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Translation glossary: Clinical Trials glossary

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Antonia Jordanova
Antonia Jordanova
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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 GROUPSOrganizations and groups that actively support participants and their families with valuable resources, including self-empowerment and survival tools 
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APPROVED DRUGSIn 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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ARMAny 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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BASELINE1. 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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BIASWhen 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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BLINDA 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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CLINICALPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. 
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CLINICAL ENDPOINTSee Endpoint. 
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CLINICAL INVESTIGATORA medical researcher in charge of carrying out a clinical trial\'s protocol. 
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CLINICAL TRIALA 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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COHORTIn 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 USEA 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 THERAPYBroad 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 PARTICIPANTSRefers to maintaining the confidentiality of trial participants including their personal identity and all personal medical information. The trial par 
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CONTRAINDICATIONA specific circumstance when the use of certain treatments could be harmful. 
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CONTROLA control is the nature of the intervention control. 
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CONTROL GROUPThe 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 TRIALSControl 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 TRIALSRefers 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 STUDYA 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 STUDYA 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 STUDYSee Double-Blind Study. 
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DRUG-DRUG INTERACTIONA 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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DSMBSee Data Safety and Monitoring Board. 
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EFFICACY(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 CRITERIASummary criteria for participant selection; includes Inclusion and Exclusion criteria. (See Inclusion/Exclusion Criteria) 
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EMPIRICALBased on experimental data, not on a theory. 
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ENDPOINTOverall outcome that the protocol is designed to evaluate. Common endpoints are severe toxicity, disease progression, or death. 
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EPIDEMIOLOGYThe 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 CRITERIASee Inclusion/Exclusion Criteria. 
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EXPANDED ACCESSRefers 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 DRUGA 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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FDASee 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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HYPOTHESISA supposition or assumption advanced as a basis for reasoning or argument, or as a guide to experimental investigation. 
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INCLUSION/EXCLUSION CRITERIAThe 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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INDSee Investigational New Drug. 
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INFORMED CONSENTThe 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 DOCUMENTA 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 TREATAnalysis 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 NAMEThe generic name of the precise intervention being studied. 
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INTERVENTIONSPrimary interventions being studied 
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INVESTIGATIONAL NEW DRUGA 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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IRBSee Institutional Review Board. 
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MASKEDThe knowledge of intervention assignment. See Blind 
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NATURAL HISTORY STUDYStudy of the natural development of something (such as an organism or a disease) over a period of time. 
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