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Quality Review of ClinicalTrials.gov
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Resource Development
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AHRQ, FDA
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NLM, CC, NCCAM, NCI, NCATS, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NIMHD, NINDS, NINR, OD
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ClinicalTrials.gov is an NLM-operated database of summary protocol and results information from publicly and privately funded clinical research. As of October 2010, the database included over 96,000 studies conducted in 174 countries with over 2,300 summary results. NLM is collaborating with FDA and other parts of NIH to implement the statutory requirements of the Food and Drug Administration Amendments Act of 2007 and working together on a project with CTTI (Clinical Trials Transformation Initiative) to create a ClinicalTrials.gov Analysis Data Set. NLM and AHRQ are collaborating on conducting quality reviews (e.g., evaluate for internal consistency, meaningful entries, formatting) of summary results information.
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Racial and Ethnic Approaches to Community Health Across the U. S. (REACH US)
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Research Initiative
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CDC
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NIMHD
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The purpose of the REACH U.S. Program is for organizations serving racial and ethnic minority populations at increased risk for infant mortality, diabetes, cardiovascular diseases, Asthma, Hepatitis B, deficits in breast and cervical screening and management, deficits in child and/or adult immunization rates to develop, implement, and evaluate innovative community level intervention demonstrations which could be effective in eliminating health disparities. The racial and ethnic groups targeted by REACH U.S. include: African-Americans, Asian-Americans, Hawaiian Pacific Islanders, Hispanic-Americans, and American Indians or Alaskan Native populations.
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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. 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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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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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
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This activity is sponsored by the Clinical Pharmacology Program, Office of Clinical Research Training and Medical Education (OCRTME) at the NIH Clinical Center and it consists of elective rotations at the Office of Clinical Pharmacology (OCP) and the Office of New Drugs (OND)- FDA/CDER 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 Clinical Center 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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Recovery Act Limited Competition: Building Sustainable Community-Linked Infrastructure to Enable Health Science Research (RC4)
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Research Initiative
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AoA
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NIA, NCI, NCATS, NEI, NHGRI, NHLBI, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIMH, NIMHD, NINDS, NINR, NLM, OD/DPCPSI/OBSSR
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To develop or expand needed infrastructures that will fundamentally transform collaboration and communication between academic health centers and local communities. Such collaborative infrastructures are essential to advance the health science research enterprise while ensuring that important research findings are effectively disseminated and implemented to improve public health and advance health care delivery.
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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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Registry and Surveillance System in Hemoglobinopathies (RuSH)
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Resource Development
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CDC, HRSA, OS
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NHLBI, NICHD, NIDDK
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RuSH is a system to collect information on people living with hemoglobinopathies (sickle cell disease and thalassemia) in six states.
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Registry of Patient Registries
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Resource Development
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AHRQ
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NLM
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This project aims to develop a central source for accessing multiple levels of information related to patient registries.
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