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Clinical Study Design
Clinical study design is the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research (e.g., epidemiological) involving human beings. The goal of a clinical study is to assess the safety, efficacy, and / or the mechanism of action of an investigational medicinal product (IMP) or procedure, or new drug or device that is in development, but potentially not yet approved by a health authority (e.g. Food and Drug Administration). It can also be to investigate a drug, device or procedure that has already been approved but is still in need of further investigation, typically with respect to long-term effects or cost-effectiveness. Some of the considerations here are shared under the more general topic of design of experiments but there can be others, in particular related to patient confidentiality and ethics. Outline of types of designs for clinical studies Treatment studies * Randomized controlled trial ** Blind trial ** ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trial
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] |
Time Series
In mathematics, a time series is a series of data points indexed (or listed or graphed) in time order. Most commonly, a time series is a sequence taken at successive equally spaced points in time. Thus it is a sequence of discrete-time data. Examples of time series are heights of ocean tides, counts of sunspots, and the daily closing value of the Dow Jones Industrial Average. A time series is very frequently plotted via a run chart (which is a temporal line chart). Time series are used in statistics, signal processing, pattern recognition, econometrics, mathematical finance, weather forecasting, earthquake prediction, electroencephalography, control engineering, astronomy, communications engineering, and largely in any domain of applied science and engineering which involves temporal measurements. Time series ''analysis'' comprises methods for analyzing time series data in order to extract meaningful statistics and other characteristics of the data. Time series ''forecasting' ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Longitudinal Study
A longitudinal study (or longitudinal survey, or panel study) is a research design that involves repeated observations of the same variables (e.g., people) over short or long periods of time (i.e., uses longitudinal data). It is often a type of observational study, although it can also be structured as longitudinal randomized experiment. Longitudinal studies are often used in social-personality and clinical psychology, to study rapid fluctuations in behaviors, thoughts, and emotions from moment to moment or day to day; in developmental psychology, to study developmental trends across the life span; and in sociology, to study life events throughout lifetimes or generations; and in consumer research and political polling to study consumer trends. The reason for this is that, unlike cross-sectional studies, in which different individuals with the same characteristics are compared, longitudinal studies track the same people, and so the differences observed in those people are less like ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Crossover Study
In medicine, a crossover study or crossover trial is a longitudinal study in which subjects receive a sequence of different treatments (or exposures). While crossover studies can be observational studies, many important crossover studies are controlled experiments, which are discussed in this article. Crossover designs are common for experiments in many scientific disciplines, for example psychology, pharmaceutical science, and medicine. Randomized, controlled crossover experiments are especially important in health care. In a randomized clinical trial, the subjects are randomly assigned to different arms of the study which receive different treatments. When the trial has a repeated measures design, the same measures are collected multiple times for each subject. A crossover trial has a repeated measures design in which each patient is assigned to a sequence of two or more treatments, of which one may be a standard treatment or a placebo. Nearly all crossover are designed to ha ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Standard Of Care
In tort law, the standard of care is the only degree of prudence and caution required of an individual who is under a duty of care. The requirements of the standard are closely dependent on circumstances. Whether the standard of care has been breached is determined by the trier of fact, and is usually phrased in terms of the reasonable person; this is sometimes labeled as the "reasonable physician standard." It was famously described in '' Vaughn v. Menlove'' (1837) as whether the individual "proceed dwith such reasonable caution as a prudent man would have exercised under such circumstances". Professional standard of care In certain industries and professions, the standard of care is determined by the standard that would be exercised by the reasonably prudent manufacturer of a product, or the reasonably prudent professional in that line of work. Such a test (known as the "Bolam Test") was used to determine whether a doctor was liable for medical malpractice before the 2015 UK ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Placebo
A placebo ( ) is a substance or treatment which is designed to have no therapeutic value. Common placebos include inert tablets (like sugar pills), inert injections (like Saline (medicine), saline), sham surgery, and other procedures. In general, placebos can affect how patients perceive their condition and encourage the body's chemical processes for relieving pain and a few other symptoms, but have no impact on the disease itself. Improvements that patients experience after being treated with a placebo can also be due to unrelated factors, such as regression to the mean (a statistical effect where an unusually high or low measurement is likely to be followed by a less extreme one). The use of placebos in clinical medicine raises ethical concerns, especially if they are disguised as an active treatment, as this introduces dishonesty into the doctor–patient relationship and bypasses informed consent. While it was once assumed that this deception was necessary for placebos to have ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Influenza
Influenza, commonly known as "the flu", is an infectious disease caused by influenza viruses. Symptoms range from mild to severe and often include fever, runny nose, sore throat, muscle pain, headache, coughing, and fatigue. These symptoms begin from one to four days after exposure to the virus (typically two days) and last for about 2–8 days. Diarrhea and vomiting can occur, particularly in children. Influenza may progress to pneumonia, which can be caused by the virus or by a subsequent bacterial infection. Other complications of infection include acute respiratory distress syndrome, meningitis, encephalitis, and worsening of pre-existing health problems such as asthma and cardiovascular disease. There are four types of influenza virus, termed influenza viruses A, B, C, and D. Aquatic birds are the primary source of Influenza A virus (IAV), which is also widespread in various mammals, including humans and pigs. Influenza B virus (IBV) and Influenza C virus (ICV) pri ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Seasonal Affective Disorder
Seasonal affective disorder (SAD) is a mood disorder subset, in which people who have normal mental health throughout most of the year exhibit depressive symptoms at the same time each year. Common symptoms include sleeping too much, having little to no energy, and overeating. The condition in the summer can include heightened anxiety.Seasonal affective disorder (SAD): Symptoms MayoClinic.com (September 22, 2011). Retrieved on March 24, 2013. In the '''' DSM-IV and |
Ecological Fallacy
An ecological fallacy (also ecological ''inference'' fallacy or population fallacy) is a formal fallacy in the interpretation of statistical data that occurs when inferences about the nature of individuals are deduced from inferences about the group to which those individuals belong. "Ecological fallacy" is a term that is sometimes used to describe the fallacy of division, which is not a statistical fallacy. The four common statistical ecological fallacies are: confusion between ecological correlations and individual correlations, confusion between group average and total average, Simpson's paradox, and confusion between higher average and higher likelihood. Examples Mean and median An example of ecological fallacy is the assumption that a population mean has a simple interpretation when considering likelihoods for an individual. For instance, if the mean score of a group is larger than zero, this does not imply that a random individual of that group is more likely to have ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Ecological Study
In epidemiology, ecological studies are used to understand the relationship between outcome and exposure at a population level, where 'population' represents a group of individuals with a shared characteristic such as geography, ethnicity, socio-economic status of employment. What differentiates ecological studies from other studies is that the unit analysis being studied is the group, therefore inferences cannot be made about individual study participants. On the other hand, details of outcome and exposure can be generalized to the population being studied. Examples of such studies include investigating associations between units of grouped data, such as electoral wards, regions, or even whole countries. Study Design Generally, three different designs can be used to conduct ecological studies depending on the situation. Such studies may compare populations or groups using a multiple-group design, periods of time using a time-trend design, or groups and time using a mixed design. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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