Page 37 - Terminology-Clinical-Research

include the patient in the study. No additional diagnostic or Number of sites anticipated in the EEA: Number of
monitoring procedures shall be applied to the patients and investigator sites in the European Economic Area where the
epidemiological methods shall be used for the analysis of trial is planned to take place.
collected data.
Number of sites anticipated outside of the EEA: Number
Normal distribution: A statistical distribution with known of investigator sites outside the European Economic Area
properties commonly used as the basis of models to analyze where the trial is planned to take place.
continuous data. Key assumptions in such analyses are that
the data are symmetrically distributed about a mean value, Number of treatment arms in the trial: Any of the
and the shape of the distribution can be described using the treatment groups in a randomized trial. Most randomized
mean and standard deviation. trials have two “arms,” but some have three “arms,” or even
more.
Not approved letter: An official communication from
FDA to inform a sponsor of a marketing application that Nuremberg Code: Code of ethics, set forth in 1947, for
the important deficiencies described in the letter preclude conducting human medical research.
approval unless corrected.
Nuremberg Code – Directives for Human
Not yet recruiting: The clinical study has not started Experimentation: 1. The voluntary consent of the human
recruiting participants. A type of recruitment status. subject is absolutely essential. This means that the person
involved should have legal capacity to give consent; should
Notified Body (NB): A private institution charged by be so situated as to be able to exercise free power of choice,
the Competent Authority with verifying compliance of without the intervention of any element of force, fraud,
medical devices (not drugs) with the applicable Essential deceit, duress, overreaching, or other ulterior form of
Requirements stated in the Medical Device Directive. constraint or coercion; and should have sufficient knowledge
This process, called Conformity Assessment, has EU-wide and comprehension of the elements of the subject matter
validity once completed by the NB. involved as to enable him to make an understanding and
enlightened decision. This latter element requires that
Null hypothesis: The assertion that no true association or before the acceptance of an affirmative decision by the
difference in the study outcome or comparison of interest experimental subject there should be made known to him
between comparison groups exists in the larger population the nature, duration, and purpose of the experiment; the
from which the study samples are obtained. Note: A null method and means by which it is to be conducted; all
hypothesis (for example, “subjects will experience no inconveniences and hazards reasonable to be expected; and
change in blood pressure as a result of administration of the the effects upon his health or person which may possibly
test product”) is used to rule out every possibility except the come from his participation in the experiment. The duty
one the researcher is trying to prove, and is used because and responsibility for ascertaining the quality of the consent
most statistical methods are less able to prove something rests upon each individual who initiates, directs or engages
true than to provide strong evidence that it is false. The in the experiment. It is a personal duty and responsibility
assertion that no true association or difference in the study which may not be delegated to another with impunity. 2.
outcome or comparison of interest between comparison The experiment should be such as to yield fruitful results
groups exists in the larger population from which the study for the good of society, unprocurable by other methods or
samples are obtained. means of study, and not random and unnecessary in nature.
3. The experiment should be so designed and based on the
Number needed to treat (NNT): The NNT is a statistic that results of animal experimentation and a knowledge of the
tells the actual number of patients who would need to be natural history of the disease or other problem under study
treated with a given therapy (or combination of therapies) that the anticipated results will justify the performance of
for one patient to get a particular endpoint benefit. The NNT the experiment. 4. The experiment should be so conducted
is calculated from clinical study data and is considered a as to avoid all unnecessary physical and mental suffering
useful measure for deciding if a treatment benefits a large and injury. 5. No experiment should be conducted where
number or just a small number of patients given a drug. The there is an a priori reason to believe that death or disabling
lower the NNT the more effective the treatment.
injury will occur; except, perhaps, in those experiments
Number of sites anticipated in Member State concerned: where the experimental physicians also serve as subjects.
This is number of sites in the Member State concerned 6. The degree of risk to be taken should never exceed that
where the trial will take place. determined by the humanitarian importance of the problem

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