A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z
Adverse Event (AE): see Side Effects Bioavailability: Rate and extent to which a drug is absorbed or is otherwise available to the treatment site in the body.Bioequivalence: Scientific basis on which generic and brand-name drugs are compared. To be considered bioequivalent, the bioavailability of two products must not differ significantly when the two products are given in studies at the same dosage under similar conditions.
Biologic License Applications (BLA): The application submitted to the FDA, usually after completion of Phase 3 trials, which shows clinical efficacy and safety of a biologic product in humans, and requests marketing approval in the United States. Formerly known as Product License Applications (PLA).
Blinding: A procedure in which one or more parties (subject, investigator, sponsor) to the trial are kept unaware of which study drug the subject is given until the completion of the study.
Center for Biologics Evaluation and Research (CBER): A center within the Food and Drug Administration responsible for ensuring the safety and efficacy of blood and blood products, vaccines, allergenics, and certain biological therapeutics.
Center For Drug Evaluation and Research (CDER): A center within the Food and Drug Administration (FDA) which is responsible for ensuring the safety and efficacy of drug products, including certain biological therapeutics.
Clinical Trial: An investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational drug, and/or to identify any adverse events to any investigational drug, and/or to study absorption, distribution, metabolism, and excretion of an investigational drug with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.
Cohort: Group of subjects enrolled concurrently or sequentially under a similar study design with the same treatment group. A study may be made up of one or more cohorts.
Comparative Study: One in which the investigative drug is compared against another study drug, either active drug or placebo.
Comparator (product): An investigational drug or marketed product (ie, active control) or placebo used as a reference in a clinical trial.
Control: In a clinical trial, one therapy must be tested against another to determine if there are any differences between treatments. The control is the treatment being tested against the new therapy and may or may not be a therapy that is already considered standard treatment for the disease.
Consent Form: see Informed Consent
Control Group: see Control
Controlled Study: A study in which an investigational drug is compared with a treatment that has known effects. The control group may receive no treatment, standard treatment, or placebo.
Doctor: see Investigator
Double-Blind Study: A research study in which neither the subject(s) nor the investigator(s) know what treatment a subject is receiving until the study is completed.
Double Dummy: A technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be made identical. Supplies are prepared for Treatment A (active and indistinguishable placebo) and for Treatment B (active and indistinguishable placebo). Subjects then take two sets of treatment; either A (active) and B (placebo) or A (placebo) and B (active).
Efficacy: A product's ability to produce beneficial effects on the course or duration of a disease.
Eligibility Criteria (Inclusion/Exclusion Criteria): The requirements that people must meet before they can participate in a clinical trial.
Equivalence Trial: A trial with the primary objective of showing that the response to two or more treatments differs by an amount which is clinically unimportant. That is usually demonstrated by showing that the true treatment difference is likely to lie between a lower and an upper equivalence margin of clinically acceptable differences.
Ethics Committee: see Independent Ethics Committee
Exclusion Criteria: see Eligibility Criteria
FDA: see Food and Drug Administration
Financial Disclosure: An FDA required document requiring disclosure of certain financial arrangements between sponsors and clinical investigators that may potentially bias clinical trial data from 'covered studies'.
Food and Drug Administration (FDA): The U.S. regulatory agency responsible for protecting the health of people through drug research and approval.
A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z
Return to About Clinical Trial Index
