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Translation glossary: Clinical Trials glossary

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ADVERSE REACTION

(Adverse Event.) An unwanted effect caused by the administration of drugs. Onset may be sudden or develop over time (See Side Effects).

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ADVOCACY AND SUPPORT GROUPS

Organizations and groups that actively support participants and their families with valuable resources, including self-empowerment and survival tools

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In the U.S., the Food and Drug Administration (FDA) must approve a substance as a drug before it can be marketed. The approval process involves sever

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Any of the treatment groups in a randomized trial. Most randomized trials have two \"arms,\" but some have three \"arms,\" or even more (See Randomiz

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1. Information gathered at the beginning of a study from which variations found in the study are measured. 2. A known value or quantity with which an

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When a point of view prevents impartial judgment on issues relating to the subject of that point of view. In clinical studies, bias is controlled by

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A randomized trial is \"Blind\" if the participant is not told which arm of the trial he is on. A clinical trial is \"Blind\" if participants are una

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Pertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science.

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CLINICAL ENDPOINT

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CLINICAL INVESTIGATOR

A medical researcher in charge of carrying out a clinical trial\'s protocol.

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A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical tri

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In epidemiology, a group of individuals with some characteristics in common.

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COMMUNITY-BASED CLINICAL TRIAL (CBCT)

A clinical trial conducted primarily through primary-care physicians rather than academic research facilities.

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COMPASSIONATE USE

A method of providing experimental therapeutics prior to final FDA approval for use in humans. This procedure is used with very sick individuals who

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COMPLEMENTARY AND ALTERNATIVE THERAPY

Broad range of healing philosophies, approaches, and therapies that Western (conventional) medicine does not commonly use to promote well-being or tr

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CONFIDENTIALITY REGARDING TRIAL PARTICIPANTS

Refers to maintaining the confidentiality of trial participants including their personal identity and all personal medical information. The trial par

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CONTRAINDICATION

A specific circumstance when the use of certain treatments could be harmful.

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A control is the nature of the intervention control.

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The standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or t

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CONTROLLED TRIALS

Control is a standard against which experimental observations may be evaluated. In clinical trials, one group of participants is given an experimenta

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DATA SAFETY AND MONITORING BOARD (DSMB)

An independent committee, composed of community representatives and clinical research experts, that reviews data while a clinical trial is in progres

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DIAGNOSTIC TRIALS

Refers to trials that are are conducted to find better tests or procedures for diagnosing a particular disease or condition. Diagnostic trials usuall

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DOSE-RANGING STUDY

A clinical trial in which two or more doses of an agent (such as a drug) are tested against each other to determine which dose works best and is leas

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DOUBLE-BLIND STUDY

A clinical trial design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental dr

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DOUBLE-MASKED STUDY

See Double-Blind Study.

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DRUG-DRUG INTERACTION

A modification of the effect of a drug when administered with another drug. The effect may be an increase or a decrease in the action of either subst

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See Data Safety and Monitoring Board.

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(Of a drug or treatment). The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is

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ELIGIBILITY CRITERIA

Summary criteria for participant selection; includes Inclusion and Exclusion criteria. (See Inclusion/Exclusion Criteria)

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Based on experimental data, not on a theory.

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Overall outcome that the protocol is designed to evaluate. Common endpoints are severe toxicity, disease progression, or death.

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The branch of medical science that deals with the study of incidence and distribution and control of a disease in a population.

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EXCLUSION/INCLUSION CRITERIA

See Inclusion/Exclusion Criteria.

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EXPANDED ACCESS

Refers to any of the FDA procedures, such as compassionate use, parallel track, and treatment IND that distribute experimental drugs to participants

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EXPERIMENTAL DRUG

A drug that is not FDA licensed for use in humans, or as a treatment for a particular condition (See Off-Label Use).

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See Food and Drug Administration.

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FOOD AND DRUG ADMINISTRATION (FDA)

The U.S. Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and

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A supposition or assumption advanced as a basis for reasoning or argument, or as a guide to experimental investigation.

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INCLUSION/EXCLUSION CRITERIA

The medical or social standards determining whether a person may or may not be allowed to enter a clinical trial. These criteria are based on such fa

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See Investigational New Drug.

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INFORMED CONSENT

The process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughou

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INFORMED CONSENT DOCUMENT

A document that describes the rights of the study participants, and includes details about the study, such as its purpose, duration, required procedu

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INSTITUTIONAL REVIEW BOARD (IRB)

1. A committee of physicians, statisticians, researchers, community advocates, and others that ensures that a clinical trial is ethical and that the

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INTENT TO TREAT

Analysis of clinical trial results that includes all data from participants in the groups to which they were randomized ( See Randomization) even if

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INTERVENTION NAME

The generic name of the precise intervention being studied.

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Primary interventions being studied

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INVESTIGATIONAL NEW DRUG

A new drug, antibiotic drug, or biological drug that is used in a clinical investigation. It also includes a biological product used in vitro for dia

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See Institutional Review Board.

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The knowledge of intervention assignment. See Blind

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NATURAL HISTORY STUDY

Study of the natural development of something (such as an organism or a disease) over a period of time.

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