Clinical Trials, Overview (2014)

Trial is from the Anglo–French trier, meaning to try. Broadly, it refers to the action or process of putting something to a test or proof. Clinical is from clinic, from the French cliniqué and from the Greek klinike, and refers to the practice of caring for the sick at the bedside. Hence, narrowly, a clinical trial is the action or process of putting something to a test or proof at the bedside of the sick. However, broadly it refers to any testing done on human beings for the sake of determining the value of a treatment for the sick or for preventing disease or sickness. The broad definition of clinical trial includes definitions allowing for use of the term in references to studies involving a single treatment (e.g. as in most phase I trials and some phase II drug trials) and for studies involving use of an external control (e.g. studies involving historical controls (See Historical Controls and Clinical Trials)) 66. However, use herein will be in the stricter sense of usage; that is, to refer to trials involving two or more treatment groups comprised of persons enrolled, treated, and followed over the exact same time frame. The treatment can be anything considered to hold promise in caring for the sick, in the prevention of disease, or in the maintenance of health. The term, in the context of a trial, refers to the experimental variable—the variable manipulated by the trialist. The variable may have just two states (e.g. as in a trial involving a single test treatment and single control treatment) or three or more states (e.g. as in a trial involving several different test treatments and one or more control treatments). The variable, in the case of drug trials, may serve to designate different drugs, different doses of the same drug, or different forms or routes of administration of the same drug. In other contexts, it may variously refer to different kinds or forms of surgery, different kinds or forms of care or management regimens, different kinds or forms of diagnostic tests, different kinds or forms of medical devices, different kinds or forms of counseling regimens to achieve some desired end, or combinations of the above. The clinical trial, in its simplest form, involves the application of the experimental variable—treatment to a person or group of persons—and observation during or following application of the treatment to measure its effect. That measure (outcome measure) may be death, occurrence or recurrence of some morbid condition, or a difference indicative of change (e.g. difference in blood pressure measured for each person just prior to the start of treatment and again at some point during or after treatment). There is no way to “test” a treatment or to “prove” its effectiveness in the absence of some absolute or relative measure of success. Trials are said to be controlled if the effect of a treatment is measured against a comparison treatment administered over the same time period and under similar conditions (See Controls). That comparison treatment may be another test treatment or, depending on circumstances, a control treatment consisting of an accepted standard form of therapy, a placebo (see Blinding or Masking) or sham treatment, or observation only (no treatment). Prove thy servants, I beseech thee, ten days; and let them give us pulse to eat, and water to drink. Then let our countenances be looked upon before thee, and the countenance of the children that eat of the portion of the King's meat: and as thou seest, deal with thy servants. So he consented to them in this matter, and proved them ten days. And at the end of ten days their countenances appeared fairer and fatter in flesh than all the children which did eat the portion of the King's meat 1. I raised myself very early to visit them, when beyond my hope I found those to whom I had applied the digestive medicament, feeling but little pain, their wounds neither swollen nor inflamed, and having slept through the night. The others to whom I had applied the boiling oil were feverish with much pain and swelling about their wounds. Then I determined never again to burn thus so cruelly the poor wounded by arquebuses 72. On the 20th of May 1747, I took twelve patients in the scurvy, on board the Salisbury at sea. Their cases were as similar as I could have them. They all in general had putrid gums, the spots and lassitude, with weakness of their knees. They lay together in one place, being a proper apartment for the sick in the fore-hold; and had one diet common to all, viz., watergruel sweetened with sugar in the morning; fresh mutton-broth often for at other with and for and and and or the of were each a of a others took of three a upon an a with it for their others took two of three a upon an having their and their other with as the for their of the with the in the of the were under a of this a and more or as it by way of others had each two and one them eat with at different upon an They but days under this having the that could be The two took the of a three of an by an of of and for common with by a of with the of were three or during the the most and were from the use of and one of those had them being at the end of days for The treatment general term, or trial (see Clinical Trials meaning and refers to the of in a of the trial the treatments being the and of and and conditions under which other treatments are for when for the 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