Page 33 - Terminology-Clinical-Research

past 2 years, the study’s Recruitment status is shown as Lure of initial value: What we observe [in clinical trials]
Unknown. is not so much a placebo response, but a so- called lure
of initial value, where extreme symptoms tend to get
Legal authentication: A completion status in which a spontaneously better. To get a handle on this problem, it
document has been signed manually or electronically by the would be useful to identify genes that are predictive of
individual who is legally responsible for that document. rapid disease remission, because many of our problems
in terms of testing drugs are driven by the placebo group.
Legal acceptable representative: An individual or juridical One needs very large groups to detect that small difference.
or other body authorized under applicable law to consent, on Obtaining genes predictive of response might also lead to
behalf of a prospective subject, to the subject’s participation defining the group of people who, because they are likely to
in the clinical trial.
get better spontaneously, are going to get minimal benefit
Legal representative of sponsor: An individual, company, from the drug.
institution, or organisation authorised to act on behalf of the
sponsor of a clinical trial. Must be based in the EU or the
EEA, which includes Iceland, Norway, and Liechtenstein. M
Leiter der klinischen Prüfung: Under the German Drug
Law, the physician who is head of the clinical investigation.

Life threatening adverse event/experience: Any adverse
drug experience that places the patient or subject, in the MAH: See Marketing Authorisation Holder.
view of the investigator, at immediate risk of death from Main objective of the trial: A description of the main
the reaction as it occurred (i.e., it does not include a objectives of the trial.
reaction that, had it occurred in a more severe form, might
have caused death). Mapping: In the context of representing or exchanging
data, connecting an item or symbol to a code or concept.
Ligand: A molecule that binds to another. Often a soluble Compare with translation.
molecule such as a hormone or neurotransmitter, that binds
to a receptor. Marketing Authorization Application (AMM): An
application submitted by a sponsor to the EMEA for
Listed location countries: Countries in which research approval to market a new drug (a new, non-biological
facilities for a study are located. A country is listed only molecular entity) for human use in Europe.
once, even if there is more than one facility in the country.
The list includes all countries as of the Last Updated date; Marketing Authorization Holder (MAH): The Company
any country for which all facilities were removed from the named on the Marketing Authorisation for a specific
study record are listed under Removed location countries. product in a particular country.

Logarithmic scale: A scale in which the logarithm of a Marketing Authorisation: The approval granted by the
value is used instead of the value. In a logarithmic scale on Regulatory Authority to market a specific product in a
a RevMan forest plot, the distance between 1 and 10 is the particular country.
same as the distance between 10 and 100, or between 100
and 1000. A logarithmic scale may be used when the range Marketing support trials: Clinical studies that are
of numbers being represented is large, or to represent ratios. designed to clarify therapeutic benefits of a marketed
product or to show potential decision makers the rationale
Logistic regression: A form of regression analysis that for preferring one therapy over another.
models an individual’s odds of disease or some other
outcome as a function of a risk factor or intervention. It is Markup: Computer-processable annotations within a
widely used for dichotomous outcomes, in particular, to multimedia document. Note: In the context of the HL7
carry out adjusted analysis. specification, markup syntax is according to the XML
Specification.
Longitudinal study: Investigation in which data are
collected from a number of subjects over a long period of Masking (or blinding): A clinical trial design strategy in
time (a well-known example is the Framingham Study). which one or more parties involved in the trial, such as the
investigator or participants, do not know which participants

TERMINOLOGY CLINICAL RESEARCH 33