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Clinical SAS terms
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Clinical Study
A clinical study involves researchusing human volunteers (also
calledparticipants) that is intended to addto medical knowledge.
There are twomain types of clinical studies: clinicaltrials and
observational studies.
Clinical Trials includes bothinterventional and
observationalstudies.
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rug trials report
They are fundamental to the developmentof innovative medicines"
vaccines anddevices that treat and prevent illness.
#edicines" vaccines and devices tested butnot yet been approved
by healthauthorities.
Currently available for sale" and beingtested to $#%&'
e*isting formulations orevaluate their potential in other
diseases.
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rug development
rug discovery and development process e+ortsbegin and end with
the patient. &, e+orts areguided by two principles:
o we understand the underlying mechanism orcause of the
disease-
oes this disease represent a signicant unmetmedical need in
patients-
$f the answer to both /uestions is 0yes"0 thendevelop a research
program aimed at betterunderstanding the disease and nding
ane+ective chemical or biologic based medicine.
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rug approval process
The rst is the preclinical phase" which usuallytakes 1 to 2
years to complete. $f successful" thisphase is followed by an
application to the 3A asan investigational new drug ($4).
After an $4 is approved" the ne*t steps are clinicalphases 5" 6"
and 1" which re/uire appro*imately 5"6" and 1 years" respectively"
for completion( Table ).
$mportantly" throughout this process the 3A andinvestigators
leading the trials communicate witheach other so that such issues
as safety aremonitored.
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Continue7
The manufacturer then les a new drugapplication (4A) with the 3A
for approval.This application can either be approved or
re8ected" or the 3A might re/uest furtherstudy before making a
decision.
3ollowing acceptance" the 3A can alsore/uest that the
manufacturer conduct
additional post marketing studies. 'verall"this entire process"
on average" takesbetween 9 to 56 years.
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3A
uidance documents included under the umbrella titleof 3A
$nformation Sheets represent the agency;scurrent thinking on
protection of human sub8ects inresearch. The date following the
title of each document
represents the most recent update for that sub8ect. #any
documents were last updated prior to the
enactment of good guidance practice re/uirements.
As further updates become necessary" reformatting ofsome
documents may therefore be necessary.
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Clinical trials phase 5
%hase $ trials are the rst stage oftesting in human
sub8ects.
Testing of drug on healthy volunteersfor dose=ranging.
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%hase 6 and 1
>owever there are many phasessuch as preclinical"
phase?"5"6"1"2"and @.
%hase 6= Testing of drug on patientsto assess ecacy and
safety.
%hase 1= Testing of drug on patientsto assess ecacy and
safety.
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%hase 2 and @
%hase 2=
%ostmarketing surveillance Bwatching drug use in public.
%hase @= 3or translational research.
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Skewness
Skewness: indicator used in distribution A4ADS$S as asign of
asymmetry and deviation from a normaldistribution.
$nterpretation:
Skewness E ? = &ight skewed distribution = most valuesare
concentrated on left of the mean" with e*treme valuesto the
right.
Skewness F ? = eft skewed distribution = most values are
concentrated on the right of the mean" with e*tremevalues to the
left.
Skewness G ? = mean G median" the distribution issymmetrical
around the mean.
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Hurtosis
Hurtosis = indicator used in distribution A4ADS$S as a sign
ofIattening or 0peakedness0 of a distribution.
$nterpretation:
Hurtosis E 1 = eptokurtic distribution" sharper than a
normaldistribution" with values concentrated around the mean
andthicker tails. This means high probability for e*treme
values.
Hurtosis F 1 = %latykurtic distribution" Iatter than a
normaldistribution with a wider peak. The probability for
e*tremevalues is less than for a normal distribution" and the
valuesare wider spread around the mean.
Hurtosis G 1 = #esokurtic distribution = normal distribution
fore*ample.
