Transcript Steps on Research Stairs

YOUR STEPS ON
RESEARCH STAIRS
Center of Excellence in Cancer
Research Tanta University
Dr. Mohamed Labib Salem, PhD
Prof. of Immunology
Director, CECR
February 16. 2015
Research?
“is to see what everybody else has
seen, and to think what nobody
else has thought"
Albert Szent-Gyorgyi, 1937 Nobel Prize; Medicine Laureate
RESEARCH
Phases of Research Skills
 Student
 Technician
 Researcher
 Scientists
 Outstanding
scientist
Research Skills
 Intellectual
skills
 Technical skills
 Expertise (experience)
‫صفات الباحث‬
‫‪ ‬االمانة العلميه‬
‫‪ ‬الجدية‬
‫‪ ‬المعاملة الحسنه‬
‫‪ ‬التعاون‬
‫‪ ‬الطموح‬
‫‪ ‬قارء ومحلل‬
‫‪ ‬التواضع‬
‫‪----- ‬‬
Research Misconduct
 Falsification
 Fabrication
 Plagiarism
Characteristic features of
research
Systematic solving of scientific problems
 Using scientific methods
 System of interconnecting phases and
steps

Steps in the Research Process
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Step I: Define the research problem
Step 2: Developing a research plan
Step 3: Collecting data
Step 4: Analysing research data
Step 5: Presenting the findings
Phases of research process
1.
2.
3.
4.
5.
Phase of concepcion
Phase of elaboration of research plan
Empiric phase
Analytic phase
Disseminative phase
Phases of research process
The research process should be understood as one of ongoing
planning, searching, discovery, reflection, synthesis, revision,
and learning.
Researchers work in
graphic form
Results
Research
Plan of research
Met hods
Aims of research
H y p o t h e s i s
Review of literature
Searching for scientific problem
I. Phase of Conception
- The phase in which content and structure of research are created
 Conceptualisation refers to the process of developing refining
abstract ideas. The activities include thinking, rethinking,
theorising, making decision, and reviewing ideas.
• It is composed of 4 steps:
1) Formulation and set bounds of research
problem, determine the purpose of study
2) Searching and review the literature related
to the research problem
3) Development of theoretical construction
of the future research
4) Creation of hypothesis
II. Phase of elaboration of
proposal and research plan
It is a general plan of research:
– selection of patients, animals, other objects used for solving
the problem: - creation of representative sample, inclusion, exclusion
criteria
– selection of the methods –qualitative, quantitative
– creation of pilot study
– selection of methods
– selection of research technology
– development a protocol of research
– to define the schedule of research
III. Empiric phase
The aim of this phase is production of results, collection
of data, and their preparation for next analysis
The results are produced by:
– experiment on animals
– by clinical study
– by using questionaire, interview, observation
– by using models - biological, electronic, mathematic....
IV. Analytic phase
The content of this phase is:
– kvantitative analysis of the data
– kvalitative analysis of the data
– statistic analysis of the data
– interpretation of the results
Methods used in analytic phase:
- corelation: looking for relationships among the two or more
values
- comparation: comparation of the result obtained in our research
with similar research done by other researchers
V. Disseminative phase
It is the phase when results of the research are
published as:
•
research report
•
lectures and posters at the congresses and
conferences
•
papers in journals ......
From an idea to a
hypothesis
: Problem
Idea? A novel thinking for
solving a problem
“All the forces in the world are
not so powerful as an idea
whose time has come”
Victor Hugo
Think globally and apply locally
Coming up with a bright
IDEA!

Does it test a hypothesis or a concept?
• Has it or a similar study been done before?
• Is it important and make a difference?
• Does it fill a gap in knowledge or lead to a greater
understanding?
• Has it or a similar study been done before?
• Does it worth to spend considerable time thinking,
reading and doing?
• Does it fit the focus of my organization, my
department, institution, and profession?
Question your Idea
• Is it based on your preliminary data?
• Is it based on your own observations?
• Is it based on your reading?
• Is it based on others’ expertise?
• Is it descriptive?
• Is it mechanistic?
• Is it translational?
Hypothesis
State it after you present the problem
 Provide the solution for a specific
problem.
 It indirectly expresses the goals
(SPECIFIC AIMS).
 It should be testable.
 Funnel the reader to the hypothesis – at
the end of the background/significance
section

Prof. Mohamed Labib Salem, PhD
Competitive Project Unit (CPU), Tanta University
Hypothesis

Formalized hypotheses contain two
variables
One is "independent" and the other is
"dependent."
The independent variable is the one
you, the "scientist" control
the dependent variable is the one that
you observe and/or measure the
results.
The 5 W + H: Proposal Railway
1.
2.
3.
4.
What (Problem)
Why (Significance)
Who (PI and Co-PIs)
Where (Facility)
why
5. When (Time Line)
+ How (Methods)
why
why
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The Application of the
Scientific Method:
Preclinical Trials
Copyright 2010. PEER.tamu.edu
Phases of Research From Bench
to Clinic
Preclinical
Studies
In vitro
models
Clinical BENCH
studies
Phase I study
Phase II study
Industry
(Market)
Phase III study
Pre-Clinical Trials and
Clinical Trials

Are the processes by which scientists test
drugs and devices to see if they are SAFE
and EFFECTIVE.
What is a Preclinical Trial?

Preclinical trial - a laboratory test of a new
drug or a new medical device, usually done
on animal subjects, to see if the hoped-for
treatment really works and if it is safe to test
on humans.
There are two types of Research:
Basic and Applied
Basic Research: discovering new facts about how
things work, how they are made, or what causes a
biological event to occur. Basic research can
explore a topic, explain a topic or describe a topic.
For Example: A researcher discovered that genes
can be turned off or on by small RNA molecules in
the body. This study was conducted on worms. It
led to the Nobel Prize in 2006.
“Basic” vs. “Applied”
Research
Applied Research: Taking the
information discovered in basic
research and investigating how to
use it to treat and prevent
sicknesses.
Example: A researcher uses the
information about turning genes
off and on to find a drug that is
used to turn off genes that cause
diseases and disorders in humans.
Segment of DNA.
Many such
segments act as
genes.
Where Do We Get New Ideas For
Research?
Ideas come from all kinds of scientists and medical
professionals who do research in universities, government
labs, and in corporations.
Take a Minute to Discuss:

What is a Pre-Clinical Trial?

What is the difference between basic
research and applied research?

What sickness or disease would you like to
see an effective treatment for?
There are several steps involved
with doing a Pre-Clinical Trial:
5
File for approval as an Investigational New
Drug (IND)
4
Establish Effective and Toxic Doses
3
Screen the Drug in the Assay
2
Develop a Bioassay
1
Indentify a Drug Target
Steps in Doing a
Pre-Clinical Trial:
Step One: Get an idea for a
drug target.
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Drugs usually act on either cellular or genetic
chemicals in the body, known as targets,
which are believed to be associated with disease.
Scientists use a variety of techniques to identify
and isolate individual targets to learn more about
their functions and how they influence disease.
Compounds are then identified that have various
interactions with the drug targets that might be
helpful in treatment of a specific disease.
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Drugs target specific points in biochemical
pathways
Biochemical pathways are series of chemical
reactions occurring within a cell. In each pathway, a
principal chemical is modified by chemical reactions.
Examples of different types of biochemical pathways:
A
A
E
B
D
C
B
C
D
E
Any step in the pathway, for
example from A to B, or B to C,
might be a target for the right
drug.
*
See slide
note
Steps in Doing a
Pre-Clinical Trial:
Step Two: Develop a Bioassay
A Bioassay is a “live” system that can be
used to measure drug effect.
It may be a culture of cells or
organs or a whole animal.
For example:
 Zebra-fish embryos - you
can see effects of drugs on
bone density, blood vessel
growth and many other
systems of the zebra-fish.

Steps in Doing a
Pre-Clinical Trial:
Step Three: Screen the
drug in the Bioassay.

This is the actual test of the
drug on the chosen bioassay.

This will determine if the drug
is SAFE and if it is EFFECTIVE
in the bioassay (BEFORE it is
ever tested on humans!)
Steps in Doing a
Pre-Clinical Trial:
Step Four: Establish what dosage
amount of the drug is safe and what
dosage amount of the drug is toxic.

Most drugs have a toxic level or an amount at
which the drug will become
harmful instead of helpful.
Steps in Doing a
Pre-Clinical Trial:
Step Five: Application is made to the
Food and Drug Administration (FDA)
as an Investigational New Drug (IND).
IND must show how the drug:
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Is manufactured.
Appears (color, solubility, melting point,
particle size, moisture content).
Formulated (pills, liquid, etc. + inactive ingredients).
Will be analyzed for purity, concentration, stability.
Will be tested for safety (this will be the basis for
allowing first use in humans).
Review: Steps to New Drug Discovery
Pre-Clinical Trials
Get idea for drug target
Develop a bioassay
Screen chemical compounds in assay
Establish effective and toxic amounts
File for approval as an Investigational New
Drug (IND) (leads to clinical trials)
ETHICAL REGULATIONS AND
STANDARADS
We have to be
cared for
properly.
It’s the law!!!!!!!
The Three Rs
•
The Three R’s are principles
of good science that scientists
must adhere to when
conducting animal-based
research.
Project Anatomy
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Abstract
Introduction
Background
Oobjectives
Experimental Design
Methods
Facilities and Equipments
Budget
References
Appendices (any additional documents)
‫خطوات استراتيجية حل المشكالت‬
‫الملخص‪ :‬خطة العمل‬
‫‪ ‬تحديد مجال البحث‬
‫‪ ‬القراءة حول نقطة البحث‬
‫‪ ‬ايجاد مشرف من المتخصصين‬
‫‪ ‬تحديد المشكلة واسبابها‬
‫‪ ‬طرح فكرة هل المشكلة‬
‫‪ ‬البحث عن المساعدين‬
‫‪ ‬كتابه المشروع‬
‫‪ ‬تقديمه للجهة المنحة‬
‫«حنن أطفال نلعب عيل شاطئ العمل «‬
‫أينش تاين‬
Good luck
E-mail:
[email protected]
Tel. 01274272624