Research Methodology

Types of Research
Cletus J.M.D’Souza
Department of Biochemistry
Manasagangotri
Mysore
 What is research?

• We ask questions all the time

• Research is a formal way of going
about asking questions
 The purposes of research

• Description (fact finding)

• Exploration (looking for patterns)
• Analysis (explaining why or how)
• Prediction (forecasting the likelihood of particular events)
• Problem Solving (improvement of current practice)
 Types of Research

• Basic research
• Applied Research
 Motivations for Research
• ‘Basic research'
‘because it’s there’
contribute to abstract, theoretical
understanding
• ‘Applied research'
‘I have hammer, so find a nail’
‘I have problem, so find a solution’
“The formulation
of the problem is
often more
essential than its
solution”

Albert Einstein
 Research Design
• You can get the answer
from different routes
• You choose the route you
are going to follow
• Is it experimental
• is it survey
• Is it a cohort study
• Is it meta analysis
• Is it bioinformatics
• Or a little of everything
 Basic or Applied Research
• Experimental Research
Experiments with Plants, animals,
microbes, humans, nature, ecosystem, and so
on..
• Observational Research
from what is already published, or re-
examining published work with newer
perspectives
 Classifications of Research Studies:
Three Main Types
Observational Studies:
• Groups are studied & contrasts made between groups
• The observed data collected are analyzed
Analytic Studies:
• Also called Experimental
• Study the impact of a certain therapy
• Ultimately the investigator controls factor being studied
Clinical Trial:
• Considered the “true” experimental study
• “Gold Standard” of clinical research
• Often a prospective study that compares the effect and value
of an intervention against a control in human subjects
NY/VI AETC
Choosing the right study design
An early Clinical Trial (N = 2)
In the late 18th century, King Gustav III of
Sweden decided that coffee was poison and
ordered a clinical trial.

Ann Intern Med 1992;117:30

Study design

- The king condemned a convicted

murderer to drink coffee every day.
- Control: another murderer was
condemned to drink tea daily.
- Outcome: death.
- Two physicians were appointed to
determine the outcome.
Results
- The two doctors died first.
- The king was murdered.
- Both convicts enjoyed long life until the
tea drinker died at age 83 (no age
was given for the coffee drinker).
Discussion

One should not rely on such a small

sample size.

The outcome of the trial had no effect

on the decision makers.

Coffee was forbidden in Sweden in

1794 and again in 1822.
Conclusions
None possible.

External events and other biases may

have confounded the result.

Rulers should not mess with

clinical trials.
 How do you hit upon a research idea?
From literature
survey

From knowledge of
Other sources? IDEA metabolic pathways

From Traditional
Knowledge
 How to Develop the Idea

In vitro

Mechanism
Idea Proof of Concept
of Action

In vivo
 Specific Proposal for Research
Plants are very popular…
• Select 6 plants
• Make 6 extracts
• Test 6 biological properties
• Try to isolate some compound
• Try to identify structure of some molecule
 What to do when someone else
wants to do research?
• Select newer plants !!!

• Same can be true for microorganisms…

• Or diseases…Diabetes…Cancer….
“Screening, Isolation and characterization of
antidiabetic components from Indian medicinal
plants”
Normal study would be…
• Take some plants reported as anti diabetic
• Make an extract
• Test inhibition of some enzymes- α amylase, sucrase, α
glucosidase…
• Streptozotocin diabetic rats
• Test for lowering of blood glucose
• END of study..
 How can this study be made
Novel?
• Look for mechanism of insulin release
• GLP-1 (Glucagon –like peptide-1)
• Receptor mediated action
• Look for GLP-1 agonists
• Or DPP-4 inhibitors
• You have a project no one has done before…
Research Studies
• Many classified as “Epidemiological
Studies”

Epidemiology often is defined as:

The study of the distribution of a disease or
condition in a population and the factors
that influence that distribution.
Clinical Research
Methods

Meta-
Analysis

Systematic
Review

Randomized
Controlled Trial

Cohort Study

Case Control Study

Observational Studies

Dominate the literature

Funai et al.
Distribution of study designs
in four major US journals ......
Gynecol Obstet Invest 2001;51:8-11
 THE LANCET 2002;359:57- 61

Algorithm for
classification of
types of clinical
research

Exposure Outcome
Oral contraceptives
Ovarian cancer
 Ovarian cancer
Use of oral contraceptives
Control group
Choosing the right study design
 …... several famous
large cohort studies continue to
provide important information …..
Framingham Heart Study 1948
United Kingdom Prospective Diabetes study 1977
 Cohort studies
Intuitive approach to studying disease
incidence and risk factors:
1. Start with a population at risk
2. Measure characteristics at baseline
3. Follow-up the population over time with
a) surveillance or b) re-examination
4. Compare event rates in people with and
without characteristics of interest

10/1/2001 Cohort studies 33

 Cohort studies
Can be large or small
Can be long or short
Can be simple or elaborate
Can be local or multinational
For rare outcomes need many people and/or
lengthy follow-up
May have to decide what characteristics to
measure long in advance
Why Cohort studies

•Life’s a journey. . .
•We each carry the
burden of personal and
group risk factors and
exposures.
• we hope to identify
those characteristics
causing disease.
Why Cohort studies
•Life’s a journey. . .
•In individuals, the only way
to know if a risk factor
caused disease would be to
find an exact double, living
in ain every way to the
exposed subject--except for
the exposure. parallel
universe, identical
Why Cohort studies
•Life’s a journey. . .
•If only the exposed
subject developed
disease, we could be
certain the exposure
was causal.
Why Cohort studies
•Life’s a journey. . .
•The best we can do is
compare populations that
are similar (not identical) in
everything except the risk
factor.
•If we see increased disease
only in the group with the
risk factor, we can suspect
that the risk factor caused
the disease.