YOUR STEPS ON RESEARCH STAIRS

Center of Excellence in Cancer Research Tanta University

February 16. 2015

Dr. Mohamed Labib Salem, PhDProf. of ImmunologyDirector, CECR

Search Versus 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?

RE

SE

AR

CH

Phases of Research Skills

StudentTechnicianResearcherScientistsOutstanding scientist

Research Skills

Intellectual skillsTechnical skillsExpertise (experience)

الباحث صفات العلميه االمانة الجدية الحسنه المعاملة التعاون الطموح ومحلل قارء التواضع-----

Research Misconduct

Falsification

Fabrication

Plagiarism

Systematic solving of scientific problems

Using scientific methods System of interconnecting phases

and steps

Characteristic features of research

4

Copyright © 2002 by The McGraw-Hill Companies, Inc. All rights reserved.

Steps in the Research Process

● 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

8-3

1. Phase of concepcion2. Phase of elaboration of research

plan3. Empiric phase4. Analytic phase5. Disseminative phase

Phases of research process

Phases of research process

The research process should be understood as one of ongoingplanning, searching, discovery, reflection, synthesis, revision,

and learning.

Researchers work in graphic form

Searching for scientific problem

Review of literature

H y p o t h e s i s

Aims of research

M e t h o d s

Plan of research

Research

Results

- 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

I. Phase of Conception

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

“All the forces in the world are not so powerful as an idea whose time has come”

Victor Hugo

Think globally and apply locally

Idea? A novel thinking for solving a problem

Does it test a hypothesis or a concept?

• Does it fit the focus of my organization, my department, institution, and profession?

• 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?

Coming up with a bright IDEA!

• Is it translational?

• 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?

Question your Idea

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.

Hypothesis

The 5 W + H: Proposal Railway

1. What (Problem)

2. Why (Significance)

3. Who (PI and Co-PIs) why4. Where (Facility)

why5. When (Time Line)

+ How (Methods)why 29

The Application of the Scientific Method: Preclinical Trials

Copyright 2010. PEER.tamu.edu

Phase II study

Phase III study

In vitro models

Preclinical Studies

Phase I study

Industry

(Market)

BENCH

Phases of Research From Bench to Clinic

Clinical studies

Are the processes by which scientists test drugs and devices to see if they are SAFE and EFFECTIVE.

Pre-Clinical Trials and Clinical Trials

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:

File for approval as an Investigational New Drug (IND)5

4

3

2

1

Establish Effective and Toxic Doses

Screen the Drug in the Assay

Develop a Bioassay

Indentify a Drug Target

Steps in Doing aPre-Clinical Trial:

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.

Step One: Get an idea for a drug target.

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

E B

D C

A 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

Step Two: Develop a BioassayA 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 aPre-Clinical Trial:

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 aPre-Clinical Trial:

Step Three: Screen the drug in the Bioassay.

Most drugs have a toxic level or an amount at which the drug will becomeharmful instead of helpful.

Steps in Doing aPre-Clinical Trial:

Step Four: Establish what dosage amount of the drug is safe and what dosage amount of the drug is toxic.

IND must show how the drug: 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).

Steps in Doing aPre-Clinical Trial:

Step Five: Application is made to the Food and Drug Administration (FDA) as an Investigational New Drug (IND).

Review: Steps to New Drug DiscoveryPre-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.

Abstract Introduction Background Oobjectives Experimental Design Methods Facilities and Equipments Budget References Appendices (any additional documents)

Project Anatomy

المشكالت حل استراتيجية خطوات

العمل: خطة الملخص البحث مجال تحديد البحث نقطة حول القراءة المتخصصين من مشرف ايجاد واسبابها المشكلة تحديد المشكلة هل فكرة طرح المساعدين عن البحث المشروع كتابه المنحة للجهة تقديمه

» نحن أطفال نلعب علي شاطئ العلم» أينشتاين

Moh

amed

L.

Sale

m

Good luck

E-mail: mohamedlabibsalem@yahoo.comTel. 01274272624