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Imaging Biomarker
An imaging biomarker is a biologic feature, or biomarker detectable in an image. In medicine, an imaging biomarker is a feature of an image relevant to a patient's diagnosis. For example, a number of biomarkers are frequently used to determine risk of lung cancer. First, a simple lesion in the lung detected by X-ray, CT, or MRI can lead to the suspicion of a neoplasm. The lesion itself serves as a biomarker, but the minute details of the lesion serve as biomarkers as well, and can collectively be used to assess the risk of neoplasm. Some of the imaging biomarkers used in lung nodule assessment include size, spiculation, calcification, cavitation, location within the lung, rate of growth, and rate of metabolism. Each piece of information from the image represents a probability. Spiculation increases the probability of the lesion being cancer. A slow rate of growth indicates benignity. These variables can be added to the patient's history, physical exam, laboratory tests, and patholo ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biomarker
In biomedical contexts, a biomarker, or biological marker, is a measurable indicator of some biological state or condition. Biomarkers are often measured and evaluated using blood, urine, or soft tissues to examine normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. as cited in Biomarkers are used in many scientific fields. Medicine Biomarkers used in the medical field, are a part of a relatively new clinical toolset categorized by their clinical applications. The three main classes are molecular biomarkers, cellular biomarkers or imaging biomarkers. All three types of biomarkers have a clinical role in narrowing or guiding treatment decisions and follow a sub-categorization of being either predictive, prognostic, or diagnostic. Predictive Predictive molecular, cellular, or imaging biomarkers that pass validation can serve as a method of predicting clinical outcomes. Predictive biomarkers are used to help optimize ide ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Endpoint
Clinical endpoints or clinical outcomes are outcome measures referring to occurrence of disease, symptom, sign or laboratory abnormality constituting a target outcome in clinical research trials. The term may also refer to any disease or sign that strongly motivates withdrawal of an individual or entity from the trial, then often termed a ''humane (clinical) endpoint''. The primary endpoint of a clinical trial is the endpoint for which the trial is powered. Secondary endpoints are additional endpoints, preferably also pre-specified, for which the trial may not be powered. Surrogate endpoints are trial endpoints that have outcomes that substitute for a clinical endpoint, often because studying the clinical endpoint is difficult, for example using an increase in blood pressure as a surrogate for death by cardiovascular disease, where strong evidence of a causal link exists. Scope In a general sense, a clinical endpoint is included in the entities of interest in a trial. The res ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Leland Hartwell
Leland Harrison (Lee) Hartwell (born October 30, 1939 in Los Angeles, California) is former president and director of the Fred Hutchinson Cancer Research Center in Seattle, Washington. He shared the 2001 Nobel Prize in Physiology or Medicine with Paul Nurse and Tim Hunt, for their discoveries of protein molecules that control the division (duplication) of cells. Working in yeast, Hartwell identified the fundamental role of checkpoints in cell cycle control, and CDC genes such as CDC28, which controls the start of the cycle—the progression through G1. Education Hartwell attended Glendale High School in Glendale, California, and then received his Bachelor of Science from the California Institute of Technology in 1961. In 1964, he received his Doctor of Philosophy in biology from the Massachusetts Institute of Technology. From 1965 to 1968, he worked at the University of California, Irvine as a professor. He moved to the University of Washington in 1968. In a series of experimen ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Massachusetts General Hospital
Massachusetts General Hospital (Mass General or MGH) is the original and largest teaching hospital of Harvard Medical School located in the West End neighborhood of Boston, Massachusetts. It is the third oldest general hospital in the United States and has a capacity of 999 beds. With Brigham and Women's Hospital, it is one of the two founding members of Mass General Brigham (formerly known as Partners HealthCare), the largest healthcare provider in Massachusetts. Massachusetts General Hospital houses the largest hospital-based research program in the world, the Mass General Research Institute, with an annual research budget of more than $1 billion in 2019. It is currently ranked as the #8 best hospital in the United States by '' U.S. News & World Report''. In , ''The Boston Globe'' ranked MGH the fifth best place to work out of Massachusetts companies with over 1,000 employees. History Founded in 1811, the original hospital was designed by the famous American architect Charle ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Critical Path Institute
Critical Path Institute (C-Path) is a non-profit organization created to improve the drug development process; its consortia include more than 1,600 scientists from government regulatory and research agencies, academia, patient organizations, and bio-pharmaceutical companies. Background The U.S. Food and Drug Administration (FDA) launched the Critical Path Initiative in 2004 to transform the way FDA-regulated medical products are developed, evaluated, and manufactured. C-Path was created as an independent organization to respond to the needs outlined in the FDA's initiative and with support and funding from the FDAScience Foundation Arizona and the Tucson, Arizona community. It operates as a neutral third party to enable scientists from the regulated industry and international regulatory agencies to work together with scientists from academia and patient groups to improve the drug development process. Approach In the interest of national and global public health, C-Path develops ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmaceutical Research And Manufacturers Of America
Pharmaceutical Research and Manufacturers of America (PhRMA, pronounced ), formerly known as the Pharmaceutical Manufacturers Association, is a trade group representing companies in the pharmaceutical industry in the United States. Founded in 1958, PhRMA lobbies on behalf of pharmaceutical companies. PhRMA is headquartered in Washington, DC. The organization has lobbied fiercely against allowing Medicare to negotiate drug prices for Medicare recipients. At the state level, the organization has lobbied to prevent price limits and greater price transparency for drugs. PhRMA has given substantial dark money donations to right-wing advocacy groups such as the American Action Network (which lobbied heavily against the Affordable Care Act), the Koch brothers' Americans for Prosperity and Grover Norquist's Americans for Tax Reform, while rarely providing some donations to centrist or moderately right-leaning groups such as Center Forward. Membership Leadership George A. Scango ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
National Institute Of Health
The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late 1880s and is now part of the United States Department of Health and Human Services. The majority of NIH facilities are located in Bethesda, Maryland, and other nearby suburbs of the Washington metropolitan area, with other primary facilities in the Research Triangle Park in North Carolina and smaller satellite facilities located around the United States. The NIH conducts its own scientific research through the NIH Intramural Research Program (IRP) and provides major biomedical research funding to non-NIH research facilities through its Extramural Research Program. , the IRP had 1,200 principal investigators and more than 4,000 postdoctoral fellows in basic, translational, and clinical research, being the largest biomedical research institu ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Foundation For The National Institutes Of Health
The Foundation for the National Institutes of Health (FNIH) is a not-for-profit, 501(c)(3) charitable organization established by the US Congress in 1990. Located in North Bethesda, MD, the FNIH raises private-sector funds, and creates and manages alliances with public and private institutions in support of the mission of the National Institutes of Health (NIH). Research programs The FNIH collaborates on biomedical research programs to advance breakthrough scientific discoveries. Research partnerships include: * Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV): a public–private partnership led by the National Institutes of Health (NIH) and coordinated by the Foundation for the National Institutes of Health (FNIH) to develop a research strategy for prioritizing and speeding development of the most promising COVID-19 vaccines and COVID-19 treatments. ACTIV brings together NIH with the United States Department of Health and Human Services agencies, includin ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Phase III Trials
The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases start with testing for safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays. Summary Clinical trials testing potential medical products are commonly classified into four phases. The drug development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV trials are 'post-marketing' or 'surveillance' studies conducted to monitor safety over severa ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trials
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Surrogate Endpoint
In clinical trials, a surrogate endpoint (or surrogate marker) is a measure of effect of a specific treatment that may correlate with a ''real'' clinical endpoint but does not necessarily have a guaranteed relationship. The National Institutes of Health (USA) defines surrogate endpoint as "a biomarker intended to substitute for a clinical endpoint". Surrogate markers are used when the primary endpoint is undesired (e.g., death), or when the number of events is very small, thus making it impractical to conduct a clinical trial to gather a statistically significant number of endpoints. The FDA and other regulatory agencies will often accept evidence from clinical trials that show a direct clinical benefit to surrogate markers. Surrogate endpoints can be obtained from different modalities, such as, behavioural or cognitive scores, or biomarkers from Electroencephalography ( qEEG), MRI, PET, or biochemical biomarkers. A correlate does not make a surrogate. It is a common misconce ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs, but involves such things as regulating lasers, cellular phones, and condoms, as well as control of disease in contexts v ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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