evidence-based clinical information they would use to treat civilian patients and others affected by radiation incidents.
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Radiation/Nuclear Biodosimetry Team
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Committee, Work group, Advisory group, or Task Force
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OS
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NIAID
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Team members participate in the review of white papers, full proposals and progress reviews for Biomedical Advanced Research and Development Authority (BARDA)-funded contracts supporting the development of novel biodosimetry platforms.
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Radiation/Nuclear Technical Evaluation Review Panel
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Committee, Work group, Advisory group, or Task Force
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OS
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NIAID
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The National Institute of Allergy and Infectious Diseases (NIAID) participates on the Radiation/Nuclear Technical Evaluation Review Panel to review white papers and proposals received by the U.S. Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) for the development of radiation nuclear medical countermeasures. NIAID provides scientific and programmatic critiques and reviews of selected submissions.
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Randomized Intervention in Children with Vesicoureteral Reflux (RIVUR)
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Research Initiative
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OS
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NIDDK
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The multicenter, randomized, double-blind, placebo-controlled RIVUR trial is designed to determine whether daily antimicrobial prophylaxis is superior to placebo in preventing recurrence of UTI in children with VUR. The study is designed to recruit 600 children (approximately 300 in each treatment group) over an 18-24 month period. The primary endpoint is recurrence of UTI. Quality of life, compliance, safety parameters, utilization of health resources, and change in VUR will be assessed periodically throughout the study.
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Rapid State Evaluation Reviewer
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Research Initiative
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FDA
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NICHD
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The purpose of this interagency agreement was for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to provide the Center for Tobacco Products of the U.S. Food and Drug Administration with an employee to participate in an objective review panel for the Rapid State Evaluation Blanket Purchase Agreement. This includes all activities involved in the preparation and attendance for review. The NICHD employee served on the Project Advisory Group (PAG). The PAG members served as an advisory and review body on technical matters during the acquisition process.
Activities for the PAG members, included: Conduct individual review and assessment of each proposal based on the Request for Proposal (RFP) instructions, evaluation criteria; Participate in consensus evaluation sessions to agree upon panel findings and consensus comments, Clarification questions, and factor, sub-factor, and proposal adjectival ratings; Participate in the oral presentations; Review and approve delivery of PAG report to the Contract Officer; and Perform a technical review of the Business Proposals. In addition the employee performed the following activities: Examine each proposal in detail including any additional material such as draft project management and staffing plans; Assess how well the proposal and additional material satisfy each Evaluation Factor, Sub-Factor, and Criteria; Document the assessment – criteria by criteria and factor by factor – by citing specific proposal references and writing rationale detailed comments; Assign the appropriate comment ratings; and Craft clarification/discussion questions for Offerors if appropriate.
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Reasons for Geographic and Racial Differences in Stroke (REGARDS) Study - Occupational Supplement
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Health Survey
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CDC
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NINDS
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The goal of this study is to identify the extent to which occupational exposure contributes to cardiovascular disease in a racially diverse, population-based sample, with emphasis on health disparities secondary to racial/ethnic characteristics.
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Reciprocal Educational and Training Partnerships between FDA/CDER and the NIH Clinical Center
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Training Initiative
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FDA
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CC, NCI, NIAID, NIMH, NINDS
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This activity is sponsored by the Clinical Pharmacology Program, Office of Clinical Research Training and Medical Education (OCRTME) at The National Institutes of Health (NIH) Clinical Center (CC) and it consists of elective rotations at the Office of Clinical Pharmacology (OCP) and the Office of New Drugs (OND) of the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research for NIH staff with a primary focus on clinical fellows and research fellows who expressed an interest in learning more about FDA regulatory sciences applicable to drug development research. Rotating fellows are mentored by FDA staff on the required elements of an Investigational New Drug (IND) application and the key elements of the FDA review process from a regulatory perspective. This program also established a mechanism for FDA scientific reviewers at the OCP to rotate at the NIH CC and to interact with members of a clinical research team, thus acquiring a better perspective on clinical research protocol implementation and the requirements of an Institutional Review Board (IRB) at the NIH.
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