Page 34 - Terminology-Clinical-Research

have been assigned which interventions. Types of Masking two months – which is not a true reflection of the benefit.
include Open label, Single blind masking, and Double blind Similarly, if a trial had, for example, 800 patients, the
masking. median would be reached once 400 reached the endpoint
(e.g. experienced a particular event). But the other 400 may
Matched-pair design: A type of parallel trial design in potentially do much better, and the median value would not
which investigators identify pairs of subjects who are reflect this.
“identical” with respect to relevant factors, then randomize
them so that one receives Treatment A and the other Medical condition in easily understood language: A
Treatment B. description of the medical condition being studied in non-
medical language.
Matching: See Pairing.
Medical condition(s) investigated: Description of
Mean: The sum of the values of all observations or intended indication for the product under development.
data points divided by the number of observations; an
arithmetical average. Medical condition: The disease or a description of the
intended indication that is being investigated in the clinical
Mean difference (in meta-analysis): A method used to trial.
combine measures on continuous scales (e.g., weight),
where the mean, standard deviation and sample size in Medical device: An intervention defined as: 1. Used for
each group is known. The weight given to the difference diagnosis, cure, mitigation, treatment or prevention of a
in means from each study (e.g., how much influence each disease or condition. 2. Affects the structure and function
study has on the overall results of the meta - analysis) is of the body. 3. Does not achieve intended use through
determined by the precision of its estimate of effect. chemical reaction. 4. Is not metabolized.

Median: The middle value in a data set; that is, just as Medical monitor: A sponsor representative who has
many values are greater than the median and lower than medical authority for the evaluation of the safety aspects of
the median value. (With an even number of values, the a clinical trial.
conventional median is halfway between the two middle
values). Medical product: See Intervention.

MedDRA Classification: Medical Dictionary for Medicinal product: Synonym for therapeutic intervention,
Regulatory Activities - is a medical terminology used to but usually a drug.
classify adverse event information associated with the use Medicines and Healthcare products Regulatory Agency
of biopharmaceuticals and other medical products (e.g.,
medical devices and vaccines). (MHRA): The UK government agency responsible for
ensuring that medicines and medical devices work, and are
MedDRA Level: Key to MedDRA hierarchical levels acceptably safe.
(highest to lowest) SOC (System Organ Class) HLGT Mega-trials: Massive trials that test the advantages of
(High Level Group Term) HLT (High Level Term) PT
(Preferred Term) LLT (Lowest Level Term). therapeutic interventions by enrolling 10,000 or more
subjects. Synonym: large sample trials.
Median: Is the middle value in a set of numbers when
they are all placed in order from smallest to largest, e.g. Memorandum of Understanding (MOU): A formal
agreement between the Food and Drug Administration
the median of 5,7,9,10,13,18,23 is 10. In a clinical trial, the (FDA) and federal, state, or local government agencies;
median is reached when 50% of patients have experienced
an event (such as death or recurrence). The median academic institutions; and other entities. Note: The MOU
figure for an endpoint is normally noted with a small constitutes an understanding between the parties but is
‘m’ e.g. mPFS (median progression free-survival). Note: a nonbinding agreement. It is FDA’s policy to enter into
MOUs with other entities whenever there is a need to
It is important to remember that taking a median value define lines of authority or responsibility, or to clarify
for survival may not always provide the most accurate
picture of the effects of a treatment. For example, if 51% cooperative procedures.
of patients gain only two months or less survival benefit Messages (HL7): The atomic unit of data transferred
from a treatment while 49% gain 10 months or more, the between systems. It comprises a group of segments in a
median survival would, in fact, be calculated as less than defined sequence. Each message has a message type that

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