In this presentation you will understand what is clinical trial and design of clinical trial with their relevant example. types of design used according to the nature of study

1. CLINICAL TRIAL
DESIGNS
ANURAG PANDEY
M.SC CLINICAL RESEARCH

2. CONTENT:
 What is clinical trials
 Importance of clinical trials
 Classification of clinical trials
 Types of clinical trial designs
 Conclusion

3. Clinical Trials
Clinical trials are research studies, which is ethically
preformed with help of human volunteers that are aimed
at evaluating a medical, or surgical intervention.
This is primary way that researchers find out if a new
treatment like new drug, or medical device like
(pacemaker, pregnancy test kits) is safe and effective in
people.

4. Importance of Clinical Trials:
 Discovering medical science  Easy to understand
 Makes an impact  Safety & toxicity of drug
 To improve of quality
care

5. Classification of Clinical Trials :

6. Types of Clinical Trial Design:
Some of the most significant clinical trial designs given below:
PARALLEL GROUP
DESIGN
CROSS-OVER DESIGN
MATCHED PAIR DESIGN
FACTORIAL DESIGN
ADAPTIVE DESIGN
DESCRIPTIVE DESIGN
COHORT DESIGN
GROUP SEQUENTIAL
DESIGN

7. Parallel Group Design
 A parallel group design is a complete randomizes design.
 It compares two groups.
Example: a person might receive an injection of saline
solution instead of the experimental drug.

8. Match Pair Design
 This design is used to compare only two interventions.
 Participants are grouped into pairs, based on some
variables like:
• Age
• Sex
• Weight etc.
 Within each pair participants are
randomly assigned to different treatments.
Example: A 25-year-old male will
be paired with another 25-year-
old male.

9. Pros And Cons Of Matched Pair
Design
Pros Cons
 It is simple and
easy to implement.
 If one participant
drops out you lose
two persons data.
 It is universally
acceptable
 Participants can’t be
matched on every
level.
 It is applicable to
acute condition.
 Matching is difficult
and time consuming.

10. Cross-Over Design
 It is a modified randomized block design in
which each group receives more than one
treatment at different time period.
 Williams Design & Split Person Design is a
sub types of cross-over design.
Washout period: the time frame allotted for an
administered drug to be eliminated from the body.

11. Williams Design Split Person Design
In this design more than
two treatments
to be compared.
In this design two
interventions administer at
the same time in two
different part of body
it is sub types of cross over
design.
Interventions are given on
opposite half poof body.
Possible pairs are ACB,
BAC,& CBA
Used in dermatology.

12.  Pros Cons
 Smaller sample size  Drop-outs can be
higher
 Patient get both the
treatment
 Order of drug
administration can
affect the outcome
 Drug with short life  Time consuming
 Short treatment period  Sequence effect
 Chronic disease  Period effect
Pros & Cons of Cross-over Design

13. Factorial Design
 It is use to test the effect
of two or more treatment
simultaneously by using
different combination of
the treatments.
 This combination can be
either A or B, A & B, and
neither of them.

14. Pros Cons
 Two interventions can
be studied in the
same trial without
increasing the
number of
participants.
 Difficult to analyze
 Required large no. of
subject.

15. Adaptive Design
 An adaptive design is defined as a design that
allows modifications to the trial or procedures
of the trial after its initiation without
undermining its validity and integrity.
 Due to flexibility this designs are also termed
as “flexible designs.”

16. Descriptive Design
 It is observational, survey case study design that aims
to obtain information & systematically describe a
phenomenon, situation, or population.
 Purpose: Observe, describe, and document aspect of
situation as occurs naturally.
 To gain more information regarding characteristics
within a single trial.
Use:
• To Compare Variables
• To Define the
Characteristics of Subject

17. Univariant Comparative
 This design does
not focus on the
study of a single
variable; there are
may be one or
more variables
involved in the
study
 Comparing two
investigational
product
 Example:
Metformin vs.
Vildagliptin +
pioglitazone
hydrochloride
 It is classified into following types:

18. Group Sequential Design
 It is an adaptive design. It is an example of a
Phase III trial with rules for early stopping for
safety & efficacy.
 In this design , depending upon the interim
results trial can be stopped prematurely, if
there are safety or efficacy issues and
additional modifications can be made like dose
adjustment.

19. Pros Cons
• Drug and medical devices
may get to market faster.
• Study subject included in
interim analysis are also
included in final data
analysis.
• Waste of time and resource
can be minimized if device
or treatment are not
effective.
• Violates the one person
one vote rule that ensures
independence of
estimates.

20. Correlational Design
 It is a type of observational study design.
 Examining relationship between two or more
variables in a natural setting without
manipulation or control (bias).
 Ex; A correlational study on the effect of
smoking on lung cancer.
 It is classified into two types;
• Prospective
• Retrospective

21. Prospective Design Retrospective Design
 It is a type of cohort
study, or group
study, where participants
are enrolled into the
study and their outcomes
will be recorded
 Here researchers relates
the present to the future.
 It is a type of cohort study
where the data is collected
from the past studies.
 Here researches links the
present events with past
events.
Ambispective Design
 This is very special kind
of study where the
observations are
bidirectional (pat and
future both) from the
time point it begins.

22. Conclusion
• Clinical trial design differs based on
requirement of the study and type of
study.
• There are some other clinical trial design
that are present and practiced; above
given are the most significant in clinical
research