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2024-2028 NIH-Wide Strategic Plan on Research on the Health of Women
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Other
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AHRQ, CDC, FDA, HRSA, OASH
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CSR, FIC, NCATS, NCCIH, NCI, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NIMHD, NINDS, NINR, NLM, OD/All of Us, OD/DPCPSI/OAR, OD/DPCPSI/OBSSR, OD/DPCPSI/ODS, OD/DPCPSI/ODSS, OD/DPCPSI/OEPR, OD/DPCPSI/ONR, OD/DPCPSI/ORWH, OD/DPCPSI/SGMRO
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ORWH is responsible for an NIH-wide strategic plan on research on the health of women that promotes allocation of NIH resources for conducting and supporting research efforts on the health of women across NIH Institutes and Centers. ORWH is currently undergoing the process of updating the NIH-Wide Strategic Plan for Research on the Health of Women. Recent, significant public health events (e.g., the COVID pandemic) have had an outsized effect on the health of women. Several topics relevant to the health of women were reviewed by the NIH and the NIH Advisory Committee on Research on Women’s Health (ACRWH) in 2021, through the congressionally-directed and ORWH-led Women’s Health Conference. This convening included a review of NIH activities to identify research opportunities to address maternal mortality and morbidity, survival rates of cervical cancer, and chronic and debilitating diseases in women. The recommendations that the ACRWH made consequent to this conference as well as recent scientific advances; new technologies; current health priorities; and feedback from a Request for Information will all be considered in the development of the next NIH-Wide Strategic Plan for Research on the Health of Women to help guide future NIH research efforts to improve the health of all women throughout the entire life course. NIH published a Notice (NOT-OD-22-186) to solicit input from the basic, clinical, and translational scientists; advocacy and patient communities; and the public on topics under consideration for the next strategic plan. ORWH established NIH, HHS, and VA engagement in the development of the 2024-2028 NIH-Wide Strategic Plan on Research on the Health of Women that will be released in 2024.
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21st Centruy Cures Act Working Group
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Committee, Work group, Advisory group, or Task Force
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FDA
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OD/OER
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Federal subject matter experts carried out a review to identify inconsistent, overlapping, and unnecessarily duplicative regulations and policies and prepared a report of recommendations to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals. Implementation and evaluation is ongoing.
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21st Century Cures Implementation and Harmonization
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Committee, Work group, Advisory group, or Task Force
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FDA
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OD/OER
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Interagency meetings are held twice a year to review implementation of the 21st Century Cures Act Working Group recommendations and discuss ways to harmonize and continue burden reduction efforts
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A nested case-control study of circulating per- and polyfluoroalkyl substances (PFAS) and uterine and ovarian cancers
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Research Initiative
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CDC
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NCI
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National Cancer Institute (NCI) and Centers for Disease Control and Prevention (CDC) are collaborating to measure serum levels of per- and polyfluoroalkyl substances (PFAS) for nested case-control studies of endometrial (uterine) and ovarian cancers in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial.
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A nested case-control study of serum PFAS and testicular cancer in military servicemen
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Research Initiative
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CDC
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NCI
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National Cancer Institute (NCI) is collaborating with Uniformed Services University of the Health Sciences (USUHS) and Centers for Disease Control and Prevention (CDC) on a nested case-control study measuring serum PFAS concentrations among military servicemen with samples in the Department of Defense Serum Repository. An initial study, focused on Air Force personnel, was completed. A follow-up study, involving personnel from other service branches, is underway.
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A Study of Markers of Cosmic Radiation Exposure and Effect Among Flight Crews
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Research Initiative
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CDC
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NCI
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NCI and CDC are collaborating on a cross-sectional study of 83 airline pilots and 50 university faculty to assess the relation of stable chromosome translocations with cosmic radiation exposure.
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A5418: Study of Tecovirimat For Human Pox Virus
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Other
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CDC, FDA
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NIAID
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To see if tecovirimat is safe, and whether it helps treat pox infection.
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Accelerating COVID-19 Therapeutic Interventions and Vaccines-6: Outpatient Repurposed Drugs (ACTIV-6)
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Research Initiative
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ASPR, CDC, FDA
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NCATS, NHLBI, NIAID
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The ACTIV public-private partnership has evaluated hundreds of available therapeutic agents with potential application for COVID-19, prioritized the most promising candidates, designed and harmonized adaptive master protocols for ACTIV clinical trials, and selected numerous NIH-supported networks to launch these clinical trials to test prioritized therapeutic candidates. ACTIV-6 is designed to test the effectiveness of repurposed drugs (drugs that are FDA-approved for non-COVID-19 indications and have known safety profiles) in reducing the duration and severity of symptoms associated with mild-to-moderate COVID-19. The large, randomized, placebo-controlled Phase 3 trial enrolled outpatient participants who are at least 30 years old, tested positive for SARS-CoV-2 infection and showed two or more mild-to-moderate symptoms of COVID-19 for no more than seven days. Results for ivermectin, fluvoxamine, fluticasone and montelukast are available on medRxiv. Results for ivermectin and fluvoxamine have been published in JAMA. Results for fluticasone have been published in the New England Journal of Medicine. Testing of metformin is ongoing.
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Accelerating Medicines Partnership® Schizophrenia
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Research Initiative
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FDA
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NIMH
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The Foundation for the National Institutes of Health (FNIH), together with National Institute of Mental Health (NIMH) and public and private partners, is leading the Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ) as the first neuropsychiatric project within the AMP program. The public-private partnership will tackle the critical need for more effective treatments for people with schizophrenia.
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AccessGUDID
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Resource Development
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FDA
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NLM
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The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI). The National Library of Medicine (NLM), in collaboration with the FDA, created the AccessGUDID portal to make device identification information in the GUDID available for everyone, including patients, caregivers, healthcare providers, hospitals, and industry. NLM provides technical and customer support for the system. As enhancements and changes are made to the system, NLM and FDA work collaboratively to provide user support and training. https://accessgudid.nlm.nih.gov
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