Study Design
Clinical study design is the formulation of clinical trials and other experiments, as well as observational studies, in medical research involving human beings and involving clinical aspects, including epidemiology . It is the design of experiments as applied to these fields. 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 medical ethics. Outline of types of desig ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, pharmaceutical drug, drugs, medical nutrition therapy, 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 institutional review board, 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 experiment, pi ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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Quasi-experiment
A quasi-experiment is a research design used to estimate the causal impact of an intervention. Quasi-experiments share similarities with experiments and randomized controlled trials, but specifically lack random assignment to treatment or control. Instead, quasi-experimental designs typically allow assignment to treatment condition to proceed how it would in the absence of an experiment. Quasi-experiments are subject to concerns regarding internal validity, because the treatment and control groups may not be comparable at baseline. In other words, it may not be possible to convincingly demonstrate a causal link between the treatment condition and observed outcomes. This is particularly true if there are confounding variables that cannot be controlled or accounted for. With random assignment, study participants have the same chance of being assigned to the intervention group or the comparison group. As a result, differences between groups on both observed and unobserved characteri ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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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. From a statistical point of view, these ideas can be unified by specifying proper statistical models to make formal inferences, using aggregate data to make unobserved relationships in individual level data. Examples Mean and median An example of ecological fallacy is the assumption that a population mean has a simple in ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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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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Cross-sectional Study
In statistics and econometrics, cross-sectional data is a type of data collected by observing many subjects (such as individuals, firms, countries, or regions) at a single point or period of time. Analysis of cross-sectional data usually consists of comparing the differences among selected subjects, typically with no regard to differences in time. For example, if we want to measure current obesity levels in a population, we could draw a sample of 1,000 people randomly from that population (also known as a cross section of that population), measure their weight and height, and calculate what percentage of that sample is categorized as obese. This cross-sectional sample provides us with a snapshot of that population, at that one point in time. Note that we do not know based on one cross-sectional sample if obesity is increasing or decreasing; we can only describe the current proportion. Cross-sectional data differs from ''time series'' data, in which the same small-scale or aggreg ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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Nested Case-control Study
''Nested'' is the seventh studio album by Bronx-born singer, songwriter, and pianist Laura Nyro. It was released in 1978 on Columbia Records. Following on from her extensive tour to promote 1976's ''Smile'', which resulted in the 1977 live album '' Season of Lights'', Nyro retreated to her new home in Danbury, Connecticut, where she lived after spending her time in the spotlight in New York City. Nyro had a studio built at her home and recorded there the songs that comprised ''Nested''. The songs deal with themes such as motherhood and womanhood, and Nyro is notably more relaxed in her singing on the album. The instrumentation is laid back and smooth, similar to that of ''Smile'', but perhaps less jazz-inspired and more melodic. Nyro was assisted in production by Roscoe Harring, while Dale and Pop Ashby were chief engineers. Critics praised the album as a melodic return to form, and Nyro supported the album with a solo tour when she was heavily pregnant with her son Gil, who wa ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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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 ''f ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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Retrospective Cohort Study
A retrospective cohort study, also called a historic cohort study, is a longitudinal cohort study used in medical and psychological research. A cohort of individuals that share a common exposure factor is compared with another group of equivalent individuals not exposed to that factor, to determine the factor's influence on the incidence of a condition such as disease or death. Retrospective cohort studies have existed for approximately as long as prospective cohort studies. Design The retrospective cohort study compares groups of individuals who are alike in many ways but differ by a certain characteristic (for example, female nurses who smoke and ones who do not smoke) in terms of a particular outcome (such as lung cancer). Data on the relevant events for each individual (the form and time of exposure to a factor, the latent period, and the time of any subsequent occurrence of the outcome) are collected from existing records and can immediately be analyzed to determine the ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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Prospective Cohort Study
A prospective cohort study is a longitudinal cohort study that follows over time a group of similar individuals ( cohorts) who differ with respect to certain factors under study to determine how these factors affect rates of a certain outcome. For example, one might follow a cohort of middle-aged truck drivers who vary in terms of smoking habits to test the hypothesis that the 20-year incidence rate of lung cancer will be highest among heavy smokers, followed by moderate smokers, and then non–smokers. The prospective study is important for research on the etiology of diseases and disorders. The distinguishing feature of a prospective cohort study is that at the time the investigators begin enrolling subjects and collecting baseline exposure information, none of the subjects have developed any of the outcomes of interest. After baseline information is collected, subjects in a prospective cohort study are then followed "longitudinally," i.e., over a period of time, usually for ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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Cohort Study
A cohort study is a particular form of longitudinal study that samples a Cohort (statistics), cohort (a group of people who share a defining characteristic, typically those who experienced a common event in a selected period, such as birth or graduation), performing a Cross-sectional data, cross-section at intervals through time. It is a type of panel study where the individuals in the panel share a common characteristic. Cohort studies represent one of the fundamental designs of epidemiology which are used in research in the fields of medicine, pharmacy, nursing, Psychological research, psychology, social science, and in any field reliant on 'difficult to reach' answers that are based on evidence (statistics). In medicine for instance, while clinical trials are used primarily for assessing the safety of newly developed pharmaceuticals before they are approved for sale, epidemiological analysis on how risk factors affect the incidence of diseases is often used to identify the caus ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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Population Study
Population study is an interdisciplinary field of scientific study that uses various statistical methods and models to analyse, determine, address, and predict population challenges and trends from data collected through various data collection methods such as population census, registration method, sampling, and some other systems of data sources. In the various fields of healthcare, a population study is a study of a group of individuals taken from the general population who share a common characteristic, such as age, sex, or health condition. This group may be studied for different reasons, such as their response to a drug or risk of getting a disease. See also *Demography Demography () is the statistical study of human populations: their size, composition (e.g., ethnic group, age), and how they change through the interplay of fertility (births), mortality (deaths), and migration. Demographic analysis examine ... References External links Population studye ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |