Page 7 - Terminology-Clinical-Research

assignment prevents selection bias, it does not guarantee bioavailability of two products must not differ significantly
that the groups are equivalent at baseline. Any differences when the two products are given in studies at the same
in baseline characteristics are, however, the result of chance dosage under similar conditions.
rather than bias. The study groups should be compared
at baseline for important demographic and clinical Biological marker: See Biomarker.
characteristics. Baseline data may be especially valuable Biologics Licencing Application (BLA): An application to
when the outcome measure can also be measured at the
start of the trial. FDA for a license to market a new biologic product in the
United States.
Baseline imbalance: Systematic error in creating
intervention groups, such that they differ with respect Biomarker: A characteristic that is objectively measured
and evaluated as an indicator of normal biological
to prognosis. That is, the groups differ in measured or processes, pathogenic processes, or pharmacologic
unmeasured baseline characteristics because of the way
participants were selected or assigned. Note: Also used responses to a therapeutic intervention.
to mean that the participants are not representative of the Biometric signature: A signature based on the verification
population of all possible participants. of an individual’s identity, based on measurement of the
individual’s physical feature(s) or repeatable action(s),
Bayesian approaches: Approaches to data analysis that where those features and/or actions are both unique to that
provide a posterior probability distribution for some
parameter (e.g., treatment effect), derived from the individual, and measureable.
observed data and a prior probability distribution for the Biostatistics: Branch of statistics applied to the analysis of
parameter. The posterior distribution is then used as the biological phenomena.
basis for statistical inference.
Biotechnology: Biotechnology is the application of
Bayesian statistics: Statistical approach named for Thomas biological organisms, systems or process to manufacturing
Bayes (1701–1761) that has among its features giving a of pharmaceuticals.
subjective interpretation to probability, accepting the idea
that it is possible to talk about the probability of hypotheses BLA: See Biologics Licencing Application.
being true and of parameters having particular values.
Blind review: Checking and assessing data prior to
Beta error: Probability of showing no significant breaking the blind, for the purpose of finalizing the planned
difference when a true difference exists; a false acceptance analysis.
of the null hypothesis.
Blinded (masked) medications: Products that appear
Between-subject variation: In a parallel trial design, identical in size, shape, color, flavor, and other attributes
differences between subjects are used to assess treatment to make it very difficult for subjects and investigators
differences. (or anyone assessing the outcome) to determine which
medication is being administered.
Bias: Situation or condition that causes a result to depart
from the true value in a consistent direction. Bias refers to Blinded study: A study in which the subject, the
defects in study design or measurement. In clinical studies, investigator, or anyone assessing the outcome is unaware
bias is controlled by blinding and randomization. of the treatment assignment(s). Note: Blinding is used to
reduce the potential for bias.
Bioanalytical assays: Methods for quantitative
measurement of a drug, drug metabolites, or chemicals in Blinding/masking): A clinical trial design strategy in
biological fluids. which one or more parties involved in the trial, such
as the investigator or participants, do not know which
Bioavailability: Rate and extent to which a drug is participants have been assigned which interventions. Types
absorbed or is otherwise available to the treatment site in of Masking include Open Label, Single Blind Masking, and
the body. Double Blind Masking. Note: Masking, while often used
synonymously with blinding, usually denotes concealing
Bioequivalence study: Bioequivalence is a term in
pharmacokinetics used to assess the expected in vivo the specific study intervention used. The term masking is
biological equivalence of two preparations of a Medicinal often preferred to blinding in the field of ophthalmology.
Product. Note: To be considered bioequivalent, the Branch: Point within a study design where there is an

TERMINOLOGY CLINICAL RESEARCH 7