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ISPOR
ISPOR—The Professional Society for Health Economics and Outcomes Research, better known as ISPOR (formerly, the International Society for Pharmacoeconomics and Outcomes Research), is a nonprofit global professional organization in health economics and outcomes research. It was founded in 1995 as an international multidisciplinary professional organization that advances the policy, science, and practice of pharmacoeconomics (health economics) and outcomes research (the scientific discipline that evaluates the effect of healthcare interventions on patient well-being including clinical, economic, and patient-centered outcomes). The society's mission is to promote health economics and outcomes research to improve decision making for health globally. As of January 2022, the society has 14,000 individual and chapter members from more than countries with a majority in North America (41%) followed by Europe (37%), Asia Pacific (11%), Latin America (5%), Africa & Oceania (4%), and Middle ...
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Edwards Lifesciences
Edwards Lifesciences is an American medical technology company headquartered in Irvine, California, specializing in artificial heart valves and hemodynamic monitoring. It developed the SAPIEN transcatheter aortic heart valve made of cow tissue within a balloon-expandable, cobalt-chromium frame, deployed via catheter. The company has manufacturing facilities at the Irvine headquarters, as well as in Draper, Utah; Costa Rica; the Dominican Republic; Puerto Rico; and Singapore; and is building a new facility due to be completed in 2021 in Limerick, Ireland. History Edwards was originally founded by engineer Miles “Lowell” Edwards in 1958. Edwards and Dr. Albert Starr, a surgeon at the University of Oregon Medical School, designed, developed, tested and successfully placed in a patient the first Starr-Edwards mitral valve in 1960. As a result of the successful heart surgery, Edwards Laboratories was founded in Santa Ana, California that same year. Edwards was acquired by Baxter ...
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Value In Health
''Value in Health'' is a medical journal that covers original research and health policy articles in the field of health economics and outcomes research. The journal is published, on the behalf of ISPOR, by Elsevier Elsevier () is a Dutch academic publishing company specializing in scientific, technical, and medical content. Its products include journals such as ''The Lancet'', ''Cell'', the ScienceDirect collection of electronic journals, '' Trends'', th .... Abstracting and indexing The journal is abstracted and indexed in: * Current Contents - Social & Behavioral Sciences * Embase * PubMed/Medline * International Pharmaceutical Abstracts * Journal Citation Reports - Science Edition * Social Sciences Citation Index * PubMed/Medline References External links * Elsevier academic journals English-language journals Publications with year of establishment missing Healthcare journals {{med-journal-stub ...
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Pharmacoeconomics
Pharmacoeconomics refers to the scientific discipline that compares the value of one pharmaceutical drug or drug therapy to another. It is a sub-discipline of health economics. A pharmacoeconomic study evaluates the cost (expressed in monetary terms) and effects (expressed in terms of monetary value, efficacy or enhanced quality of life) of a pharmaceutical product. Pharmacoeconomic studies serve to guide optimal healthcare resource allocation, in a standardized and scientifically grounded manner. Economic evaluation Pharmacoeconomics centers on the economic evaluation of pharmaceuticals, and can use cost-minimization analysis, cost-benefit analysis, cost-effectiveness analysis or cost-utility analysis. Quality-adjusted life years have become the dominant outcome of interest in pharmacoeconomic evaluations, and many studies employ a cost-per-QALY analysis. Economic evaluations are carried out alongside randomized controlled trials and using methods of decision-analytic modelin ...
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International Society For Pharmacoepidemiology
The International Society for Pharmacoepidemiology (ISPE) is a society focused on the practice of pharmacoepidemiology. The society was launched officially by Stanley A. Edlavitch, David E. Lilienfeld, and Hugh A. Tilson in 1989 during the Fifth International Conference on Pharmacoepidemiology (ICPE) in Minneapolis. ISPE is the only international acting society dealing with the topics of pharmacoepidemiology in the context of pharmacovigilance or drug safety; the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) addresses outcomes research epidemiology. The society has organized yearly conferences since its foundation. The society's office is located in Bethesda, Maryland, and its executive secretary is James Vrac. A number of the major figures in drug safety and pharmacovigilance have served as its Presidents, and its Officers and Trustees have been drawn from the leadership of the pharmacoepidemiology community. Members of the Society come from 53 nations ...
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Real World Evidence
Real-world evidence (RWE) in medicine is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data (RWD). RWE can be generated by different study designs or analyses, including but not limited to, randomized trials, including large simple trials, pragmatic trials, and retrospective or prospective observational studies. In the USA the 21st Century Cures Act required the FDA to expand the role of real world evidence. Real-world evidence comes into play when clinical trials cannot really account for the entire patient population of a particular disease. Patients with comorbidities or belonging to a distant geographic region or age limit who did not participate in any clinical trial may not respond to the treatment in question as expected. RWE provides answers to these problems and also to analyze effects of drugs over a longer period of time. Pharmaceutical companies and health insurance payers study RWE ...
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Pharmacoeconomics
Pharmacoeconomics refers to the scientific discipline that compares the value of one pharmaceutical drug or drug therapy to another. It is a sub-discipline of health economics. A pharmacoeconomic study evaluates the cost (expressed in monetary terms) and effects (expressed in terms of monetary value, efficacy or enhanced quality of life) of a pharmaceutical product. Pharmacoeconomic studies serve to guide optimal healthcare resource allocation, in a standardized and scientifically grounded manner. Economic evaluation Pharmacoeconomics centers on the economic evaluation of pharmaceuticals, and can use cost-minimization analysis, cost-benefit analysis, cost-effectiveness analysis or cost-utility analysis. Quality-adjusted life years have become the dominant outcome of interest in pharmacoeconomic evaluations, and many studies employ a cost-per-QALY analysis. Economic evaluations are carried out alongside randomized controlled trials and using methods of decision-analytic modelin ...
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Cost-effectiveness Analysis
Cost-effectiveness analysis (CEA) is a form of economic analysis that compares the relative costs and outcomes (effects) of different courses of action. Cost-effectiveness analysis is distinct from cost–benefit analysis, which assigns a monetary value to the measure of effect. Cost-effectiveness analysis is often used in the field of health services, where it may be inappropriate to monetize health effect. Typically the CEA is expressed in terms of a ratio where the denominator is a gain in health from a measure (years of life, premature births averted, sight-years gained) and the numerator is the cost associated with the health gain. The most commonly used outcome measure is quality-adjusted life years (QALY). Cost–utility analysis is similar to cost-effectiveness analysis. Cost-effectiveness analyses are often visualized on a plane consisting of four quadrants, the cost represented on one axis and the effectiveness on the other axis. Cost-effectiveness analysis focuses on m ...
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Breast Cancer
Breast cancer is cancer that develops from breast tissue. Signs of breast cancer may include a lump in the breast, a change in breast shape, dimpling of the skin, milk rejection, fluid coming from the nipple, a newly inverted nipple, or a red or scaly patch of skin. In those with distant spread of the disease, there may be bone pain, swollen lymph nodes, shortness of breath, or yellow skin. Risk factors for developing breast cancer include obesity, a lack of physical exercise, alcoholism, hormone replacement therapy during menopause, ionizing radiation, an early age at first menstruation, having children late in life or not at all, older age, having a prior history of breast cancer, and a family history of breast cancer. About 5–10% of cases are the result of a genetic predisposition inherited from a person's parents, including BRCA1 and BRCA2 among others. Breast cancer most commonly develops in cells from the lining of milk ducts and the lobules that supply these ...
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Medical Device
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase. Discovery of what would be considered a medical device by modern standards dates as far back as c. 7000 BC in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it wasn't until the Federal Food, Drug, and Cosmetic Act (F ...
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Federal Food, Drug, And Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations. The introduction of this act was influenced by the death of more than 100 patients due to elixir sulfanilamide, a sulfanilamide medication where the toxic solvent diethylene glycol was us ...
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21st Century Cures Act
The 21st Century Cures Act is a United States law enacted by the 114th United States Congress in December 2016 and then signed into law on December 13, 2016. It authorized $6.3 billion in funding, mostly for the National Institutes of Health. The act was supported especially by large pharmaceutical manufacturers and was opposed especially by some consumer organizations. Proponents said that it would streamline the drug and device approval process and bring treatments to market faster. Opponents said that it would allow drugs and devices to be approved on weaker evidence, bypassing randomized, controlled trials, and bring more dangerous or ineffective treatments to market. The bill incorporated the Helping Families In Mental Health Crisis Act, first introduced by then-Congressman Tim Murphy, R-Pa., which increased the availability of psychiatric hospital beds and established a new assistant secretary for mental health and substance use disorders. Content Research and drug de ...
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American Society Of Clinical Oncology
The American Society of Clinical Oncology (ASCO) is a professional organization representing physicians of all oncology sub-specialties who care for people with cancer. Founded in 1964 by Fred Ansfield, Harry Bisel, Herman Freckman, Arnoldus Goudsmit, Robert Talley, William Wilson, and Jane C. Wright, it has nearly 45,000 members worldwide. Physician education ASCO offers educational resources for cancer physicians and other health care professionals of clinical oncology. These include scientific meetings, educational conferences, professional workshops, and special symposia on issues of particular relevance and importance to oncologists and researchers. It also produced the patient information website, Cancer.Net. It publishes numerous journals, books, newsletters, and online and multimedia resources; it publishes the ''Journal of Clinical Oncology The ''Journal of Clinical Oncology'' is a peer-reviewed medical journal published 3 times a month by the Lippincott Williams ...
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