| 2024-2028 NIH-Wide Strategic Plan on Research on the Health of Women |
Other |
AHRQ, CDC, FDA, HRSA, OASH |
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 |
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. Recommendations made by the NIH Advisory Committee on Research on Women’s Health (ACRWH), NIH scientists and researchers, as well as recent scientific advances; new technologies; current health priorities; and feedback from a Request for Information were all considered in the development of the strategic plan to help guide future NIH research efforts to improve the health of all women throughout the entire life course. ORWH also ensured that HHS and VA were engaged in the development of the 2024-2028 NIH-Wide Strategic Plan on Research on the Health of Women, published in 2024. |
| 21st Century Cures Act Working Group |
Committee, Work group, Advisory group, or Task Force |
FDA |
OD/OER |
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. |
| 21st Century Cures Implementation and Harmonization |
Committee, Work group, Advisory group, or Task Force |
FDA |
OD/OER |
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 |
| A nested case-control study of circulating per- and polyfluoroalkyl substances (PFAS) and uterine and ovarian cancers |
Research Initiative |
CDC |
NCI |
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. |
| A nested case-control study of serum PFAS and testicular cancer in military servicemen |
Research Initiative |
CDC |
NCI |
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. |
| A Study of Markers of Cosmic Radiation Exposure and Effect Among Flight Crews |
Research Initiative |
CDC |
NCI |
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. |
| A5418: Study of Tecovirimat for Human MPox Virus |
Other |
ASPR, CDC, FDA |
NIAID |
A5418 (STOMP) is a study of tecovirimat (also known as TPOXX) for the treatment of human monkeypox virus (HMPXV) disease. |
| Accelerating COVID-19 Therapeutic Interventions and Vaccines-6: Outpatient Repurposed Drugs (ACTIV-6) |
Research Initiative |
ASPR, CDC, FDA |
NCATS, NHLBI, NIAID |
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, montelukast, and metformin are available on medRxiv. Results for ivermectin and fluvoxamine have been published in JAMA. Results for montelukast were published in JAMA Network Open, and fluticasone results were published in the New England Journal of Medicine. |
| Accelerating Medicines Partnership® (AMP®) Autoimmune & Immune Mediated Diseases Program |
Research Initiative |
FDA |
NEI, NIAID, NIAMS, NIDCR, OD/DPCPSI/ORWH |
The National Eye Institute (NEI) is one of 5 NIH Institutes and Centers (ICs) that have partnered with the FDA, FNIH, pharmaceutical companies, and nonprofit organizations to create the Accelerating Medicines Partnership® (AMP®) Autoimmune & Immune Mediated Diseases Program (AMP AIM). The goals of the AIM are to dissect mechanisms of disease at the cellular level in affected tissues and blood in rheumatoid arthritis, lupus, Sjögren’s disease, and psoriatic spectrum diseases; create a spatial map of key molecular and cellular types and states to identify the pathways of crosstalk between cells that drive inflammation, abnormal immune function, and damage; compare mechanisms of autoimmune and immune-mediated diseases across tissues to facilitate the identification of shared and independent druggable pathways and targets and to create a dedicated Knowledge Portal to host clinical, cellular, and molecular datasets, standardized methods, and computational tools to allow rapid and efficient data sharing and interrogation by the research community. |
| Accelerating Medicines Partnership® Amyotrophic Lateral Sclerosis (ALS) |
Resource Development |
FDA |
NINDS |
AMP ALS aims to promote development of novel therapies for ALS, including by generating a comprehensive, centralized ALS dataset to facilitate ALS biomarker validation. |