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design of experiments The design of experiments (DOE, DOX, or experimental design) is the design of any task that aims to describe and explain the variation of information under conditions that are hypothesized to reflect the variation. The term is generally associ ...
, hypotheses are applied to
experimental unit In statistics, a unit is one member of a set of entities being studied. It is the main source for the mathematical abstraction of a " random variable". Common examples of a unit would be a single person, animal, plant, manufactured item, or countr ...
s in a treatment group. In comparative experiments, members of a control group receive a standard treatment, a
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 ...
, or no treatment at all. There may be more than one treatment group, more than one control group, or both. A placebo control group can be used to support a
double-blind study In a blind or blinded experiment, information which may influence the participants of the experiment is withheld until after the experiment is complete. Good blinding can reduce or eliminate experimental biases that arise from a participants' expec ...
, in which some subjects are given an ineffective treatment (in medical studies typically a sugar pill) to minimize differences in the experiences of subjects in the different groups; this is done in a way that ensures no participant in the experiment (subject or experimenter) knows to which group each subject belongs. In such cases, a third, non-treatment control group can be used to measure the
placebo effect 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 ...
directly, as the difference between the responses of placebo subjects and untreated subjects, perhaps paired by age group or other factors (such as being twins). For the conclusions drawn from the results of an experiment to have
validity Validity or Valid may refer to: Science/mathematics/statistics: * Validity (logic), a property of a logical argument * Scientific: ** Internal validity, the validity of causal inferences within scientific studies, usually based on experiments ** ...
, it is essential that the items or patients assigned to treatment and
control groups In the design of experiments, hypotheses are applied to experimental units in a treatment group. In comparative experiments, members of a control group receive a standard treatment, a placebo, or no treatment at all. There may be more than one t ...
be representative of the same
population Population typically refers to the number of people in a single area, whether it be a city or town, region, country, continent, or the world. Governments typically quantify the size of the resident population within their jurisdiction using a ...
. In some experiments, such as many in agriculture or psychology, this can be achieved by randomly assigning items from a common population to one of the treatment and control groups. In studies of twins involving just one treatment group and a control group, it is statistically efficient to do this random assignment separately for each pair of twins, so that one is in the treatment group and one in the control group. In some medical studies, where it may be unethical not to treat patients who present with symptoms, controls may be given a standard treatment, rather than no treatment at all. An alternative is to select controls from a wider population, provided that this population is well-defined and that those presenting with symptoms at the clinic are representative of those in the wider population. Another method to reduce ethical concerns would be to test early-onset symptoms, with enough time later to offer real treatments to the control subjects, and let those subjects know the first treatments are "experimental" and might not be as effective as later treatments, again with the understanding there would be ample time to try other remedies. __TOC__


Relevance

A clinical control group can be a placebo arm or it can involve an old method used to address a clinical outcome when testing a new idea. For example in a study released by the British Medical Journal, in 1995 studying the effects of strict blood pressure control versus more relaxed blood pressure control in diabetic patients, the clinical control group was the diabetic patients that did not receive tight blood pressure control. In order to qualify for the study, the patients had to meet the inclusion criteria and not match the exclusion criteria. Once the study population was determined, the patients were placed in either the experimental group (strict blood pressure control <150/80mmHg) versus non strict blood pressure control (<180/110). There were a wide variety of ending points for patients such as death, myocardial infarction, stroke, etc. The study was stopped before completion because strict blood pressure control was so much superior to the clinical control group which had relaxed blood pressure control. The study was no longer considered ethical because tight blood pressure control was so much more effective at preventing end points that the clinical control group had to be discontinued. The clinical control group is not always a placebo group. Sometimes the clinical control group can involve comparing a new drug to an older drug in a superiority trial. In a superiority trial, the clinical control group is the older medication rather than the new medication. For example in the ALLHAT trial, Thiazide diuretics were demonstrated to be superior to calcium channel blockers or
angiotensin-converting enzyme Angiotensin-converting enzyme (), or ACE, is a central component of the renin–angiotensin system (RAS), which controls blood pressure by regulating the volume of fluids in the body. It converts the hormone angiotensin I to the active vasoconstr ...
inhibitors in reducing cardiovascular events in high risk patients with hypertension. In the ALLHAT study, the clinical control group was not a placebo it was ACEI or Calcium Channel Blockers.The ALLHAT Study
/ref> Overall, clinical control groups can either be a placebo or an old standard of therapy.


See also

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Scientific control A scientific control is an 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 betwe ...
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Wait list control group A wait list control group, also called a wait list comparison, is a group of participants included in an outcome study that is assigned to a waiting list and receives intervention after the active treatment group. This control group serves as an ...
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Blocking (statistics) In the statistical theory of the design of experiments, blocking is the arranging of experimental units in groups (blocks) that are similar to one another. Blocking can be used to tackle the problem of pseudoreplication. Use Blocking reduces un ...
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Hawthorne effect The Hawthorne effect is a type of reactivity in which individuals modify an aspect of their behavior in response to their awareness of being observed. The effect was discovered in the context of research conducted at the Hawthorne Western Electri ...


References

{{Authority control Design of experiments Clinical research