Clinical trialClinical 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.
Randomized controlled trialA randomized controlled trial (or randomized control trial; RCT) is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures or other medical treatments. Participants who enroll in RCTs differ from one another in known and unknown ways that can influence study outcomes, and yet cannot be directly controlled.
ConfoundingIn causal inference, a confounder (also confounding variable, confounding factor, extraneous determinant or lurking variable) is a variable that influences both the dependent variable and independent variable, causing a spurious association. Confounding is a causal concept, and as such, cannot be described in terms of correlations or associations. The existence of confounders is an important quantitative explanation why correlation does not imply causation.
Clinical researchClinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment.
Placebo-controlled studyPlacebo-controlled studies are a way of testing a medical therapy in which, in addition to a group of subjects that receives the treatment to be evaluated, a separate control group receives a sham "placebo" treatment which is specifically designed to have no real effect. Placebos are most commonly used in blinded trials, where subjects do not know whether they are receiving real or placebo treatment. Often, there is also a further "natural history" group that does not receive any treatment at all.
New Drug ApplicationThe Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug development, concluding with an approved NDA, if successful. The goals of the NDA are to provide enough information to permit FDA reviewers to establish the complete history of the candidate drug.
Detached objectDetached objects are a dynamical class of minor planets in the outer reaches of the Solar System and belong to the broader family of trans-Neptunian objects (TNOs). These objects have orbits whose points of closest approach to the Sun (perihelion) are sufficiently distant from the gravitational influence of Neptune that they are only moderately affected by Neptune and the other known planets: This makes them appear to be "detached" from the rest of the Solar System, except for their attraction to the Sun.
Clinical study designClinical 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).
WeightIn science and engineering, the weight of an object is the force acting on the object due to acceleration or gravity. Some standard textbooks define weight as a vector quantity, the gravitational force acting on the object. Others define weight as a scalar quantity, the magnitude of the gravitational force. Yet others define it as the magnitude of the reaction force exerted on a body by mechanisms that counteract the effects of gravity: the weight is the quantity that is measured by, for example, a spring scale.
Data analysisData analysis is the process of inspecting, cleansing, transforming, and modeling data with the goal of discovering useful information, informing conclusions, and supporting decision-making. Data analysis has multiple facets and approaches, encompassing diverse techniques under a variety of names, and is used in different business, science, and social science domains. In today's business world, data analysis plays a role in making decisions more scientific and helping businesses operate more effectively.
Scatter plotA scatter plot (also called a scatterplot, scatter graph, scatter chart, scattergram, or scatter diagram) is a type of plot or mathematical diagram using Cartesian coordinates to display values for typically two variables for a set of data. If the points are coded (color/shape/size), one additional variable can be displayed. The data are displayed as a collection of points, each having the value of one variable determining the position on the horizontal axis and the value of the other variable determining the position on the vertical axis.
Weighing scaleA scale or balance is a device used to measure weight or mass. These are also known as mass scales, weight scales, mass balances, and weight balances. The traditional scale consists of two plates or bowls suspended at equal distances from a fulcrum. One plate holds an object of unknown mass (or weight), while objects of known mass or weight, called weights, are added to the other plate until static equilibrium is achieved and the plates level off, which happens when the masses on the two plates are equal.
Plot (graphics)A plot is a graphical technique for representing a data set, usually as a graph showing the relationship between two or more variables. The plot can be drawn by hand or by a computer. In the past, sometimes mechanical or electronic plotters were used. Graphs are a visual representation of the relationship between variables, which are very useful for humans who can then quickly derive an understanding which may not have come from lists of values.
Exploratory data analysisIn statistics, exploratory data analysis (EDA) is an approach of analyzing data sets to summarize their main characteristics, often using statistical graphics and other data visualization methods. A statistical model can be used or not, but primarily EDA is for seeing what the data can tell us beyond the formal modeling and thereby contrasts traditional hypothesis testing. Exploratory data analysis has been promoted by John Tukey since 1970 to encourage statisticians to explore the data, and possibly formulate hypotheses that could lead to new data collection and experiments.
Food and Drug AdministrationThe 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.
Trans-Neptunian objectA trans-Neptunian object (TNO), also written transneptunian object, is any minor planet in the Solar System that orbits the Sun at a greater average distance than Neptune, which has a semi-major axis of 30.1 astronomical units (au). Typically, TNOs are further divided into the classical and resonant objects of the Kuiper belt, the scattered disc and detached objects with the sednoids being the most distant ones. As of October 2020, the catalog of minor planets contains 678 numbered and more than 2,000 unnumbered TNOs.
Consolidated Standards of Reporting TrialsConsolidated Standards of Reporting Trials (CONSORT) encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of randomized controlled trials. It is part of the larger EQUATOR Network initiative to enhance the transparency and accuracy of reporting in research. The main product of the CONSORT Group is the CONSORT Statement, which is an evidence-based, minimum set of recommendations for reporting randomized trials.
Scientific controlInformal improvements in any process or enquiry have been made by comparison between what was done previously and the new method for thousands of years. A scientific control is a modern formal experiment or observation designed to minimize the effects of variables other than the independent variable (i.e. confounding variables). This increases the reliability of the results, often through a comparison between control measurements and the other measurements. Scientific controls are a part of the scientific method.
Investigational New DrugThe United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. Regulations are primarily at . Similar procedures are followed in the European Union, Japan, and Canada. Commercial INDs are filed by companies to obtain marketing approval for a new drug.
CausalityCausality (also called causation, or cause and effect) is influence by which one event, process, state, or object (a cause) contributes to the production of another event, process, state, or object (an effect) where the cause is partly responsible for the effect, and the effect is partly dependent on the cause. In general, a process has many causes, which are also said to be causal factors for it, and all lie in its past. An effect can in turn be a cause of, or causal factor for, many other effects, which all lie in its future.
