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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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Enhanced Comprehensive HIV Prevention Planning (ECHPP)/12-Cities Initiatives
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Research Initiative
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CDC, HRSA, IHS, SAMHSA
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NIMH, NIAID
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NIMH staff have participated in workgroups to inform the implementation of the Enhanced Comprehensive HIV Prevention Planning (ECHPP)/HHS Twelve Cities Project. This project is funded by the CDC''s Division of HIV/AIDS Prevention. The project aims to maximize the impact of HIV prevention in the twelve metropolitan areas with the highest AIDS prevalence in the United States.
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Enhanced Comprehensive HIV/AIDS Prevention Plan Cross-Agency Programmatic Workgroup
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Committee, Work group, Advisory group, or Task Force
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CDC, HRSA, IHS, OS
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NIAID, NIMH
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The purpose of this group is to enhance federal coordination in support of the National HIV AIDS Strategy, specifically related to the Enhanced Comprehensive HIV/AIDS Prevention Plan funded by the CDC.
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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/National Center for Health Statistics to expedite the processing of state death certificate data for annual updates to the NDI.
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Environmental Tobacco Smoke Exposure and Mortality Among Nonsmokers
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Research Initiative
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CDC
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NCI
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An investigation of environmental tobacco smoke exposure and mortality among nonsmokers in the National Health and Nutrition Examination Survey (NHANES) study.
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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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This Substudy is part of ongoing efforts by the Cancer Human Biobank (caHUB) program to improve effectiveness and generate best practices for the biospecimen research community. The Biospecimen 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 will be designed to address current issues related to informed consent for biobanking, particularly the issue of consent for broad future research use, and will be approached in a two-step fashion.
The objective of the ELSI Substudy is to assess research participant comprehension and concerns related to informed consent 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 will provide 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 (BSS) collecting tumor tissue from surgical procedures shall ensure participation in the ELSI study.
Both BPV participants and decliners will be surveyed, using two different survey instruments.
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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 will be tested both in the EU and US this year
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Evaluate the Efficacy of an Antiviral Drug, Tenofovir
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Research Initiative
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CDC
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NICHD
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The purpose of this Interagency Agreement is to continue to establish a formal working relationship between CDC and NICHD as co-sponsors of a multicenter clinical study to evaluate the efficacy of an antiviral drug, tenofovir, for prevention of hepatitis B virus (HBV) mother-to-child transmission from HBV-infected mothers with high HBV viral load. The study evaluates the critical issue of prevention of mother-to-child transmission (MTCT) of HBV in the high risk situation of elevated maternal HBV virus load [HBV e antigen positive (HBeAf+] mothers). Infants infected at birth with HBV are at high risk of both cirrhosis and liver cancer during adulthood.
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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 Methodology Workshop on Polycystic Ovary Syndrome
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Meeting/ Workshop
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AHRQ
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OD/DPCPSI/ODP, NICHD
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The Office of Disease Prevention coordinates the development of Evidence-based Methodology Workshops (EbMW) that seek to identify methodological and scientific weaknesses in a scientific area and move the field forward through an unbiased and evidence-based assessment of a complex clinical issue. The first workshop in this program focused on polycystic ovary syndrome (PCOS), a common hormone disorder that affects approximately 5 million reproductive-aged women in the United States. The workshop was designed to clarify: 1) benefits and drawbacks of using the Rotterdam Criteria, 2) the condition’s causes, predictors, and long-term consequences, and 3) optimal prevention and treatment strategies. The workshop was sponsored by the Office of Disease Prevention and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. A multidisciplinary steering committee developed the workshop agenda. The NIH Library created an extensive, descriptive bibliography on PCOS to facilitate workshop discussion. During the 2½-day workshop, invited experts discussed the body of evidence and attendees provided comments during open discussion periods. After weighing the evidence, an unbiased, independent panel prepared a report that summarized the workshop and identified future research priorities. The workshop was held on December 3-5, 2012.
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