BIOSTATISTICS

DEFINITION

Biostatistics is the collection, arrangement,

analysis and interpretation of mathematical facts or data with special reference to studies of
Health and Social Problems
IMPORTANCE

Used in Research

Assess results of Clinical Trials

Assess new treatment strategies; new drugs

To find the cause of a certain disease or condition

CLINICAL TRIALS IN PHARMACOLOGY

THESE ARE USED TO TEST THE EFFECTIVENESS OR OTHER CHARACTERISTICS OF A

DRUG FOR A PARTICULAR CONDITION
ALSO A NEW TREATMENT (DRUG) MAY BE COMPARED WITH AN OLD TREATMENT (DRUG)
IMPORTANT TERMINOLOGY IN CLINICAL TRIALS
SAMPLES (TEST AND CONTROL)
SAMPLE SIZE
VARIABLE(S)
CONSENT
PLACEBO
PROSPECTIVE STUDY
RETROSPECTIVE STUDY
BIAS
SINGLE BLINDED STUDY
DOUBLE BLINDED STUDY
PRESENTATION OF DATA (E.G FROM CLINICAL TRIALS)
PICTORIAL DESCRIPTION
BAR GRAPHS, HISTOGRAMS
FREQUENCY TABLES
PIE CHARTS, PICTOGRAMS
QUANTITATIVE DESCRIPTION
MEASURES OF CENTRAL TENDENCY

MEAN (AVERAGE)
SUM OF ALL THE READINGS DIVIDED BY THE NUMBER OF READINGS
MEAN = SUM OF ALL INDIVIDUAL OBSERVATIONS
NUMBER OF OBSERVATIONS

M () = X
n

= SUM OF
X= INDIVIDUAL OBSERVATIONS
n = NUMBER OF OBSERVATIONSMEASURES OF VARIABILITY
THESE DESCRIBE THE SPREAD OF DATA FROM THE MEAN VALUE
1. RANGE
2. VARIANCE
Variance () or S2=
INCLUDEPICTURE http://onlinestatbook.com/chapter3/graphics/sample_var.gif *
MERGEFORMATINET

a) FIND THE DEVIATION OF EACH READING FROM THE MEAN

b) SQUARE ALL THESE DEVIATIONS
c) ADD ALL THESE SQUARES UP
d) DIVIDE BY THE SAMPLE SIZE MINUS ONE

S. No SYSTOLIC BP MEAN DIFFERENCE FROM MEAN D2 SUM OF D2 1 110 +5 25 2 100

-5 25 3 105 105 0 0 100 4 100 -5 25 5 110 +5 25
Variance = (X M)2
n-1

Variance = 100
4
STANDARD DEVIATION (SD)

SD IS THE UNDER ROOT OF THE VARIANCE

SD = Variance
The Standard Deviation Formula
INCLUDEPICTURE http://www.mathmotivation.com/images/std-dev-formula.gif *
MERGEFORMATINET
In this formula, x is the value of the mean, N is the sample size, and xi represents each data
value from i=1 to i=N..- The symbol indicates that you must add up the sum-(x1 - x)2 + (x2 - x)2 +
(x3 - x)2 + (x4 - x)2 + (x5 - x)2. . . +- (xN - x)2
Standard deviation is the is defined as the average amount by which values in a distribution differ
from the mean
SHAPE* MERGEFORMAT

STANDARD ERROR OF THE MEAN (SEM)

THIS IS THE POSSIBLE DEVIATION OF THE

MEAN FROM ITS TRUE VALUE
USED TO COMPARE THE MEANS OF
CONTROL AND EXPERIMENTAL GROUPS
THIS INDICATES THE RELIABILITY OF THE SAMPLE SIZE AS REPRESENTING THE MEAN
OF THE POPULATION FROM WHICH THE SAMPLE SIZE WAS DRAWN
SEM = SD
n
PROBABILITY & P-VALUE

Everyday concepts of likelihood, predictability, chance and certainty are formulized by branch of
mathematics called probability

PROBABILITY IN BIOSTATISTICS IS TAKEN AS THE P VALUE, WHICH IS TAKEN OUT OF

100%.
A P VALUE OF LESS THAN 0.05 MEANS PROBABILITY OF LESS THAN 5% AND THIS IS
TAKEN AS STATISTICALLY SIGNIFICANT (THERE IS A DIFFERENCE BETWEEN THE TWO
DRUGS AND IT IS NOT DUE TO CHANCE)
A P VALUE EQUAL TO OR ABOVE 0.05 IS TAKEN AS STATISTICALLY INSIGNIFICANT
STUDENTSt TEST
ONE OF THE TESTS USED TO FIND THE P VALUE HENCE TO DETERMINE THE
STATISTICAL SIGNIFICANCE OF CLINICAL DATA
t = M1 M2

S.E.M A + S.E.M B

SEM A SEM B ARE VALUES OF STANDARD ERROR OF MEAN OF GROUPS A B

THE VALUE OF t OBTAINED IS THEN USED TO OBTAIN THE P VALUE FROM t TABLES
IT IS SEEN THAT GREATER THE VALUE OF t, THE SMALLER THE VALUE OF P
IT IS WRITTEN AS tP(n-1) , FOR EXAMPLE, FOR 8 SUBJECTS, t0.5 (7) = 2.04
IF THE CALCULATED VALUE OF t IS MORE THAN THE TABLE VALUE OF t (FOR P VALUE
OF 0.05), IT MEANS THAT THE MEANS OF THE TWO GROUPS (A AND B) IS STATISTICALLY
SIGNIFICANT VICE VERSA
INTERPRETATION OF STATISTICAL INFERENCE

This is the last step in biostatistical analysis. To test statistical hypothesis two presumptions are
made.

Null Hypothesis:
(Ho) also called hypothesis of no differences. It nullifies the claim that experiments results differ
from the one observed already.

Alternate hypothesis:
(HA) also called hypothesis of significant difference. It states that the sample result is different
(greater or smaller) from the hypothetical value of population.
Various tests are performed to accept or reject the null hypothesis (like t test above)

EXAMPLE
1. MAKE A NULL HYPOTHESIS E.G. THERE IS NO DIFFERENCE BETWEEN THE SYSTOLIC
BP OF BOYS AND GIRLS

2. FIND OUT IF THIS NULL HYPOTHESIS IS TRUE OR FALSE BY OBTAINING P VALUE

FROM t TEST

3. IF P VALUE IS LESS THAN 0.05 NULL HYPOTHESIS IS REJECTED AND ALTERNATE

HYPOTHESIS IS ACCEPTED

4. IF P VALUE IS MORE THAN 0.05, NULL HYPOTHESIS IS ACCEPTED ALTERNATE

HYPOTHESIS IS REJECT
EXPERIMENT:
TO DETERMINE THE STATISTICAL SIGNIFANCE OF SYSTOLIC BP READINGS IN TWO
GROUPS OF STUDENTS

PROCEDURE:

STUDENTS ARE DIVIDED INTO DIFFERENT GROUPS. EACH GROUP IS FURTHER DIVIDED
INTO 2 GROUPS (A AND B)
SYSTOLIC BLOOD PRESSURE OF ALL STUDENTS IS TAKEN AND NOTED DOWN
STATISTICAL SIGNIFICANCE OF DIFERENCE IN SYSTOLIC BP OF GROUPS A AND B IS
DETERMINED BY TAKING MEAN, SEM OF BOTH GROUPS, APPLYING t TEST FORMULA
AND FINDING THE CORRESPENDING P VALUE FROM t TABLES

INFERENCE

IF P VALUE IS LESS THAN 0.05 THERE IS A STATISTICAL DIFFERENCE IN SYSTOLIC BP

BETWEEN THE TWO GROUPS A AND B

IF P VALUE IS MORE THAN 0.05 THEN THERE IS NO STATISTICAL DIFFERENCE BETWEEN

THE TWO GROUPS
EXPERIMENT:
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