Clinical Trial Terminology Archives - Page 9 of 24

Placebo Controlled Study (Arm)

Subjects are randomly assigned to an experimental treatment or to a placebo group, sometimes known as “negative control”. The placebo group receives an inactive treatment that is identical-appearing to the […]

Placebo Comparator Arm

A group of participants that receives a placebo during a clinical study. One of several Arm Types.

Placebo

A substance that does not contain active ingredients and is made to be physically indistinguishable (i.e., it looks and tastes identical) from the actual drug being studied.

Personally Identifiable Information (PII)

Any information maintained by an agency, including: (1) any information that can be used to distinguish or trace an individual’s identity, such as name, social security number, date and place […]

Phase IV (Therapeutic Use)

Confirmatory stage of clinical research undertaken after local regulatory approval has been obtained. Trials are limited to drug’s approved indications, dosage forms, dosage ranges, routes of administration, and subject population. […]

Phase III (Therapeutic Confirmatory)

Stage of clinical research in which the experimental drug is administered in large-scale trials to establish safety and efficacy. Phase III (a): Phase IIIa trials are conducted after the drug’s […]

Phase II (Therapeutic Exploratory)

Stage of clinical research in which the experimental drug is administered to limited numbers of subjects in whom it appears to be indicated in order to define a therapeutic dose […]

Phase I (Human Pharmacology)

Stage of clinical research in which the experimental drug is administered to small numbers of normal human volunteers or to a carefully defined subject population under controlled conditions to obtain […]

Phase

Food and Drug Administration (FDA) categories (http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm) for describing the clinical trial of a drug based on the study’s characteristics, such as the objective and number of participants. There are […]

Pharmacokinetics (Study)

A study of the movement of a drug within a biological system, as affected by absorption, distribution, metabolism, and excretion. (Pfizer)