CLINICAL TRIALS : TYPES AND DESIGN
CONTENTS
INTRODUCTION
TYPES
PHASES OF CLINICAL TRIALS
DESIGN OF CLINICAL TRIALS
CLINICAL TRIALS
Clinical trials are a type of research that
studies new tests and treatments and
evaluates their effects on human health
outcomes.
People volunteer to take part in clinical trials
to test medical intervention including drugs ,
cells and other biological products, surgical
procedures, radiological procedures, devices,
behavioural treatments and preventive care.
TYPES OF CLINICAL TRIALS
• By the purpose of trials-
Treatments trials
Prevention trials
Early- detection trials
Diagnostic trials
Quality-of-life study or supportive care studies.
• Based on researcher behave
Observational study
Interventional stydy
PHASES OF CLINICAL TRIALS
DESIGN OF
CLINICAL TRIALS
OBSERVATION EXPERIMENTL
STUDY STUDY
COHORT RCT
STUDY
CASE NON RCT
CONTROL
CROSS
SECTIONAL
STUDY
PARALLEL DESIGN
50
GROUP A 25 GROUP B 25
NEW DRUG REFRENCE
DRUG/PLACEBO
A parallel study is a type of clinical study where treatment and control
are allocated to different individuals.
In this two group of treatments, a and b, are given so that one
Group receives only a while another group receives only b.
CROSS OVER DESIGN
GROUP 25 GROUP 25
New drug Std.drug
In these types of studies each patient server as his own control.
each patient gets both treatments
Each patient receive first treatment than wash out time is provided
than other treatment is provided to the same .
CROSS –OVER DESIGN
Subject First Second Third Fourth
1 A B C D
2 B C D A
3 C D A B
4 D A B C
FACTORIAL DESIGN
Studies involving two or more factors while
randomizing are called factorial .
Factorial design patient researchers to
invastigate the joint effect two or more factors
on a dependent variable.
Used when it is desired to study the influence of
a no. of factors on the treatment compared as
well their interaction with differents treatments
factors on a dependent variable design.
ADAPTIVE TRIAL DESIGN
An adaptive design allows modification/
adaptation to trial and or statistical procedure
of on going clinical trials .
Major adaptation of trial or statistical
procedure of on going trials may results in a
totally different trials that is unable to
address the scientific or medical question the
trials intends to answer.
NON RANDMIZED CLINICAL TRIALS
It is also known as Quasi- experimental
designs.
In non randomly assigned control group
studies, at least two separate groups are
evaluated.
One of which receives the intervention of
interest and another that serves as a control or
comparison group.
MATCH PAIR DESIGN
In a match pair design, participants are
grouped into pairs based on certain
characteristics (e.g., age, gender, disease
severity) that are believed to be important for
the outcome of the trial.
Once pairs are formed, one member of each
pair is randomly assigned to one treatment
group, while the other member is assigned to
the other treatment group.
Match pair design
1 12 25 3 9 32
FEMALE FEMALE MALE MALE
D(A) D(B)
21YR 21 YR 24 YR
Stratification design
Male 25 Female 25 Age 50(<20%) Age 50 (>20%)
Group A Group B
(50) (50)
In the design select the population on the basis of strata like age ,
gender .
Eg:- select from male (5), female (5), age<20 (5), age >20 (5).
Stratification design
Stratified design, also known as stratified sampling or
stratification, is a research methodology used to ensure that
different subgroups within a population are adequately
represented in a study.
In a stratified design, the population is divided into distinct
subgroups, or strata, based on certain characteristics that are
relevant to the research question.
Once the population is divided into strata, researchers then
randomly select participants from each stratum.
