A very comprehensive, crisp, lucid presentation introducing the basics of Clinical research. Globally recognized scientists: 1) Louis Pateur: a. French chemist and microbiologist b. principles of vaccination, microbial fermentation, and EPONYMOUS process of Pasteurization c. Integral Part of our everyday life d. germ theory of disease e. cure for anthrax, rabies 2) Charles Darwin a. Angry with his father Bent on proving our forefathers were monkeys b. Descent of Man c. Natural selection d. Evolution Slide 5 1. FINER criteria for research topic: a. Feasible b. Interesting c. Novel does not necessarily mean that the research has not been done before. The prefix “re” in the word research implies searching again add to the existing body of knowledge d. Ethical justification e. Relevant Slide 6 3) History: a. Book of Daniel b. King Neba-ka-nezzar c. Wine & meat d. Daniel & 3 fellows Legume + water diet x 10 days 4) Avicenna (10th AD) 5) Concept paper 1 paper document Slide 9 1. Cohort Prospective, retrospective SMART criteria: a. Specific b. Measurable c. Achievable d. Realistic e. Time-bound Slide 12 1. What to do: Hypothesis generation 2. Why did I begin: Intro 3. What did I do Methodology 4. What did I find: Results 5. What it means Discussion b. Abbreviations: a. IP- Investigational Product

1. For M.G.M. PG Orientation Program

2. Why do Research? (1/3)
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3. Why bother? (2/3)
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4. Why ME? (3/3)
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5. Clinical Research
• any investigation in human
participants designed to discover or
verify:
• clinical effects
• pharmacologic effects
• and/or ADR of an IP
• identify S & E considerations of an IP
used to prevent, diagnose, treat, or
modify disease or other health-related
conditions
WHO definition:
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FINER criteria of a good study topic

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Historical Aspects
Book of Daniel First
Clinical Research in
562 BC
Canon of medicine
Basis of modern CT
10th AD
James Lind & scurvy
trial 18th AD
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7. All a Clinical Research is ABOUT
Scientifically valid conclusion
Interpreting data correctly
Applying biostats
Sample size determination Applying right statistical test
Protocol development
Study design determination
Formulating Research Question
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8. Clues to ask the Right Question
Be a close OBSERVER during ward rounds
Eavesdrop the teachers
Look for pts with unusual ds. manifestations
Focus on refractory cases
PICOT criteria of a good research question
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EVERY DIFFICULT CASE IS A POTENTIAL RESEARCH TOPIC

9. Study designs
Descriptive
Individuals
Case reports Case series
Cross-
sectional
surveys
Populations
Ecological
studies
Analytical
Observational
Case control
Cohort
studies
Interventional
Clinical Trials
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10. Evidence Pyramid
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11. Study Protocol
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STUDY RATIONALE OBJECTIVES - SMART METHODOLOGY WHICH
INCLUDES PLAN FOR
STATISTICAL ANALYSIS
ETHICAL PRINCIPLES
A written document that details

12. Ask YOURSELF
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WHAT to do? WHY did I begin? What did I do? What did I
Find?
What it means?

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14. Techniques of Patient
oriented research
Charles Y C Pak, Perrie
M Adams. Raven
Press, New York
Handbook of Clinical
Research.
By: Liyod Julia.
Churchil Livingstone
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