For M.G.M. PG Orientation Program
Why do Research? (1/3)
24-11-2023
For P.G. Orientation Program_MGM 2
Why bother? (2/3)
24-11-2023
For P.G. Orientation Program_MGM 3
Why ME? (3/3)
24-11-2023
For P.G. Orientation Program_MGM 4
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:
For P.G. Orientation Program_MGM 24-11-2023 5
FINER criteria of a good study topic
24-11-2023
For P.G. Orientation Program_MGM 6
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
24-11-2023
For P.G. Orientation Program_MGM 6
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
For P.G. Orientation Program_MGM 24-11-2023 7
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
For P.G. Orientation Program_MGM 24-11-2023 8
EVERY DIFFICULT CASE IS A POTENTIAL RESEARCH TOPIC
Study designs
Descriptive
Individuals
Case reports Case series
Cross-
sectional
surveys
Populations
Ecological
studies
Analytical
Observational
Case control
Cohort
studies
Interventional
Clinical Trials
24-11-2023
For P.G. Orientation Program_MGM 9
Evidence Pyramid
24-11-2023
For P.G. Orientation Program_MGM 10
Study Protocol
For P.G. Orientation Program_MGM 24-11-2023 11
STUDY RATIONALE OBJECTIVES - SMART METHODOLOGY WHICH
INCLUDES PLAN FOR
STATISTICAL ANALYSIS
ETHICAL PRINCIPLES
A written document that details
Ask YOURSELF
For P.G. Orientation Program_MGM 24-11-2023 12
WHAT to do? WHY did I begin? What did I do? What did I
Find?
What it means?
24-11-2023
For P.G. Orientation Program_MGM 13
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
24-11-2023
For P.G. Orientation Program_MGM 14
24-11-2023
For P.G. Orientation Program_MGM 15
24-11-2023
For P.G. Orientation Program_MGM 16
24-11-2023
For P.G. Orientation Program_MGM 17
24-11-2023
For P.G. Orientation Program_MGM 18
24-11-2023
For P.G. Orientation Program_MGM 19
24-11-2023
For P.G. Orientation Program_MGM 20

Basics_Clinical_Research_Dr_SSD_Slideshare.pptx