| Circulating Estrogens, Androgens, and Progestogens and Risk of Breast Cancer in the PLCO Cohort |
Research Initiative |
CDC |
NCI |
In a stratified cohort study of breast cancer in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO), restricted to postmenopausal women not on menopausal hormone therapy, we are using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay recently developed by CDC to assess prediagnostic circulating levels of the endogenous steroid hormones believed to be involved in breast cancer etiology. Although it is known that endogenous hormones play a critical role in the etiology of breast cancer, the interrelationships among estrogens, androgens, and progesterone in determining risk are not well understood. |
| CISA: Clinical Immunization Safety Assessment Network |
Committee, Work group, Advisory group, or Task Force |
CDC |
NHLBI, NIAID |
DAIT leadership and Allergy, Asthma and Airway Biology Branch personnel discussing with CDC findings from a recent CDC-funded study suggetive of an association between the amount of aluminum in infant vaccines and the incidence of asthma |
| ClinGen-FDA Recognized Human Variant Database |
Resource Development |
FDA |
NCI, NEI, NHGRI, NICHD, NINDS |
In April 2018, the FDA announced the initiation of a Public Human Genetic Variant Database program to support the agency’s precision medicine initiatives. A primary aim of the program is to foster innovation among test developers and advances in patient care through access to valid sources of accurate human variant interpretation data. Data and assertions within the database are considered to be valid scientific evidence that can be used to streamline the test development and validation processes. The NIH-funded Clinical Genome Resource (ClinGen) become the first FDA recognized database with a scope focused on germline variants in hereditary disease with a high likelihood the condition will manifest. ClinGen is currently working with the FDA to maintain this recognition. |
| Clinical and Translational Serology Task Force |
Resource Development |
ASPR, CDC, FDA |
NCI, NIAID |
The National Cancer Institute established a taskforce to catalyze translation of research findings into public health changes. The task force brings together government, academia and industry to provide relevant tools and information related to serology testing to help decisionmakers manage the current and future status of the SARS-CoV-2 pandemic. The task force includes scientists from several disciplines, clinicians, regulatory and public policy experts, and patient advocates. |
| Clinical Research Using Medicare Data from the Virtual Research Data Center (VRDC) |
Research Initiative |
CMS |
NLM |
The National Library of Medicine (NLM) and other Institutes and Centers at NIH work with the Centers for Medicare & Medicaid Services (CMS) to demonstrate the value of the CMS Virtual Research Data Center (VRDC) as a data source for research. NLM's health information standards and discovery research leverage the VRDC to answer important epidemiologic and clinical questions, particularly regarding drug benefits and possible harms. https://resdac.org/ |
| Clinical Trials Innovation Unit |
Other |
FDA |
NCI |
The NCI Clinical Trials Innovation Unit (CTIU) was launched in February 2023 to advance innovative science, trial designs, and operational efficiencies for high-priority clinical research needs. It includes experts from NCI, the Food and Drug Administration (FDA), and the extramural cancer clinical research community. |
| Clinical Trials of Biodefense Vaccines (Dengue) |
Research Initiative |
CDC |
NIAID |
Clinical Trials of Biodefense Vaccines (Dengue) |
| Clinical Trials Transformation Initiative |
Committee, Work group, Advisory group, or Task Force |
FDA |
NIAID |
Working group developing a pandemic preparedness clinical trial framework. |
| Clinical Vocabulary and Standards Development for Meaningful Use of Electronic Medical Records |
Resource Development |
OS, CDC, CMS, FDA, ONC |
NLM |
The National Library of Medicine (NLM) collaborates with the HHS Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) to develop, maintain, and disseminate clinical terminologies and codes related to health information technology, electronic health records, and messaging. http://www.nlm.nih.gov/healthit.html |
| CMS Alliance to Modernize Healthcare Federally Funded Research & DevelopmentCenter (Health FFRDC) |
Committee, Work group, Advisory group, or Task Force |
CMS, ACF, AHRQ, ASA, ASFR, ASPE, ASPR, CDC, CMS, FDA, HRSA, IHS, OASH, OCIIO, OGA, OIG, ONC, OS, SAMHSA |
CC, NCATS, NCI, NHLBI, NIA, NIAID, NLM |
As a Federally Funded Research and Development Center (FFRDC), the Alliance To Modernize Healthcare a.k.a. "Health FFRDC" provides unique access to unbiased strategic insights, analyses, and best practices to accelerate and optimize business transformation. Formally established under Federal Acquisition Regulation (FAR) Part 35.017, FFRDCs meet special, long-term research and development needs integral to the mission of the sponsoring agency. FFRDCs operate in the public interest, free from conflicts of interest, and are managed and/or administered by not-for-profit organizations, universities, or industrial firms as separate operating units.More information at https://www.cms.gov/data-research/research/alliance-modernize-healthcar… |