Category: B

Burden to patients

The additional load that a clinical activity imposes on patients above that which would be experienced under normal clinical practice. Source: (CIOMS XI: Patient involvement

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Bonferroni Correction

A correction to allow for the probability of many events that are independent, named after Carlo Emilio Bonferroni (1892-1960). In statistical significance testing, it allows,

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A measured characteristic of either normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. Molecular, histologic, radiographic, or physiologic

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Binary Analysis

An analysis involving only two categories (e.g., baseline vs final values, in contrast to analysis of multiple values from continuous measurements, as for a progression

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A theorem in probability named after Reverend Thomas Bayes (1702-1761). It is used to refer to a philosophy of statistics that treats probability statements as

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Baseline characteristics

Factors that describe study participants at the beginning of the study (e.g., age, sex, disease severity). In comparison studies, it is importantthat these characteristics be

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Benefit-Risk Assessments

Analysis of the favorable (beneficial) and unfavorable results of doing specific actions. Also called “benefit-harm” or “effectiveness-risk” analysis

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Blinding / Masking

A clinical trial design strategy in which one or more parties involved in the trial, such as the investigator or participants, do not know which

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The ability of a drug or other substance to be absorbed and used by the body. Orally bioavailable means that a drug or other substance

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Biologic Product

[FDA] FDA: A biologic product is any virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the

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