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Abuse Liability Evaluation for Research, Treatment, and Training (ALERTT)
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Research Initiative
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FDA
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NIDA
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Abuse Liability Evaluation for Research, Treatment, and Training (ALERTT) is part of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the US Food and Drug Administration (FDA). The mission of the (ACTTION) is to identify, prioritize, sponsor, coordinate, and promote innovative activities with a special interest in optimizing clinical trials that will expedite the discovery and development of improved analgesic, anesthetic, and addiction treatments for the benefit of public health.
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Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Therapeutics Working Group
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA, ASPR
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NIAID
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Develop master protocols to support the ACTIV Research; Prioritize putative therapeutics candidates for entry into trials
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Accelerating COVID-19 Therapeutic Interventions and Vaccines-1: Immune Modulators (ACTIV-1)
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Research Initiative
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FDA, ASPR
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NCATS
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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. The ACTIV-1 master protocol is testing promising immune modulator compounds, a class of drugs that help minimize the deleterious effects of an overactive immune response to SARS-CoV-2 infection. This Phase 3 trial enrolled hospitalized adults with moderate to severe COVID-19 disease. The goal of the trial is to evaluate the safety and efficacy of each immune modulator when given as an add-on therapy to standard of care (SOC) at local clinics, which may include remdesivir (provided as part of the study to all participants), an antiviral approved for treatment of COVID-19The different treatments will be assessed with respect to illness severity, recovery speed, mortality, and hospital resource utilization.
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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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CDC, FDA, ASPR
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NCATS, NIAID, NHLBI
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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 will enroll outpatient participants who are at least 30 years old, have tested positive for SARS-CoV-2 infection and show two or more mild-to-moderate symptoms of COVID-19 for no more than seven days. ;Drugs that demonstrate efficacy in reducing symptoms of mild-to-moderate COVID-19 will be further evaluated for effects on clinical outcomes (hospitalization, mortality) and long-term COVID-19 symptoms.;
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Accelerating Implementation of Cancer Control Programs in APEC Economies through Innovation and Partnership
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Committee, Work group, Advisory group, or Task Force
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OGA
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NCI
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This APEC project aimed to advance a coordinated approach to cancer control policy within the Asia-Pacific and develop a harmonized, strategic roadmap for robust implementation. This project comprised four Thematic Sessions on: (a) cancer prevention; (b) screening and early detection; (c) improving access for cancer treatment and management; and (d) implementation, governance, ; evaluation of cancer control programs, and was held from September 2021 through January 2022. The workshops were led by the Health Promotion Administration, MoHW of Chinese Taipei, and were facilitated by the APEC Life Sciences Innovation Forum. As co-sponsor of this project, the US supported this effort. CGH worked together with the APEC Life Sciences Innovation Forum, and advised on technical content, facilitated speaker and participant selection, and reviewed preliminary reports.
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Accelerating Medicines Partnership (AMP)
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Other
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FDA
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OD/OSP, NIA, NIDDK, NIAMS, NINDS, NIMH
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Public-private partnership between the National Institutes of Health (NIH), the Food and Drug Administration (FDA), multiple biopharmaceutical companies and multiple non-profit organizations, and managed by the Foundation for NIH (FNIH), to transform the current model for developing new diagnostics and treatments by jointly identifying and validating promising biological targets for therapeutics.
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Accelerating Medicines Partnership Schizophrenia (AMP SCZ)
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Research Initiative
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FDA
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NIMH
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Substance Abuse and Mental Health Services Administration (SAMHSA) convened a technical expert panel to provide guidance on the development of an evidence-based practice guide on the treatment of serious mental illness in older adults. The guide is an important part of the 21st Century Cures Act's charge at SAMHSA to disseminate information on evidence-based practices and will address best practices for older adults.
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AccessGUDID
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Resource Development
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FDA, GDM
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NLM
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The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the Food and Drug Administration (FDA) about medical devices that have Unique Device Identifiers (UDI). The National Library of Medicine (NLM), in collaboration with the FDA, has created the AccessGUDID portal to make device identification information in the GUDID available for everyone, including patients, caregivers, healthcare providers, hospitals, and industry.
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ACL Advisory Council on Grandparents Raising Grandchildren
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Committee, Work group, Advisory group, or Task Force
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ACL, ACF, SAMHSA, CDC, HRSA, ASPE, ONC
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NIA
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The mission of the Advisory Council to Support Grandparents Raising Grandchildren (SGRG) is to identify, promote, coordinate and disseminate information, resources, and best practices to help grandparents and older relative caregivers of children meet the health, educational, nutritional, and other needs of the children in their care, while maintaining their own physical, mental, and emotional well-being. As part of this vision, all recommendations will consider the needs of members of Native American tribes and families affected by the opioid crisis.
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Action for Health in Diabetes Extension (Look AHEAD-E)
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Research Initiative
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CDC, IHS
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NIDDK, NIA, OD/DPCPSI/ORWH
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The Action for Health in Diabetes (Look AHEAD) is a randomized trial comparing the effects of Intensive Lifestyle Intervention (ILI) focused on weight loss achieved through healthy eating and increased physical activity versus a control condition of Diabetes Support and Education (DSE) in overweight and obese individuals with type 2 diabetes. The Look AHEAD Extension (Look AHEAD-E) will examine whether ILI, provided for 10 years during mid-life, has enduring benefits that persist beyond the period of the intervention for older individuals with diabetes.
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