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Mean: The sum of all values of all observations or data points divided by the number of observations, an arithmetical average.
Median: The middle value in a data set; that is, just as many values are greater than the median and less than the medial value.
Mode: (statistics) The most frequently occurring value in a data set.
National Institutes of Health (NIH): A government agency which conducts and/or funds both basic and clinical research.
New Drug Application (NDA): An application to the FDA for a license to market a new drug in the United States.
Non-Inferiority Trial: A trial with the primary objective of showing that the response to the investigational drug is not clinically inferior to a comparative agent (active or placebo control).
Open Label: No individuals are blinded to treatment assignment (eg, investigators, subject and sponsor know the identity of the treatment assignment). For randomized open label trials, the "blind" with respect to the randomization sequence should be maintained up to the time when a patient is actually randomized.
Open Study/Open-Label Study: A trial in which subject and investigators know which product each subject is receiving; opposite of double-blind.
Orphan Drug: A drug for a rare disease or condition for which the FDA can allow expedited review and provide certain competitor protection in order to reduce cost and provide financial incentives for development of such drugs.
Patient: Person under a physician's care for a particular disease or condition. See also subject/trial subject, healthy volunteer.
Pharmacodynamics (PD): The branch of pharmacology that studies reactions between drugs and living structures, including the processes of bodily responses to pharmacological, biochemical, physiological and therapeutic effects.
Pharmacoeconomics: Branch of economics that applies cost-effectiveness, cost-minimization and cost-utility analyses to compare the economics of different pharmaceutical products or to compare drug therapy to other treatments.
Pharmacology: The science that deals with the characteristics, effects and uses of drugs and their interactions with living organisms.
Phase 1: The stage of drug development when the investigational product is first researched in humans and when drug safety is determined. Usually a small number of healthy volunteers but occasionally patients participate in these studies.
Phase 2: The stage in which drug effectiveness is determined preliminary in patients with the targeted medical condition. These studies are aimed to assess short-term safety and therapeutic dose-range finding (minimum and maximum doses) and determine short-term side effects and risks associated with the investigational product. Usually a moderate numbers of patients (100-250) participate in these studies.
Phase 3: The stage in which large-scale safety and effectiveness are ascertained in a larger number of patients who ultimately will receive the investigational product. These studies are aimed to demonstrate short and long term safety and efficacy and assess overall therapeutic value as well as determined the benefit/risk relationship of the investigational product.
Phase 4: These studies are performed after the investigational product is approved for a medical condition by the Food and Drug Administration (FDA) to gather additional data about the product.
Placebo (Placebo Control): An inactive product used for testing against the active drug to better understand the actions of the active drug.
Preclinical Study: Testing of drugs in the laboratory setting prior to their evaluation in humans. Data about a drug's activities and effects in animals help establish boundaries for safe use of the drug in subsequent human testing (clinical trials).
Prevention Study: Studies treatments that may help avoid a disease.
Protocol: The plan that is followed in a clinical trial which describes the objective(s), design, methodology, statistical considerations, and organization of a trial.
Quality-of-Life: A type of clinical trial that study an investigational drug to see if it can help improve a person's life while sick.
Random Allocation (Random Assignment): Assignment of subjects to treatment (or control) groups in an unpredictable way.
Randomization: There may be several different treatments being compared in a clinical trial; to avoid any unfair concentration on any particular treatment, patients are assigned treatments at random by a computer.
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